FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Bexsero in adolescents from 11 years of age and adults (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia as well as pain, swelling, hardness and redness of the skin at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Bexsero fl-adolexxenti mill-età ta' 11-il sena u fl-adulti (li dehru f'aktar minn 1 minn kull 10) huma uġigħ ta' ras, nawsja (tħossok imdardar) u telqa (tħossok ma tiflaħx), mijalġija (uġigħ fil-muskoli) u artralġja (uġigħ fil-ġogi) kif ukoll uġigħ, nefħa, ebusija u ħmura tal-ġilda fis-sit tal-injezzjoni.
English: As for all medicines, data on the use of Bexsero are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Bexsero hija ssorveljata kontinwament.
English: What are the risks associated with Bexsero?
Maltese: X'inhuma r-riskji assoċjati ma' Bexsero?
English: Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B).
Maltese: Bexsero huwa vaċċin li jintuża biex jipproteġi individwi mill-età ta' xahrejn minn mard meningokokkali invażiv ikkawżat minn grupp wieħed tal-batterju Neisseria meningitidis (grupp B).
English: Bexsero has been shown to produce a robust immune response to N. meningitidis group B and the risks are acceptable.
Maltese: Bexsero wera li jipproduċi rispons immuni robust għal N. meningitidis grupp B u r-riskji huma aċċettabbli.
English: For the full list of side effects and restrictions with Bexsero, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet bi Bexsero, ara l-fuljett ta' tagħrif.
English: It is given by deep injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in children under two years old.
Maltese: Dan jingħata permezz ta' injezzjoni profonda ġol-muskolu, preferibbilment ġol-muskolu talispalla, jew ġol-muskolu tal-koxxa fi tfal li għandhom inqas minn sentejn.
English: The first main study involved 2,627 children who were two months old when the study started.
Maltese: L-ewwel studju prinċipali involva lil 2,627 tifel u tifla li kellhom xahrejn meta beda l-istudju.
English: What measures are being taken to ensure the safe and effective use of Bexsero?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Bexsero?
English: Bexsero contains four proteins which are found on the surfaces of cells of the N. meningitidis group B bacterium.
Maltese: Bexsero fih erba' proteini li jinsabu fuq l-uċuh ta' ċelloli tal-batterju N. meningitidis grupp B.
English: The effects of giving three doses of Bexsero at two-month intervals together with other routine infant vaccinations were compared with giving the routine vaccinations alone.
Maltese: L-effetti tal-għoti ta' tliet dożi ta' Bexsero f'intervalli ta' xahrejn flimkien ma' tilqim ta' rutina ieħor għat-trabi, tqabblu mal-għoti ta' tilqim ta' rutina waħdu.
English: A smaller supportive study was also carried out in adults and similar results were seen in this study.
Maltese: Sar ukoll studju ta' sostenn iżgħar fl-adulti u f'dan l-istudju dehru riżultati simili.
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. In addition, a single booster dose of Bexsero at 12 months of age produced a stronger immune response in children who had already received Bexsero than the first of two ‘catchup' doses in children of the same age who had not.
Maltese: Barra minn hekk, doża booster waħda ta' Bexsero fl-età ta' 12il xahar ipproduċiet rispons immuni aktar b'saħħtu fi tfal li diġà kienu rċivew Bexsero mill-ewwel doża minn żewġ dożi "catch-up" fi tfal tal-istess età li ma kinux irċivew Bexsero.
English: Two main studies showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. The studies measured the production of protective antibodies which are able to kill the bacteria.
Maltese: L-effetti sekondarji rrappurtati b'Bexsero huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: This means that the proteins are fixed onto a compound containing aluminium, to stimulate a better immune response.
Maltese: Dan ifisser li l-proteini jeħlu fuq kompost li fih l-aluminju sabiex jistimulaw rispons immuni aħjar.
English: The European Medicines Agency decided that Bexsero's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Bexsero huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: How does Bexsero work?
Maltese: Kif jintuża Bexsero?
English: How is Bexsero used?
Maltese: X'inhu Bexsero u għal xiex jintuża?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi “jgħallmu” lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-mard.
English: The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B and that two doses were needed to produce an adequate immune response.
Maltese: L-istudju wera li Bexsero kien effettiv biex jistimula rispons immuni għal N. meningitidis grupp B u li kienu meħtieġa żewġ dożi biex jipproduċu rispons immuni adegwat.
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Maltese: Mard invażiv iseħħ meta l-batterji jinfirxu mal-ġisem u jikkawżaw infezzjonijiet serji bħall-meninġite (infezzjoni talmembrani li jiċċirkondaw il-moħħ u s-sinsla tad-dahar) u sepsi (infezzjoni tad-demm).
English: Xagrid (anagrelide) EMA/326376/2018
Maltese: Xagrid (anagrelid) EMA/326376/2018
English: Further information on Xagrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Xagrid (anagrelide)
Maltese: Xagrid (anagrelid)
English: Xagrid is available as capsules (0.5 mg).
Maltese: Xagrid jiġi bħala kapsuli (0.5 mg).
English: Xagrid received a marketing authorisation valid throughout the EU on 16 November 2004.
Maltese: Xagrid ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Novembru 2004.
English: In the largest study, 67% of the patients with essential thrombocythaemia (628 out of 934), and 66% of those who could not tolerate other treatments or whose condition did not respond to them (480 out of 725) had a complete response to Xagrid.
Maltese: Fl-ikbar studju, 67 % mill-pazjenti bit-tromboċitemija essenzjali (628 minn 934), u 66 % minn dawk li ma setgħux jittolleraw kuri oħra li l-kundizzjoni tagħhom ma rrispondietx għalihom (480 minn 725) kellhom rispons komplet għal Xagrid.
English: Xagrid contains the active substance anagrelide.
Maltese: Xagrid fih is-sustanza attiva anagrelid.
English: This summary was last updated in 06-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2018.
English: This is because, as a result of the disease's rarity, it had not been possible to obtain full information about it. As the company has supplied the additional information requested, the ‘exceptional circumstances' ended on 11.07.2018.
Maltese: Peress li l-kumpanija pprovdiet l-informazzjoni addizzjonali mitluba, iċ-“ċirkostanzi ta' eċċezzjoni” ntemmu fi 11.07.2018.
English: Other information about Xagrid
Maltese: Aktar informazzjoni dwar Xagrid
English: The dose can then be increased every week by 1 capsule a day, until the patient's platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the usual level in healthy people).
Maltese: Id-doża tista' tiżdied kull ġimgħa b'kapsula waħda kuljum, sakemm il-pazjent jikseb għadd ta' pjastrini inqas minn 600 miljun pjastrina għal kull millilitru, u idealment bejn 150 u 400 miljun/ml (il-livell li normalment jiġi osservat f'persuni b'saħħithom).
English: The active substance in Xagrid, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Maltese: Is-sustanza attiva f'Xagrid, lanagrelid, timblokka l-iżvilupp u t-tkabbir ta' ċelloli fil-mudullun li jissejħu “megakarjoċiti”, li jipproduċu l-pjastrini.
English: Almost 3,000 of the patients in the studies had essential thrombocythaemia, with a platelet count of more than 600 million/ml.
Maltese: Kważi 3,000 pazjent fl-istudji kellhom tromboċitemija essenzjali, b'għadd ta' pjastrini ta' iktar minn 600 miljun/ml.
English: As for all medicines, data on the use of Xagrid are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Xagrid hija ssorveljata kontinwament.
English: What are the risks associated with Xagrid?
Maltese: X'inhuma r-riskji assoċjati ma' Xagrid?
English: In essential thrombocythaemia the bone marrow produces too many platelets.
Maltese: Fit-tromboċitemija essenzjali il-mudullun jipproduċi wisq pjastrini.
English: The main measure of effectiveness was the number of patients who had a ‘complete response', when platelet counts fell either by at least 50% from the start of treatment or to below 600 million/ml.
Maltese: Il-kejl ewlieni taleffikaċja kien l-għadd ta' pazjenti li kellhom “rispons komplet”, fejn l-għadd ta' pjastrini naqas b'talanqas 50 % mill-bidu tal-kura jew sa taħt is-600 miljun/ml.
English: In the other three studies, between 60 and 82% of patients had a complete response.
Maltese: Fit-tliet studji l-oħra, bejn 60 u 82 % tal-pazjenti kellhom rispons komplet.
English: Xagrid is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets in the blood).
Maltese: Xagrid huwa mediċina li tintuża biex tnaqqas l-għadd ta' pjastrini (komponenti li jgħinu fit-tagħqid taddemm) f'pazjenti li jbatu minn tromboċitemija essenzjali (marda fejn ikunu qegħdin jiċċirkolaw wisq pjastrini fid-demm). “Essenzjali” tfisser li l-marda m'għandha l-ebda kawża ovvja.
English: Xagrid was effective in lowering platelet counts in four main studies involving patients with various diseases in which the bone marrow produces too many cells.
Maltese: Xagrid kien effettiv fit-tnaqqis tal-għadd ta' pjastrini f'erba' studji ewlenin li kienu jinvolvu pazjenti li jbatu minn diversi mard fejn il-mudullun jipproduċi wisq ċelloli.
English: How does Xagrid work?
Maltese: Kif jintuża Xagrid?
English: The recommended starting dose is 1 capsule twice a day.
Maltese: Id-doża inizjali rakkomandata hija kapsula waħda darbtejn kuljum.
English: Side effects reported with Xagrid are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Xagrid huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa għallprotezzjoni tal-pazjenti.
English: Why is Xagrid authorised in the EU?
Maltese: Għaliex Xagrid ġie awtorizzat fl-UE?
English: Xagrid was not compared with any other medicines.
Maltese: Xagrid ma tqabbilx ma' mediċini oħra.
English: Xagrid must not be used in patients with moderate or severe liver or kidney disease.
Maltese: Xagrid m'għandux jintuża f'pazjenti b'mard moderat jew gravi fil-fwied jew fil-kliewi.
English: Xagrid is used when patients do not respond to or do not tolerate their current treatment, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Maltese: Xagrid jintuża meta pazjenti ma jirrispondux jew ma jittollerawx il-kura attwali tagħhom, u meta jkunu ‘f'riskju' minħabba l-età tagħhom (iktar minn 60 sena), meta jkollhom għadd kbir ħafna ta' pjastrini jew ikunu diġà kellhom problemi ta' tagħqid tad-demm.
English: For the full list of all side effects of Xagrid, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha ta' Xagrid, ara l-fuljett ta' tagħrif.
English: ● and is advanced.
Maltese: ● u huwa avanzat.
English: multiple sclerosis)
Maltese: sklerożi multipla)
English: System organ class ADRs (MedDRA)
Maltese: Klassi tas-sistemi u tal-organi ADRs (MedDRA)
English: ● The active substance is alectinib.
Maltese: ● Is-sustanza attiva hi alectinib.
English: The absolute bioavailability of alectinib capsules was 36.9% (90% CI: 33.9%, 40.3%) under fed conditions in healthy subjects.
Maltese: Il-bijodisponibilità assoluta ta' kapsuli alectinib kienet ta' 36.9% (CI ta' 90%: 33.9%, 40.3%) wara likel f'individwi f'saħħithom.
English: (range 0.5 - 29.0)
Maltese: (firxa 0.5 - 29.0)
English: 56 hard capsules
Maltese: 56 kapsula iebsa.
English: 224 (4 packs of 56) hard capsules
Maltese: 224 (4 pakketti ta' 56) kapsula iebsa
English: Frequency category (all grades)
Maltese: Kategorija ta' frekwenza (gradi kollha)
English: Increased alkaline phosphatase**
Maltese: Żieda fl-alkaline phosphatase**
English: (range 0.3 - 27.0)
Maltese: (firxa 0.3 - 27.0)
English: INFORMATION IN BRAILLE alecensa
Maltese: INFORMAZZJONI BIL-BRAILLE alecensa
English: Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
Maltese: Kontenut tal-kapsula Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
English: Figure 1: Kaplan Meier Plot of INV Assessed PFS in BO28984 (ALEX)
Maltese: Figura 1 Kaplan Meier Plot ta' PFS evalwata mill-INV f'BO28984 (ALEX)
English: (range 1 - 30)
Maltese: (firxa 1 - 30)
English: Effects of age, body weight, race and gender
Maltese: Effetti tal-età, piż tal-ġisem, razza u sess
English: ORR (INV)*, *** Responders n (%) [95% CI]
Maltese: ORR (INV)*, *** Persuni li rrispondew n (%) [CI ta' 95%]
English: Date of latest renewal: 1 December 2017
Maltese: Data tal-aħħar tiġdid: 1 ta' Diċembru 2017
English: Stratified log-rank p-value p <0.0001
Maltese: Valur p log-rank stratifikat p < 0.0001
English: Do not take Alecensa:
Maltese: Tiħux Alecensa:
English: 240 hard capsules
Maltese: 240 kapsula iebsa
English: (range 1 - 29)
Maltese: (firxa 1 - 29)
English: Pack size: 240 hard capsules.
Maltese: Daqs tal-pakkett: 240 kapsula iebsa.
English: The ADRs listed in Table 3 are presented by system organ class and frequency categories, 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 <1/1000), very rare (<1/10,000).
Maltese: L-ADRs elenkati f'Tabella 3 huma ppreżentati skont il-klassi tas-sistemi u tal-organi u l-kategoriji ta' frekwenza, definiti 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 < 1/1000), rari ħafna (< 1/10,000).
English: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; ULN = upper limit of normal a
Maltese: AST= aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE= Kriterji ta' Terminoloġija Komuni ta' NCI għal Avvenimenti Avversi;
English: Heart rate less than 60 beats per minute (bpm).
Maltese: Rata tat-taħbit tal-qalb inqas minn 60 taħbita kull minuta (bpm - beats per minute).
English: A risk for induction of CYP2B6 and PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Maltese: Riskju ta' induzzjoni ta' CYP2B6 u enzimi regolati permezz ta' PXR minbarra CYP3A4 ma jistax jiġi eskluż kompletament.
English: Permanently discontinue Alecensa.
Maltese: Waqqaf Alecensa b'mod permanenti.
English: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
Maltese: Kull kapsula iebsa fiha 33.7 mg lactose (bħala monohydrate) u 6 mg sodium (bħala sodium laurilsulfate).
English: NP28761 Alecensa 600 mg twice daily
Maltese: NP28761 Alecensa 600 mg darbtejn kuljum
English: Study NP28761
Maltese: Studju NP28761
English: Alecensa contains sodium
Maltese: Alecensa fih sodium
English: Constipation (35%), nausea (19%), diarrhoea (16%) and vomiting (11%) were the most commonly reported gastrointestinal (GI) reactions.
Maltese: Stitikezza (35%), dardir (19%), dijarea (16%) u rimettar (11%) kienu l-aktar reazzjonijiet gastrointestinali (GI - gastrointestinal) irrappurtati b'mod komuni.
English: Baseline demographic and disease characteristics for Alecensa were median age 58 years (54 years for crizotinib), 55% female (58% for crizotinib), 55% non-Asian (54% for crizotinib), 61% with no smoking history (65% for crizotinib), 93% ECOG PS of 0 or 1 (93% for crizotinib), 97% Stage IV disease (96% for crizotinib), 90% adenocarcinoma histology (94% for crizotinib), 40% CNS metastases at baseline (38% for crizotinib) and 17% having received prior CNS radiation (14% for crizotinib).
Maltese: Il-punt finali primarju tal-prova kien li juri ssuperjorità ta' Alecensa kontra crizotinib ibbażat fuq is-sopravivenza Mingħajr Progressjoni (PFSProgression Free survival) skont il-valutazzjoni tal-investigatur bl-użu ta' RECIST 1.1. Karatteristiċi demografiċi u tal-marda fil-linja bażi għal Alecensa kienu età medjana ta' 58 sena (54 sena għal crizotinib), 55% kienu nisa (58% għal crizotinib), 55% ma kinux Asjatiċi (54% għal crizotinib), 61% qatt ma pejpu fil-passat (65% għal crizotinib), 93% kellhom ECOG PS ta' 0 jew 1 (93% għal crizotinib), 97% kellhom marda ta' Stadju IV (96% għal crizotinib), 90% kellhom istoloġija ta' adenokarċinoma (94% għal crizotinib), 40% kellhom metastasi fis-CNS fil-linja bażi (38% għal crizotinib) u 17% kienu rċevew radjazzjoni preċedenti għas-CNS (14% għal crizotinib).
English: The demographic characteristics of the overall study population were 84% Caucasian, 8% Asian, 55% females.
Maltese: Il-karatteristiċi demografiċi tal-popolazzjoni globali tal-istudju kienu 84% Kawkasi, 8% Asjatiċi, 55% nisa.
English: Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate.
Maltese: Dożi multipli ta' 600 mg alectinib ma kellhom l-ebda influwenza fuq l-esponiment għal midazolam (2 mg), sottostrat sensittiv ta' CYP3A.
English: ● Capsule content: lactose monohydrate (see section 2 ‘Alecensa contains lactose'), hydroxypropylcellulose, sodium laurilsulfate (see section 2 ‘Alecensa contains sodium'), magnesium stearate and carmellose calcium
Maltese: ● Kontenut tal-kapsula: lactose monohydrate (ara sezzjoni 2 ‘Alecensa fih lactose'), hydroxypropylcellulose, sodium laurilsulfate (ara sezzjoni 2 ‘Alecensa fih sodium'), magnesium stearate u carmellose calcium
English: The median age was 54 years.
Maltese: L-età medjana kienet ta' 54 sena.
English: Alecensa contains lactose (a type of sugar).
Maltese: Alecensa fih lactose (tip ta' zokkor).
English: Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules.
Maltese: Folji magħmula minn aluminju/aluminju (PA/Alu/PVC/Alu) li fihom 8 kapsuli ibsin.
English: Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase'.
Maltese: Alecensa jimblokka l-azzjoni ta' enzima li tissejjaħ ‘ALK tyrosine kinase'.
English: N=126 NE [NE; NE]
Maltese: N=126 NE
English: Time to CNS progression (IRC)*, ** Number of patients with event n (%)
Maltese: Żmien sa progressjoni għas-CNS (IRC)*, ** Numru ta' pazjenti b'avveniment n (%)
English: The major metabolite of alectinib (M4) has shown similar in vitro potency and activity.
Maltese: Il-metabolit maġġuri ta' alectinib (M4) wera potenza u attività in vitro simili.
English: See ‘Side effects' in section 4 for more information.
Maltese: Ara ‘Effetti sekondarji' fis-sezzjoni 4 għal aktar informazzjoni.
English: Alectinib demonstrated in vitro and in vivo activity against mutant forms of the ALK enzyme, including mutations responsible for resistance to crizotinib.
Maltese: Alectinib wera attività in vitro u in vivo kontra forom mutanti tal-enzima ALK, inklużi mutazzjonijiet responsabbli għal reżistenza għal crizotinib.
English: Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Maltese: Qoxra tal-kapsula Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
English: ● medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
Maltese: ● mediċini li jintużaw biex jikkuraw it-tuberkulożi (eż. rifampicin, rifabutin)
English: M4 has shown similar in vitro potency and activity against ALK.
Maltese: M4 wera effikaċja u attività kontra ALK in vitro simili.
English: Pack size: 224 (4 packs of 56) hard capsules.
Maltese: Daqs tal-pakkett: 224 (4 pakketti ta' 56) kapsula iebsa.
English: Alectinib and its major metabolite M4 are highly bound to human plasma proteins (>99%), independent of active substance concentration.
Maltese: Alectinib u l-metabolit prinċipali tiegħu M4 jintrabtu ħafna mal-proteini tal-plażma umana (> 99%), indipendentement mill-konċentrazzjoni tas-sustanza attiva.
English: ● slow heart beat (bradycardia).
Maltese: ● rata ta' taħbit tal-qalb baxxa (bradikardija).
English: The range of body weights for patients enrolled in clinical studies is 36.9-123 kg.
Maltese: Il-firxa ta' piżijiet tal-ġisem għall-pazjenti rreġistrati fi studji kliniċi hija minn 36.9-123 kg.
English: ● Capsule shell: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch and carnauba wax
Maltese: ● Qoxra tal-kapsula: hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), maize starch u carnauba wax
English: ECOG PS (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no) were stratification factors for randomisation.
Maltese: ECOG PS (0/1 vs. 2), ir-razza (Asjatiċi vs mhux Asjatiċi), u metastasi fis-CNS fil-linja bażi (iva vs. le) kienu fatturi ta' stratifikazzjoni għal randomisation.
English: The demographic characteristics of the overall study population were 67% Caucasian, 26% Asian, 56% females, and the median age was 52 years.
Maltese: Il-karatteristiċi demografiċi tal-popolazzjoni globali tal-istudju kienu 67% Kawkasi, 26% Asjatiċi, 56% nisa, u l-età medjana kienet ta' 52 sena.
English: Formation of metabolite M1b and its minor isomer M1a is likely to be catalyzed by a combination of CYP isozymes (including isozymes other than CYP3A) and aldehyde dehydrogenase (ALDH) enzymes.
Maltese: Il-formazzjoni tal-metabolit M1b u tal-isomeru minuri tiegħu M1a x'aktarx li hija katalizzata minn taħlita ta' isożimi CYP (inklużi isożimi oħra minbarra CYP3A) u enzimi aldehyde dehydrogenase (ALDH).
English: 450 mg twice daily
Maltese: 450 mg darbtejn kuljum
English: Increased blood creatine phosphokinase
Maltese: Żieda ta' creatine phosphokinase fid-demm
English: A summary of pooled analysis of CNS endpoints is presented in Table 6.
Maltese: Sommarju tal-analiżi miġbura tal-punti finali tas-CNS huwa ppreżentat fit-Tabella 6.
English: In vitro studies indicate that neither alectinib nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations.
Maltese: Studji in vitro jindikaw li la alectinib u lanqas il-metabolit attiv maġġuri tiegħu (M4) ma jinibixxu CYP1A2, CYP2B6, CYP2C9, CYP2C19, jew CYP2D6 f'konċentrazzjonijiet rilevanti klinikament.
English: Table 4 Summary of efficacy results from study BO28984 (ALEX)
Maltese: Tabella 4 Sommarju tar-riżultati tal-effikaċja minn studju BO28984 (ALEX)