FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems.
Maltese: Studji fi tfal qabel l-età tal-iskola li kienu esposti għal valproate fil-ġuf juru li sa 30-40% jkollhom dewmien fl-iżvilupp bikri tagħhom bħal jitkellmu u jimxu aktar tard, inqas ħiliet intellettwali, ħiliet lingwistiċi dgħajfa (jitkellmu u jifmhu) u problemi bil-memorja.
English: • Make sure you are using an effective method of contraception.
Maltese: • Aċċerta ruħek li inti qed tuża metodu effettiv ta' kontraċezzjoni.
English: Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
Maltese: Difetti tat-twelid li ġew irrappurtati jinkludu spina bifida (fejn l-għadam tassinsla ma jkunux żviluppati sew); formazzjonijiet difettużi tal-wiċċ u tal-għadam tar-ras, formazzjonijiet difettużi tal-qalb, tal-kliewi, tal-passaġġ tal-awrina u tal-organi sesswali; difetti fid-dirgħajn u r-riġlejn.
English: Section 4.3 Contraindications [The text below is only to be implemented where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Maltese: Sezzjoni 4.3 Kontraindikazzjonijiet [Il-kitba hawn taħt għandha tiġi implimentata biss fejn l-awtorizzazzjoni għat-tqegħid fis-suq bħalissa tinkludi l-indikazzjoni ta' profilassi ta' attakki tal-emigranja]
English: Risk in the neonate
Maltese: Parir importanti għan-nisa
English: • During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child. [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar indications]
Maltese: • Waqt it-tqala, attakki tonic clonic u status epilepticus b'ipoksja fl-omm jistgħu jġorru riskju partikolari ta' mewt għall-omm u għat-tarbija mhux imwielda.
English: Available data suggest that antiepileptic polytherapy including valproate is associated with a greater risk of congenital malformations than valproate monotherapy.
Maltese: Dejta disponibbli tissuġġerixxi li politerapija kontra l-epilessija li tikludi valproate hija assoċjata ma' riskju akbar ta' formazzjonijiet konġenitali difettużi milli terapija b'valproate waħdu.
English: Female children, female adolescents and woman of childbearing potential (see above and section 4.4)
Maltese: Tfal bniet, adolexxenti nisa u nisa f'età li jista' jkollhom it-tfal (ara fuq u sezzjoni 4.4)
English: Hematological disorders have been shown in breastfed newborns/infants of treated women (see section 4.8).
Maltese: Intwerew disturbi ematoloġiċi fi trabi tat-twelid/trabi ta ‘nisa kkurati (ara sezzjoni 4.8).
English: • The nature and the magnitude of the risks of exposure during pregnancy, in particular the teratogenic risks and the risks of developmental disorders.
Maltese: • In-natura u l-kobor tar-riskji ta' esponiment waqt it-tqala, b'mod partikolari r-riskji teratoġeniċi u r-riskju ta' disturbi fl-iżvilupp.
English: Ask your doctor about taking folic acid.
Maltese: Staqsi lit-tabib tiegħek biex tieħu folic acid.
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Maltese: Dejta uriet li esponiment għal valproate fil-ġuf jista' jkollu effetti avversi fuq l-iżvilupp mentali u fiżiku fit-tfal esposti.
English: However, this syndrome must be distinguished from the decrease of the vitamin-K factors induced by phenobarbital and enzymatic inducers.
Maltese: Madankollu, dan is-sindrome għandu jingħaraf mit-tnaqqis tal-fatturi tal-vitamina K ikkaġunati minn phenobarbital u indutturi tal-enzimi.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Maltese: Kellem lit-tabib tiegħek jew klinika ta' ippjanar tal-familja jekk teħtieġ parir dwar il-kontraċezzjoni.
English: • Do not stop using your contraception before you have talked to your doctor and worked together on a plan to ensure your epilepsy/bipolar disorder is controlled and the risks to your baby are reduced.
Maltese: • Tiqafx tuża l-kontraċezzjoni tiegħek qabel ma tkun kellimt lit-tabib tiegħek u flimkien taħdmu fuq pjan biex taċċertaw ruħkom li l-epilessija/d-disturb bipolari tiegħek huwa kkontrollat u r riskji għat-tarbija tiegħek jitnaqqsu.
English: Female children, female adolescents, women of childbearing potential and pregnant women
Maltese: Tfal bniet, adolexxenti nisa, nisa f'età li jista' jkollhom it-tfal u nisa tqal
English: The benefit and risk should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with <invented name> plans a pregnancy or if she becomes pregnant.
Maltese: Il-benefiċċju u r-riskju għandhom jitqiesu bir-reqqa mill-ġdid b'mod regolari meta tiġi riveduta l-kura, fil-pubertà u b'mod urġenti meta mara f'età li jista' jkollha ttfal li tkun qed tiġi kkurata b'<isem ivvintat> tippjana tqala jew jekk hija tinqabad tqila.
English: - To institute specialized prenatal monitoring in order to detect the possible occurrence of neural tube defects or other malformations.
Maltese: - Li jinbeda monitoraġġ speċjalizzat qabel it-tqala sabiex tiġi nnutata l-possibbiltà ta' okkorrenza ta' difetti fil-passaġġ tan-nervituri jew formazzjonijiet difettużi oħra.
English: However the available evidence does not suggest it prevents the birth defects or malformations due to valproate exposure.
Maltese: Dejta disponibbli turi żieda fl-inċidenza ta' formazzjonijiet difettużi żgħar u kbar.
English: - Folate supplementation before the pregnancy may decrease the risk of neural tube defects common to all pregnancies.
Maltese: - Supplimentazzjoni b'folate qabel it-tqala tista' tnaqqas ir-riskju ta' difetti fil-passaġġ tannervituri li huwa komuni għat-tqaliet kollha.
English: Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of <invented name> during pregnancy (see section 4.6).
Maltese: Nisa f'età li jista' jkollhom it-tfal għandhom jużaw kontraċezzjoni effettiva waqt il-kura u għandhom jiġu infurmati bir-riskji assoċjati mal-użu ta' <isem ivvintat> waqt it-tqala (ara sezzjoni 4.6).
English: Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ.
Maltese: Għalkemm ir-rwol ta' fatturi oħra li jfixklu ma jistax jiġi eskluż, fi tfal esposti għal valproate hemm xhieda li r-riskju ta' indeboliment intellettwali jista' jkun indipendenti mill-IQ tal-omm.
English: • Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
Maltese: • Disturbi tal-ispektrum tal-awtiżmu jiġu dijanjostikati iktar ta' spiss fi tfal esposti għal valproate u hemm xi evidenza li t-tfal għandhom possibbiltà akbar li jiżviluppaw sintomi ta' Disturb ta' Nuqqas ta' Attenzjoni u/jew Attività Eċċessiva (ADHD).
English: PACKAGE LEAFLET
Maltese: TQALA MHUX
English: The prescriber must ensure that the patient is provided with comprehensive information on the risks alongside relevant materials, such as a patient information booklet, to support her understanding of the risks.
Maltese: Il-persuna li qed tordna l-mediċina għandha taċċerta ruħha li l-pazjenta tingħatalha informazzjoni sħiħa dwar ir-riskji flimkien ma' materjali rilevanti, bħal ma huwa ktejjeb ta' informazzjoni għall-pazjent, biex tgħinha tifhem ir-riskji.
English: <Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate.
Maltese: Jekk din hija l-ewwel darba li inti ordnawlek valproate it-tabib tiegħek se jkun spjegalek ir-riskji għattarbija fil-ġuf jekk inti tinqabad tqila.
English: This hemorrhagic syndrome is related to thrombocytopenia, hypofibrinogenemia and/or to a decrease in other coagulation factors.
Maltese: Għalhekk fit-trabi tat-twelid għandhom jiġu investigati, l-għadd talplejtlits, il-livell tal-fibrinoġin fil-plażma, testijiet tal-koagulazzjoni u l-fatturi ta' koagulazzjoni.
English: There are limited data on the long term outcomes.
Maltese: Hemm dejta limitata dwar riżultati wara tul ta' żmien.
English: <Invented name> should be initiated and supervised by a specialist experienced in the management of <epilepsy> <or> <bipolar disorder>.
Maltese: <Isem ivvintat> għandu jinbeda u jiġi ssorveljat minn speċjalista b'esperjenza fl-immaniġġjar tal<epilessija> <jew> <disturb bipolari>.
English: [All text below should be inserted only where the marketing authorisation currently includes the indications epilepsy and/or bipolar disorders] Valproate therapy should not be discontinued without a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of <epilepsy> <or> <bipolar disorder>.
Maltese: Terapija b'valproate għandha titkompla biss wara stima mill-ġdid tal-benefiċċji u r-riskji tal-kura b'valproate għall-pazjent minn tabib b'esperjenza fl-immaniġġjar ta' <epilessija> <jew> <disturb bipolari>.
English: <Invented name> is contraindicated for prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6 above).
Maltese: <Isem ivvintat> huwa kontraindikat għall-profilassi ta' attakki tal-emigranja fit-tqala u f'nisa li jista' jkollhom it-tfal li mhumiex qed jużaw metodi effettivi ta' kontraċezzjoni waqt il-kura b' valproate (ara sezzjonijiet 4.4 u 4.6 aktar ‘il fuq).
English: [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Maltese: [Il-paragrafu hawn taħt għandu jiddaħħal biss fejn l-awtorizzazzjoni għat-tqegħid fis-suq bħalissa tinkludi l-indikazzjoniji “profilassi ta' attakki tal-emigranja”].
English: <Invented name> is contraindicated as migraine prophylaxis in pregnant women and in women of childbearing potential, who do not use effective methods of contraception, as sufficient therapeutic alternatives are present (see section 4.3).
Maltese: <Isem ivvintat> huwa kontraindikat bħala profilassi għall-emigranja f'nisa tqal u f'nisa f'età li jista' jkollhom it-tfal, li ma jużawx metodi effettivi ta' kontraċezzjoni, minħabba li jeżistu biżżejjed alternattivi terapewtiċi (ara sezzjoni 4.3).
English: Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Maltese: Il-folic acid jista' jnaqqas ir-riskju ġenerali ta' spina bifida u korriment bikri li jeżisti fit-tqaliet kollha.
English: • Ask your doctor about taking folic acid when trying for a baby.
Maltese: • Staqsi lit-tabib tiegħek biex tieħu folic acid meta tkun qed tipprova għal tarbija.
English: • If a woman plans a pregnancy or becomes pregnant, valproate therapy should be stopped.
Maltese: • Jekk mara tippjana tqala jew tinqabad tqila, it-terapija b'valproate għandha titwaqqaf.
English: Preferably <invented name> should be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation to avoid high peak plasma concentrations.
Maltese: L-aħjar huwa li <isem ivvintat> jiġi ordnat bħala monoterapija u bl-aktar doża baxxa effettiva, jekk possibbli bħala formulazzjoni li tintreħa bil-mod sabiex jiġi evitat li l-ogħla konċentrazzjonijiet fil-plażma jkunu għolja.
English: Valproate administration may also impair fertility in men (see section 4.8).
Maltese: L-għoti ta' valproate jista' wkoll jindebolixxi l-fertilità fl-irġiel (ara sezzjoni 4.8).
English: CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Maltese: L-KURA [Il-paragrafu hawn taħt għandu jiddaħħal biss fejn l-awtorizzazzjoni għat-tqegħid fis-suq bħalissa tinkludi l-indikazzjoni “profilassi ta' attakki tal-emigranja”].
English: The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
Maltese: Ir-riskju huwa dipendenti mid-doża iżda ma jistax jiġi stabbilit livell ta' doża li inqas minnu ma jkun jeżisti lebda riskju.
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders>.
Maltese: Il-kura b'<isem ivvintat> għandu jinbeda u jkun taħt is-superviżjoni ta' tabib speċjalizzat fil-kura ta' <epilessija> <jew> <disturbi bipolari>.
English: Further information on Bavencio can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bavencio.
Maltese: ema.europa.eu/medicines/human/EPAR/bavencio.
English: Bavencio contains the active substance avelumab.
Maltese: Bavencio fih is-sustanza attiva avelumab.
English: Bavencio received a conditional marketing authorisation valid throughout the European Union on 18 September 2017.
Maltese: Bavencio rċieva awtorizzazzjoni kkundizzjonata għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fit18 ta' Settembru 2017.
English: Merkel cell carcinoma
Maltese: Karċinoma taċ-ċellola Merkel
English: Other information about Bavencio
Maltese: Informazzjoni oħra dwar Bavencio
English: For MCC, Bavencio has been given ‘conditional approval'.
Maltese: Għal MCC, Bavencio ngħata ‘approvazzjoni kkundizzjonata'.
English: PD-L1 usually attaches to cells of the immune (defence) system called T cells, preventing the T cells from attacking the cancer cells.
Maltese: PD-L1 normalment taqbad ma' ċelloli tas-sistema immunitarja (difiża) li jissejħu ċelloli T, u tipprevjeni ċ-ċelloli T milli jattakkaw iċ-ċelloli tal kanċer.
English: In a main study involving 88 patients with metastatic MCC who had received previous treatment with chemotherapy (cancer medicines), around 33% of patients (29 out of 88) were considered to have had a reduction in tumour size or no sign of it after treatment with the medicine; in most of these patients, the response lasted for at least 6 months.
Maltese: Fi studju ewlieni li kien jinvolvi 88 pazjent b'MCC metastatika li kienu rċevew kura preċedenti bilkimoterapija (mediċini kontra l-kanċer), madwar 33 % tal-pazjenti (29 minn 88) kienu kkunsidrati li kellhom tnaqqis fid-daqs tat-tumur jew ma kien hemm l-ebda sinjal tiegħu wara l-kura bil-mediċina; fil-biċċa l-kbira ta' dawn il-pazjenti, ir-rispons dam għal mill-inqas 6 xhur.
English: The active substance in Bavencio, avelumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand-1' (PD-L1), which is present on the surface of many cancer cells.
Maltese: Is-sustanza attiva f'Bavencio, l-avelumab, hija antikorp monoklonali, tip ta' proteina mfassla biex tagħraf u teħel ma' proteina msejħa “ligand 1 tal-mewt ipprogrammat” (“programmed death-ligand-1”) (PD-L1), li hija preżenti fuq il-wiċċ ta' ħafna ċelloli tal-kanċer.
English: When Bavencio is used with axitinib the most common side effects of the combination, which may affect more than 1 in 5 people, are diarrhoea, high blood pressure, tiredness, nausea, dysphonia (hoarseness), decreased appetite, hypothyroidism (reduced thyroid function), cough, headache, breathing difficulties and arthralgia (joint pain).
Maltese: Meta Bavencio jintuża ma' axitinib l-effetti sekondarji l-aktar komuni tal-kombinazzjoni, li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5, huma dijarea, pressjoni tad-demm għolja, għeja, nawżja, disfonja (ħanqa), nuqqas ta' aptit, ipotirojdiżmu (funzjoni mnaqqsa tat-tirojde), sogħla, uġigħ ta' ras, diffikultajiet fit-teħid tan-nifs u artralġija (uġigħ fil-ġogi).
English: Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain.
Maltese: Effetti sekondarji serji jinkludu reazzjonijiet relatati massistema immunitarja u mal-infużjoni, anemija (għadd baxx ta' ċelloli ħomor tad-demm), diffikultà fitteħid tan-nifs u wġigħ addominali.
English: The side effects of the combination were consistent with what was expected, and were considered acceptable given the nature of the condition being treated.
Maltese: L-effetti sekondarji talkombinazzjoni kienu konsistenti ma' dak li kien mistenni, u tqiesu bħala aċċettabbli meta titqies innatura tal-kundizzjoni li qed tiġi kkurata.
English: As for all medicines, data on the use of Bavencio are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Bavencio hija ssorveljata kontinwament.
English: Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).
Maltese: Bavencio jintuża wkoll flimkien ma' mediċina oħra kontra l-kanċer, axitinib, għall-kura inizjali ta' pazjenti li jkollhom karċinoma taċ-ċellola renali (RCC, kanċer tal-kliewi).
English: The company that markets Bavencio will issue educational materials for patients containing important information about possible side effects of Bavencio, particularly immune-related reactions, and how to manage them.
Maltese: Il-kumpanija li tqiegħed Bavencio fis-suq ser toħroġ materjal edukattiv għall-pazjenti li jinkludi informazzjoni importanti dwar l-effetti sekondarji possibbli ta' Bavencio, b'mod partikolari reazzjonijiet relatati mas-sistema immunitarja, u kif dawn jiġu mmaniġġati.
English: The most common side effects with Bavencio used alone (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Bavencio (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) jinkludu għeja, nawżja (tħossok ma tiflaħx), dijarea, nuqqas ta' aptit, stitikezza, reazzjonijiet relatati ma' infużjoni, tnaqqis fil-piż u remettar.
English: What information is still awaited for Bavencio?
Maltese: Liema informazzjoni għadha mistennija għal Bavencio?
English: What are the risks associated with Bavencio?
Maltese: X'inhuma r-riskji assoċjati ma' Bavencio?
English: Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.
Maltese: Bavencio huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti li jkollhom karċinoma taċ-ċellola Merkel (MCC), tip ta' kanċer tal-ġilda, meta l-kanċer ikun infirex għal partijiet oħra tal-ġisem.
English: Early results from an ongoing study looking at the effects of Bavencio in patients with metastatic MCC who had not received previous chemotherapy showed that the overall response rate at the time of analysis was 62% (18 out of 29 patients).
Maltese: Riżultati bikrija minn studju li għadu għaddej li jħares lejn l-effetti ta' Bavencio f'pazjenti b'MCC metastatika li ma kinux irċevew kimoterapija preċedenti wrew li r-rata ta' rispons ġenerali fiż-żmien tal-analiżi kienet ta' 62 % (18-il pazjent minn 29 pazjent).
English: Since Bavencio has been granted a conditional approval for MCC, the company that markets the medicine will provide further data from the ongoing study of patients who did not receive chemotherapy before starting treatment with Bavencio.
Maltese: Minħabba li Bavencio ngħata approvazzjoni kkundizzjonata, il-kumpanija li tqiegħed il-mediċina fis-suq se tipprovdi aktar data mill-istudju li għadu għaddej tal-pazjenti li ma rċevewx kimoterapija qabel ma bdew il-kura b'Bavencio.
English: Treatment may need to be delayed or stopped if certain side effects occur.
Maltese: Jista' jkun hemm bżonn li l-kura tiġi ttardjata jew titwaqqaf jekk ikun hemm ċerti effetti sekondarji.
English: Before the first 4 infusions of Bavencio, the patient receives an antihistamine and paracetamol to help prevent infusion-related reactions, such as reddening of the skin, chills, fever, back or abdominal (belly) pain, allergic reactions and difficulty breathing.
Maltese: Qabel l-ewwel 4 infużjonijiet ta' Bavencio, il-pazjent jirċievi antistamina u paracetamol biex jgħinu filprevenzjoni ta' reazzjonijiet relatati mal-infużjoni, bħal ħmura tal-ġilda, tertir, deni, uġigħ fid-dahar jew addominali (fiż-żaqq), reazzjonijiet allerġiċi u diffikultà fit-teħid tan-nifs.
English: What measures are being taken to ensure the safe and effective use of Bavencio?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Bavencio?
English: Side effects reported with Bavencio are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Bavencio huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Bavencio has been shown to be of benefit in one main study that showed the cancer shrank in patients with MCC and one that showed patients with RCC could live longer without their disease getting worse.
Maltese: Pazjenti b'MCC li nfirxet u reġgħet feġġet wara kura inizjali bil-kimoterapija għandhom għażliet ta' kura limitati ħafna.
English: For the full list of side effects and restrictions of Bavencio, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Bavencio, ara l-fuljett ta' tagħrif.
English: Bavencio (avelumab)
Maltese: Kif jintuża Bavencio?
English: The safety of Bavencio for this use is considered acceptable and side effects manageable with the additional measures put in place.
Maltese: Is-sigurtà ta' Bavencio għal dan l-użu hija kkunsidrata aċċettabbli u l-effetti sekondarji maniġġabbli bil-miżuri addizzjonali stabbiliti.
English: IRC assessed
Maltese: IRC assessjat
English: Grade ≥3a
Maltese: Grad ≥3a
English: EU/1/16/1138/001 (10 mg, 10 tablets) EU/1/16/1138/002 (10 mg, 14 tablets) EU/1/16/1138/003 (50 mg, 5 tablets) EU/1/16/1138/004 (50 mg, 7 tablets) EU/1/16/1138/005 (100 mg 7 tablets) EU/1/16/1138/006 (100 mg, 14 tablets) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tablets)
Maltese: EU/1/16/1138/001 (10 mg, 10 pilloli) EU/1/16/1138/002 (10 mg, 14 pilloli) EU/1/16/1138/003 (50 mg, 5 pilloli) EU/1/16/1138/004 (50 mg, 7 pilloli) EU/1/16/1138/005 (100 mg 7 pilloli) EU/1/16/1138/006 (100 mg, 14 pilloli) EU/1/16/1138/007 (100 mg, 112 (4 x 28) pilloli)
English: Investigator assessment (N=158)b
Maltese: Valutazzjoni talinvestigatur (N=158)b
English: 10 June 2016
Maltese: 10 Ġunju 2016
English: Frequency (all grades)a
Maltese: Frekwenza (gradi kollha)a
English: Arm B (idelalisib failures) (N=36)
Maltese: (fallimenti ta' idelalisib) (N=36)
English: 24-month PFS estimate (95% CI) CI = confidence interval; NR = not reached aStratified P-value.
Maltese: 12il-xahar stima PFS (95% CI) 24 xahar stima PFS (95% CI) CI = confidence interval; NR = not reached aStratified P-value.
English: MRD negativity rate at end of combination treatmentb
Maltese: MRD rata ta' negattività meta jintemm it-trattament kombinatb
English: The active substance is venetoclax.
Maltese: Is-sustanza attiva hija venetoclax.
English: Venetoclax is not an inhibitor of UGT1A4, UGT1A6, UGT1A9 and UGT2B7.
Maltese: Venetoclax mhuwiex inibitur ta' UGT1A4, UGT1A6, UGT1A9 u UGT2B7.
English: Arm A (ibrutinib failures) (N=91)
Maltese: (fallimenti ta' ibrutinib) (N=91)
English: 17p deletion and/or TP53 mutation status ORR, % (95% CI)
Maltese: Tneħħija ta' 17p u/jew Stat ta' mutazzjoni TP53 ORR,% (95% CI)
English: The risk of TLS is a continuum based on multiple factors, including comorbidities.
Maltese: Ir-riskju tat-TLS huwa kontinwazzjoni abbażi ta' fatturi differenti, inkluż komorbiditajiet.