FrancophonIA/ELRC3.0 huggingface dataset:
English: Across clinical studies in which 1,327 patients received lenvatinib monotherapy in indications other than HCC, Grade ≥ 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.2%) had a Grade 4 haemorrhage and 8 patients (0.6%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial haemorrhage, intracranial tumour haemorrhage, haematemesis, melaena, haemoptysis and tumour haemorrhage.
Maltese: Fl-istudji kliniċi kollha li fihom 1,327 pazjent irċevew kura b'monoterapija ta' lenvatinib għal indikazzjonijiet li ma kinux HCC, emorraġija ta' Grad ≥ 3 jew aktar ġiet irrappurtata fi 2% talpazjenti, 3 pazjenti (0.2%) kellhom emorraġija ta' Grad 4, u 8 pazjenti (0.6%) kellhom reazzjoni ta' Grad 5 li tinkludi emorraġija arterjali, aċċessjoni emorraġika, emorraġija intrakranjali, emorraġija minn tumur intrakranjali, ematemesi, melaena, emoptisi u emorraġija tat-tumur.
English: • Uncommon (≥1/1,000 to <1/100)
Maltese: • Komuni ħafna (>1/10)
English: Non-Gastrointestinal fistulae (see section 4.4)
Maltese: Perforazzjoni gastrointestinali u l-formazzjoni ta' fistula (ara sezzjoni 4.4)
English: In the Phase 3 REFLECT trial (see section 5.1), QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), titwil tal-intervall tal-QT/QTc ġie rrappurtat f'6.9% tal-pazjenti ttratti b'lenvatinib.
English: However, in vivo data indicated that non-P450-mediated pathways contributed to a significant portion of the overall metabolism of lenvatinib.
Maltese: Madankollu, dejta in vivo indikat li passaġġi mhux medjati minn P450 ikkontribwew għal porzjon sinifikanti tal-metaboliżmu globali ta' lenvatinib.
English: Gastrointestinal perforation and fistula formation (see section 4.4)
Maltese: Fistuli mhux gastrointestinali (ara sezzjoni 4.4)
English: The capsules must be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to dissolve the capsule shells.
Maltese: Il-kapsuli għandhom jitħallew fil-likwidu għal mill-inqas 10 minuti u jitħawdu għal mill-inqas 3 minuti biex jinħallu l-qxur tal-kapsuli.
English: Amongst 1,166 patients treated with lenvatinib, there were 3 cases (0.3%) of hepatic failure, all with a fatal outcome.
Maltese: Fost 1,166 pazjent li ġew ittratti b'lenvatinib, kien hemm 3 każijiet (0.3%) ta' insuffiċjenza tal-fwied, kollha b'riżultat fatali.
English: In the Phase 3 REFLECT trial (see section 5.1), arterial thromboembolic events were reported in 2.3% of patients treated with lenvatinib.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), avvenimenti ta' tromboemboliżmi arterjali ġew irrappurtati fi 2.3% tal-pazjenti ttratti b'lenvatinib.
English: Hepatic failure and acute hepatitis (<1%; see section 4.8, Description of selected adverse reactions) have been reported in patients with DTC treated with lenvatinib.
Maltese: Insuffiċjenza tal-fwied u epatite akuta (<1%; ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula) ġew irrappurtati f'pazjenti b'DTC ittratti b'lenvatinib.
English: Non-GI fistula
Maltese: Perforazzjoni GI jew fistula
English: In patients, the median apparent volume of distribution (Vz/F) of the first dose ranged from 50.5 L to 92 L and was generally consistent across the dose groups from 3.2 mg to 32 mg.
Maltese: Fil-pazjenti, il-volum apparenti medjan tad-distribuzzjoni (Vz/F) tal-ewwel doża varja minn 50.5 L sa 92 L u kien ġeneralment konsistenti fil-gruppi kollha tad-doża minn 3.2 mg sa 32 mg.
English: Stratified by region (Europe vs. North America vs. Other), age group (≤65 years vs >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).
Maltese: >65 sena), u terapija mmirata VEGF/VEGFR fil-passat (0 vs. 1).
English: Adverse reactions that most commonly led to dose modifications (in ≥5% of patients) were decreased appetite, diarrhoea, proteinuria, hypertension, fatigue, PPE and decreased platelet count.
Maltese: Reazzjonijiet avversi li bl-aktar mod komuni wasslu għal tnaqqis fid-doża (f'≥5% tal-pazjenti) kienu pressjoni għolja, proteinurija, dijarea, għeja, PPE, tnaqqis fil-piż, u tnaqqis fl-aptit.
English: LENVIMA 4 mg hard capsules
Maltese: LENVIMA 4 mg kapsuli ibsin
English: In vitro binding of lenvatinib to human plasma proteins is high and ranged from 98% to 99% (0.3 - 30 μg/mL, mesylate).
Maltese: It-twaħħil in vitro ta' lenvatinib mal-proteini tal-plażma tal-bniedem hu għoli, u kien ivarja minn 98% sa 99% (0.3 - 30 μg/mL, mesilate).
English: Hepatic encephalopathyl,‡,†
Maltese: Enċefalopatija talfwiedl,‡,†
English: There are not sufficient data for HCC patients with Child-Pugh B (moderate hepatic impairment, 3 patients treated with lenvima in the pivotal trial) and no data available in Child Pugh C HCC patients (severe hepatic impairment).
Maltese: M'hemmx dejta suffiċjenti għal pazjenti b'HCC b'Child-Pugh B (indeboliment tal-fwied moderat, 3 pazjenti ttratti b'lenvima fil-prova importanti ħafna) u l-ebda dejta disponibbli għal-pazjenti b'HCC b'Child Pugh C (indeboliment tal-fwied sever).
English: The primary risk factor identified was dehydration and/or hypovolemia due to gastrointestinal toxicity.
Maltese: Il-fattur ta' riskju primarju identifikat kienet deidratazzjoni u/jew ipovolemija minħabba tossiċità gastrointestinali.
English: In the Phase 3 REFLECT trial (see section 5.1), diarrhoea was reported in 38.7% of patients treated with lenvatinib (4.2% were Grade ≥ 3).
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), dijarea ġiet irrappurtata fi 38.7% tal-pazjenti ttratti b'lenvatinib (4.2% kienu ta' Grad ≥ 3).
English: Estimated using the Kaplan-Meier method; the 95% CI was constructed with a generalised Brookmeyer and Crowley method in patients with a best overall response of complete response or partial response.
Maltese: Stima bl-użu tal-metodu Kaplan-Meier; in-95% Cl inbena b'metodu Brookmeyer u Crowley ġeneralizzat f'pazjenti bl-aħjar rispons globali ta' rispons komplet jew rispons parzjali.
English: Do not take LENVIMA if:
Maltese: Tiħux LENVIMA jekk:
English: In the Phase 3 REFLECT trial (see section 5.1), haemorrhage was reported in 24.6% of patients and 5.0% were Grade ≥ 3.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), emorraġija ġiet irrappurtata f'24.6% tal-pazjenti u 5.0% kienu ta' Grad ≥ 3.
English: Uncommon Not known
Maltese: Komuni Ħafna
English: The pharmacokinetics of lenvatinib following a single 10-mg dose were evaluated in 6 subjects each with mild and moderate hepatic impairment (Child-Pugh A and Child-Pugh B, respectively).
Maltese: Il-farmakokinetika ta' lenvatinib wara doża waħda ta' 10 mg ġiet evalwata f'6 individwi, li kull wieħed minnhom kellu indeboliment ħafif u moderat tal-fwied (Child-Pugh A u Child-Pugh B, rispettivament).
English: In the Phase 3 REFLECT trial (see section 5.1), cardiac dysfunction (including congestive cardiac failure, cardiogenic shock, and cardiopulmonary failure) was reported in 0.6% of patients (0.4% were Grade ≥ 3) in the lenvatinib-treated group.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), disfunzjoni kardijaka (inkluż insuffiċjenza konġestiva tal-qalb, xokk kardjoġeniku, u insuffiċjenza kardjopulmonari) kienet irrappurtata f'0.6% tal-pazjenti (0.4% kienu ta' Grad ≥ 3) fil-grupp ttratt b'levantinib.
English: The results for surrogate endpoints (PFS and ORR) are presented in Table 7 below.
Maltese: Ir-riżultati għall-punti aħħarin surrogate (PFS u ORR) huma ppreżentati f'Tabella 7 hawn taħt.
English: Growth retardation, secondary delay of physical development, and lesions attributable to pharmacologic effects (incisors, femur [epiphyseal growth plate], kidneys, adrenals, and duodenum) were also observed in juvenile rats.
Maltese: Dewmien fit-tkabbir, dewmien sekondarju tal-iżvilupp fiżiku, u leżjonijiet attribwibbli għal effetti farmakoloġiċi (incisors, femur [plates tat-tkabbir epiphyseal], kliewi, adrenali, u duwodenu) ġew osservati wkoll fil-firien ġuvenili.
English: Proteinuria led to permanent treatment discontinuation in 0.8% of patients.
Maltese: Il-proteinurija wasslet għal twaqqif permanenti tal-kura f'0.8% talpazjenti.
English: A haemorrhage event led to dose interruption or reduction in 3.2% and 0.8% patients respectively and to treatment discontinuation in 1.7% of patients.
Maltese: Avveniment ta' emorraġija wassal għal interruzzjoni jew tnaqqis fid-doża fi 3.2% u 0.8% tal-pazjenti rispettivament, u għall-waqfien permanenti tal-kura f'1.7% talpazjenti.
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Maltese: Meta BP sistolika tkun ta' ≤150 mmHg, BP dijastolika ta' ≤95 mmHg, u l-pazjent kien fuq doża stabbli ta' terapija kontra l-pressjoni għolja għal mill-inqas 48 siegħa, kompli lenvatinib f'doża mnaqqsa (ara sezzjoni 4.2).
English: Impairment of thyroid stimulating hormone suppression/ Thyroid dysfunction
Maltese: Indeboliment ta' soppressjoni tal-ormon li jistimula t-tirojde/Disfunzjoni tat-tirojde
English: Reduce dose in succession based on the previous dose level (12 mg, 8 mg, 4 mg or 4 mg every other day).
Maltese: Naqqas id-doża suċċessivament abbażi tal-livell tad-doża preċedenti (12 mg, 8 mg, 4 mg jew 4 mg jum iva, jum le).
English: The majority of cases recovered following dose interruption or reduction, which occurred in 6.9% and 2.5% of patients respectively.
Maltese: Il-maġġoranza tal-każijiet irkupraw wara interruzzjoni jew tnaqqis taddoża, li seħħew f'6.9% u 2.5% tal-pazjenti, rispettivament.
English: Men had a higher incidence (26.5%) of dysphonia than women (12.3%), decreased weight and decreased platelet count.
Maltese: L-irġiel kellhom inċidenza ogħla (26.5%) ta' disfonija min-nisa (12.3%), tnaqqis fil-piż u tnaqqis fl-għadd ta' plejtlits.
English: Non-Gastrointestinal fistula
Maltese: Fistula mhux gastrointestinali
English: Amongst 1,823 patients treated with lenvatinib monotherapy in clinical trials, there were 5 cases (0.3%) of PRES (0.2% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Maltese: Fost 1,823 pazjent ttratti b'monoterapija ta' lenvatinib fil-provi kliniċi, kien hemm 5 każijiet (0.3%) ta' PRES (0.2% kienu ta' Grad 3 jew 4), li kollha fiequ wara l-kura/jew interruzzjoni tad-doża, jew twaqqif permanenti.
English: Progression-Free Survival (PFS)a Number of progressions or deaths (%) Median PFS in months (95% CI)
Maltese: Sopravivenza Ħielsa mill-Progressjoni (PFS)a Numru ta' progressjonijiet jew imwiet (%) PFS medjan f'xhur (95% CI)
English: Randomisation was stratified by geographic region (Europe, North America, and Other), prior VEGF/VEGFR-targeted therapy (patients may have received 0 or 1 prior VEGF/VEGFR-targeted therapy), and age (≤65 years or >65 years).
Maltese: L-għażla b'mod każwali ġiet stratifikata skont ir-reġjun ġeografiku (Ewropa, Amerika, u Oħrajn), terapija mmirata VEGF/VEGFR fil-passat (il-pazjenti setgħu kienu rċivew 0 jew 1 terapija mmirata VEGF/VEGFR fil-passat), u età (≤65 sena jew >65 sena).
English: Mortality was the dose-limiting toxicity in juvenile rats in which dosing was initiated on postnatal day (PND) 7 or PND21 and was observed at exposures that were respectively 125- or 12-fold lower compared with the exposure at which mortality was observed in adult rats, suggesting an increasing sensitivity to toxicity with decreasing age.
Maltese: Il-mortalità kienet it-tossiċità li tillimita d-doża f'firien ġuvenili li fihom, id-dożaġġ inbeda f'jum wara t-twelid (PND - postnatal day) 7 jew PND21, u ġiet osservata f'esponimenti li kienu rispettivament 125 jew 12-il darba aktar baxxi meta mqabbla mal-esponiment li fih il-mortalità ġiet osservata f'firien adulti, li jissuġġerixxi sensittività dejjem tiżdied għat-tossiċità b'età dejjem tonqos.
English: Cerebrovascular accident †
Maltese: Inċident ċerebrovaskulari †
English: Includes cases with a fatal outcome.
Maltese: Tinkludi każijiet b'riżultat fatali.
English: Hazard ratio (95% CI)b,c
Maltese: Proporzjon ta' periklu (95% CI)b,ċ
English: Elevation of TSH above the upper limit of normal was observed post baseline in 69.6% of lenvatinib-treated patients.
Maltese: L-għoli ta' TSH aktar 'il fuq mil-limitu ta' fuq tannormal kien osservat wara l-linja bażi f'69.6% tal-pazjenti ttratti b'levantinib.
English: Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
Maltese: Lenvatinib jindebbolixxi s-soppressjoni esoġena tat-tirojde (ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib
Maltese: LENVIMA 4 mg kapsuli ibsin LENVIMA10 mg kapsuli ibsin lenvatinib
English: In 496 patients with HCC, dose modification (interruption or reduction) and discontinuation were the actions taken for an adverse reaction in 62.3% and 20.2% of patients, respectively.
Maltese: F'496 pazjent b'HCC, modifikazzjoni (interruzzjoni jew tnaqqis) u t-twaqqif tad-doża kienu lazzjonijiet meħuda għal reazzjoni avversa fi 62.3% u 20.
English: Patients who had received 1 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Maltese: Pazjenti li fil-passat irċivew 1 terapija mmirata VEGF/VEGFR (%) Numru ta' progressjonijiet jew imwiet PFS medjan f'xhur (95% CI)
English: Persistent and Intolerable Grade 2 or Grade 3 Toxicitiesa Adverse Reaction Modification
Maltese: Tossiċitajiet Persistenti u Intollerabbli ta' Grad 2 jew Grad 3a Reazzjoni
English: INFORMATION IN BRAILLE LENVIMA 4 mg
Maltese: LENVIMA 4 mg
English: Slovenská republika Eisai GesmbH organizační složka Tel.: +420 242 485 839 (Česká republika)
Maltese: +420 242 485 839 (Česká republika)
English: Lenvatinib was embryotoxic and teratogenic when administered to rats and rabbits (see section 5.3).
Maltese: Lenvatinib kien embrijotossiku u teratoġeniku meta ngħata lil firien u l-fniek (ara sezzjoni 5.3).
English: LENVIMA 10 mg hard capsules
Maltese: Lenvima 10 mg kapsuli ibsin
English: Other medicines and LENVIMA
Maltese: Mediċini oħra u LENVIMA
English: In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group.
Maltese: Fil-prova ta' Fażi 3 REFLECT (ara sezzjoni 5.1), kien hemm avveniment wieħed ta' PRES (Grad 2) fil-grupp ttratt b'lenvatinib.
English: In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite.
Maltese: F'mikrosomi tal-fwied tal-bniedem, il-forma demethylated ta' lenvatinib (M2) ġiet identifikata bħala lmetabolit ewlieni.
English: Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged QT, hypothyroidism, hyponatraemia, increased blood thyroid stimulating hormone, pneumonia compared with subjects with normal renal function.
Maltese: Pazjenti b'indeboliment tal-kliewi fil-linja bażi kellhom inċidenza ogħla ta' pressjoni għolja ta' Grad 3 jew 4, proteinurija, għeja, stomatite, edema periferali, tromboċitopenija, deidratazzjoni, QT imtawwal , ipotirojdiżmu, iponatremija, żieda fl-ormon li jistimula t-tirojde tad-demm, pnewmonja meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives.
Maltese: Bħalissa mhux magħruf jekk lenvatinib iżidx ir-riskju ta' avvenimenti tromboemboliċi meta kkombinat ma' kontraċettivi orali.
English: Patients who had received 0 prior VEGF/VEGFR-targeted therapy (%) Number of progressions or deaths Median PFS in months (95% CI)
Maltese: Pazjenti li fil-passat irċivew 0 terapija mmirata VEGF/VEGFR (%) Numru ta' progressjonijiet jew imwiet PFS medjan f'xhur (95% CI)
English: Oral inflammation includes: aphthous stomatitis, aphthous ulcer, gingival erosion, gingival ulceration, oral mucosal blistering, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Maltese: Infjammazzjoni orali tinkludi: stomatite aftuża, ulċera aftuża, erożjoni ġinġivali, ulċerazzjoni ġinġivali, infafet tal-mukoża tal-ħalq, stomatite, glossite, ulċerazzjoni fil-ħalq, u infjammazzjoni mukożali.
English: Patients of age ≥75 years were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness, malaise, peripheral oedema, pruritus and hepatic encephalopathy.
Maltese: Pazjenti li kellhom ≥75 sena kienu aktar probabbli li jesperjenzaw pressjoni għolja, proteinurija, tnaqqis fl-aptit, astenija, deidrazzjoni, sturdament, telqa, edema periferali, ħakk u enċefalopatija talfwied.
English: In DTC, liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin.
Maltese: F'DTC, reazzjonijiet avversi relatati mal-fwied, l-aktar irrappurtati b'mod komuni f'pazjenti ttratti b'lenvatinib, kienu jinkludu żidiet f'alanine aminotransferase (ALT), f'aspartate aminotransferase (AST), u fil-bilirubina fid-demm.
English: However, testicular (hypocellularity of the seminiferous epithelium) and ovarian changes (follicular atresia) were observed in repeated-dose toxicity studies in animals at exposures 11 to 15 times (rat) or 0.6 to 7 times (monkey) the anticipated clinical exposure (based on AUC) at the maximum tolerated human dose.
Maltese: Madankollu, ġie osservat tibdil testikulari (ipoċellularità tal-epitelju seminiferu) u tibdil fl-ovarji (atreżija follikulari) fi studji dwar it-tossiċità b'dożi ripetuti f'annimali f'esponimenti ta' 11 sa 15-il darba (firien) jew 0.6 sa 7 darbiet (xadini) tal-esponiment kliniku antiċipat (ibbażat fuq l-AUC) fiddoża massima ttollerata fil-bniedem.
English: The main efficacy outcome measure was progression-free survival (PFS) as determined by blinded independent radiologic review using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Maltese: Il-kejl ewlieni tar-riżultat taleffikaċja kienet sopravivenza mingħajr progressjoni (PFS) kif determinat mill-reviżjoni radjoloġika indipendenti blinded bl-użu tal-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST = Response Evaluation in Solid Tumors) 1.1.
English: • other types of fistulae (an abnormal connection between different organs in the body or between the skin and an underlying structure such as throat and windpipe).
Maltese: • tipi oħrajn ta' fistuli (konnessjoni mhux normali bejn organi differenti fil-ġisem jew bejn ilġilda u struttura sottostanti bħal griżmejn u l-passaġġ tan-nifs).
English: Discontinue lenvatinib and institute appropriate medical management.
Maltese: Waqqaf lenvatinib u ibda mmaniġġjar mediku adattat.
English: Hepatic failurek,‡,†
Maltese: Insuffiċjenza tal fwiedk,‡,†
English: This binding was mainly to albumin with minor binding to α1-acid glycoprotein and γ-globulin.
Maltese: Dan it-twaħħil kien l-aktar mal-albumina, bi twaħħil minuri ma' α1-acid glycoprotein u γ-globulin.
English: In total, 954 patients were randomised 1:1 to receive either lenvatinib (12 mg [baseline body weight ≥60 kg] or 8 mg [baseline body weight <60 kg]) given orally once daily or sorafenib 400 mg given orally twice daily.
Maltese: B'kollox, 954 pazjent intgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew lenvatinib (12 mg [piż tal-ġisem fil-linja bażi ta' ≥60 kg] jew 8 mg [piż tal-ġisem fil-linja bażi ta' <60 kg]) mogħti mill-ħalq darba kuljum, jew sorafenib 400 mg mogħti mill-ħalq darbtejn kuljum.
English: LENVIMA
Maltese: Koleċistite
English: Eight healthy, demographically matched subjects served as controls and received a 10-mg dose.
Maltese: Tmien individwi b'saħħithom, li ġew imqabbla demografikament, servew bħala kontrolli u rċivew doża ta' 10 mg.
English: Hazard ratio (95% CI)b, e P-value b, e
Maltese: Proporzjon ta' periklu (95% CI)b, e
English: Haemorrhage terms that occurred in 5 or more subjects with DTC were: epistaxis, haemoptysis, haematuria, contusion, haematochezia, gingival bleeding, petechial, pulmonary haemorrhage, rectal haemorrhage, blood urine present, haematoma and vaginal haemorrhage.
Maltese: It-termini tal-emorraġija li seħħew f'5 individwi jew aktar b'DTC kienu: epistassi, emoptisi, ematurija, kontużjoni, ematokeżija, ħruġ ta' demm mill-ħanek, tikek żgħar vjola fuq il-ġilda, emorraġija pulmonari, emorraġija mir-rektum, demm preżenti fl-awrina, ematoma u emorraġija vaġinali.
English: In the Phase 3 REFLECT trial (see section 5.1), events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), ġew irrappurtati avvenimenti ta' perforazzjoni gastrointestinali jew fistula f'1.9% tal-pazjenti ttratti b'lenvatinib.
English: The available very limited data are not sufficient to allow for a dosing recommendation for HCC patients with moderate hepatic impairment (Child-Pugh B).
Maltese: Id-dejta limitata ħafna disponibbli mhijiex suffiċjenti biex tippermetti rakkomandazzjoni ta' dożaġġ għall-pazjenti b'HCC b'indeboliment tal-fwied moderat (Child-Pugh B).
English: Stratified by region (Region 1: Asia-Pacific; Region 2: Western), macroscopic portal vein invasion or extrahepatic spread or both (yes, no), ECOG PS (0, 1) and body weight (<60 kg, ≥60 kg).
Maltese: Reġjun 2: Punent), invażjoni makroskopika tal-vina portali jew firxa barra mill-fwied jew it-tnejn (iva, le), ECOG PS (0, 1) u piż tal-ġisem
English: Grade 3 reactions occurred in 3.4%, Grade 4 reactions in 0.2% and 7 patients (1.5%) had a grade 5 reaction including cerebral haemorrhage, upper gastrointestinal haemorrhage, intestinal haemorrhage and tumour haemorrhage.
Maltese: Reazzjonijiet ta' Grad 3 seħħew fi 3.4%, reazzjonijiet ta' Grad 4 f'0.2%, u 7 pazjenti (1.5%) kellhom reazzjoni ta' Grad 5 inkluż emorraġija ċerebrali, emorraġija gastrointestinali tan-naħa ta' fuq, emorraġija intestinali u emorraġija tat-tumur.
English: Hepatic failure (including fatal events in 12 patients) occurred in 3.6% of patients (all were ≥ Grade 3).
Maltese: Insuffiċjenza tal-fwied (inkluż avvenimenti fatali fi 12-il pazjent) seħħet fi 3.6% tal-pazjenti (kollha kienu ta' ≥ Grad 3).
English: In the pivotal Phase 3 SELECT trial (see section 5.1), arterial thromboembolic events were reported in 5.4% of lenvatinib-treated patients and 2.3% of patients in the placebo group.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), avvenimenti ta' tromboemboliżmi arterjali ġew irrappurtati f'5.4% tal-pazjenti ttratti b'lenvatinib u fi 2.3% tal-pazjenti fil-grupp talplaċebo.
English: • anal fistula (a small channel that forms between the anus and the surrounding skin)
Maltese: • fistula anali (kanal żgħir li jifforma bejn l-anus u l-ġilda tal-madwar)
English: In the sorafenib arm, median OS was 17.0 months (95% CI: 14.2, 18.8) for subjects who received posttreatment anticancer therapy (51%) and 7.9 months (95% CI: 6.6, 9.7) for those who did not.
Maltese: Fil-fergħa talistudju dwar sorafenib, l-OS medjan kien ta' 17.0 xhur (95% CI: 14.2, 18.8) għal individwi li rċevew terapija ta' kontra l-kanċer wara l-kura (51%) u ta' 7.9 xhur (95% CI: 6.6, 9.7) għal dawk li ma rċevewhiex.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), proteinuria was reported in 33.7% of lenvatinibtreated patients and 3.1% of patients in the placebo-treated group.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), proteinurija ġiet irrappurtata fi 33.7% tal-pazjenti ttratti b'lenvatinib u fi 3.1% tal-pazjenti fil-grupp li kien qed jiġi ttratt bi plaċebo.
English: Four (1.5%) subjects treated with lenvatinib attained a CR and 165 subjects (63.2%) had a PR, while no subjects treated with placebo had a CR and 2 (1.5%) subjects had a PR.
Maltese: Erba' (1.5%) individwi li ġew ttratti b'lenvatinib kisbu CR u 165 individwi (63.2%) kellhom PR, filwaqt li l-ebda individwu li ġie ttratt bilplaċebo ma kellu CR u 2 (1.5%) individwi kellhom PR.
English: QT interval prolongation
Maltese: Titwil tal-intervall tal-QT