FrancophonIA/ELRC3.0 huggingface dataset:
English: The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Maltese: Il-potenzjal karċinoġeniku ta' cabozantinib ġie evalwat f'żewġ speċijiet: ġrieden transġeniċi rasH2 u firien Sprague-Dawley.
English: Patients (N=157) with previously untreated, locally advanced or metastatic RCC with a clear cell component were randomized (1:1) to receive CABOMETYX (N=79) or sunitinib (N=78).
Maltese: Pazjenti (N=157) b'RCC avvanzata lokalment jew metastatika li qatt ma ġiet ittrattata qabel b'komponent ta' ċelluli ċari kienu randomized (1:1) biex jirċievu CABOMETYX (N=79) jew sunitinib (N=78).
English: LIST OF EXCIPIENTS Contains lactose.
Maltese: LISTA TA' EĊĊIPJENTI Fih lactose.
English: 1 2-sided stratified log-rank test with etiology of disease (HBV [with or without HCV], HCV [without
Maltese: 1 Test log-rank stratifikat b'2 naħat b'etjoloġija tal-marda (HBV [b'HCV jew mingħajru], HCV [mingħajr
English: Uncommon Not Known
Maltese: Komuni Ħafna
English: Respiratory, thoracic, and mediastinal disorders dysphonia, dyspnoea, cough pulmonary embolism
Maltese: Disturbi respiratorji, toraċiċi u medjastinali disfonja, qtugħ ta' nifs, sogħla emboliżmu pulmonari
English: Child Pugh A: 99%, Child Pugh B: 1 %
Maltese: Stat ta' prestazzjoni (PS - performance status) ta' ECOG ta' 0: 53% jew PS ta' ECOG ta' 1: 47%. Child Pugh A: 99%, Child Pugh B: 1%
English: Fifty-four percent (54%) of patients had 3 or more organs with metastatic disease, including lung (63%), lymph nodes (62%), liver (29%), and bone (22%).
Maltese: Erbgħa u ħamsin (54%) fil-mija talpazjenti kellhom 3 jew aktar organi b'marda metastatika, inklużi l-pulmun (63%), glandoli limfatiċi (62%), fwied (29%), u għadam (22%).
English: In a renal impairment study conducted with a single 60 mg dose of cabozantinib, the ratios of geometric LS mean for plasma cabozantinib, Cmax and AUC0-inf were 19% and 30% higher, for subjects with mild renal impairment (90% CI for Cmax 91.60% to 155.51%; AUC0-inf 98.79% to 171.26%) and 2% and 6-7% higher (90% CI for Cmax 78.64% to 133.52%; AUC0-inf 79.61% to 140.11%), for subjects with moderate renal impairment compared to subjects with normal renal function.
Maltese: 26%) u 2% u 6-7% ogħla (CI ta' 90% għal Cmax 78.64% sa 133.52%; AUC0-inf 79.61% sa 140.11%), għal individwi b'indeboliment moderat tal-kliewi meta mqabbel ma' individwi b'funzjoni tal-kliewi normali.
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Maltese: Cabozantinib kien inibitur (IC50 = 7.0 μM) iżda mhux sottostrat, ta' attivitajiet ta' ġarr tal-glikoproteina P (Pgp - P-glycoprotein) f'sistema ta' assaġġ b'żewġ direzzjonijiet bl-użu ta' ċelluli MDCK-MDR1.
English: In the HCC study (CELESTIAL), hepatic encephalopathy (hepatic encephalopathy, encephalopathy, hyperammonaemic encephalopathy) was reported in 5.6% of cabozantinib-treated patients (26/467); Grade 3-4 events in 2.8%, and one (0.2%) Grade 5 event.
Maltese: Fl-istudju dwar HCC (CELESTIAL), enċefalopatija tal-fwied (enċefalopatija tal-fwied, enċefalopatija, enċefalopatija iperammonimika) kienet irrappurtata f'5.6% tal-pazjenti ttrattati b'cabozantinib (26/467); avvenimenti ta' Grad 3-4 fi 2.8%, u avveniment wieħed (0.2%) ta' Grad 5.
English: Median PFS (95% CI), months HR (95% CI), p-value1
Maltese: PFS medjana (CI ta' 95%), xhur HR (CI ta' 95%), valur p1
English: In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2.
Maltese: Barra minn hekk, cabozantinib jinibixxi tyrosine kinases oħra inkluż ir-riċettur GAS6 (AXL), RET, ROS1, TYRO3, MER, ir-riċettur tal-fattur taċ-ċelluli staminali (KIT), TRKB, tyrosine kinase-3 li jixbħu lil Fms (FLT3
English: Cabozantinib should be discontinued in patients with wound healing complications requiring medical intervention.
Maltese: Cabozantinib għandu jitwaqqaf f'pazjenti b'komplikazzjonijiet fil-fejqan tal-feriti li jeħtieġu intervent mediku.
English: Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Maltese: Reazzjonijiet avversi ta' Grad 4 (minbarra anormalitajiet tal-laboratorju mhux rilevanti klinikament)
English: Events that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia syndrome (PPES), proteinuria, and gastrointestinal (GI) events (abdominal pain, mucosal inflammation, constipation, diarrhoea, vomiting).
Maltese: Avvenimenti li ġeneralment ikollhom bidu bikri jinkludu ipokalċimja, ipokalimja, tromboċitopenija, pressjoni għolja, sindrome ta' eritrodisasteżija palmari-plantari (PPESpalmar-plantar erythrodysaesthesia syndrome), proteina fl-awrina, u avvenimenti gastrointestinali (GIgastrointestinal) (uġigħ addominali, infjammazzjoni tal-mukoża, stitikezza, dijarea, rimettar).
English: Patients (N=707) with HCC not amenable to curative treatment and who had previously received sorafenib for advanced disease were randomized (2:1) to receive CABOMETYX (N=470) or placebo (N=237).
Maltese: Pazjenti (N=707) b'HCC li ma jistgħux jkunusoġġetti għal trattament kurattiv u li kienu rċevew sorafenib fil-passat għal marda avanzata kienu randomised (2:1) biex jirċievu CABOMETYX (N=470) jew plaċebo (N=237).
English: Overall Survival Median OS (95% CI), months HR (95% CI)1,2 p-value1
Maltese: Sopravivenza Globali OS medjana (CI ta' 95%), xhur HR (CI ta' 95%)1,2 valur p1
English: Data for the following reactions are based on patients who received Cabometyx 60 mg qd po in the pivotal studies in RCC following prior VEGF-targeted therapy and in treatment-naïve RCC and in HCC following prior systemic therapy (section 5.1).
Maltese: Data għar-reazzjonijiet li ġejjin hija bbażata fuq pazjenti li rċevew Cabometyx 60 mg qd po fl-istudji pivitali dwar RCC wara terapija preċedenti mmirata lejn VEGF u f'RCC li ma ġietx ittrattata qabel u f'HCC wara terapija sistemika preċedenti (sezzjoni 5.1).
English: Other medicines and CABOMETYX
Maltese: Mediċini oħra u CABOMETYX
English: Effect of other medicinal products on cabozantinib
Maltese: Effett ta' prodotti mediċinali oħra fuq cabozantinib
English: Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
Maltese: XL184-N-oxide, sustanza li tifforma mill-qsim ta' XL184 amide, XL184 monohydroxy sulfate, u s-sulfat li jifforma mill-qsim ta'6-desmethyl amide.
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib (see section 4.5).
Maltese: Individwi għandhom jiġu mwissija dwar it-teħid ta' sottostrat ta' P-gp (eż. fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) waqt li jkunu qed jirċievu cabozantinib (ara sezzjoni 4.5).
English: If adverse reaction does not resolve, permanently discontinue CABOMETYX.
Maltese: Jekk ir-reazzjoni avversa ma tgħaddix, waqqaf CABOMETYX b'mod permanenti.
English: Two non-conjugated metabolites (XL184N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Maltese: Żewġ metaboliti mhux konjugati (XL184-N-oxide u sustanza li tifforma mill-qsim ta' XL184 amide), li għandhom <1% tal-qawwa ta' inibizzjoni ta' kinase fil-mira ta' cabozantinib oriġinali, kull wieħed jirrappreżenta <10% ta' esponiment totali relatat mal-mediċina fil-plażma.
English: Reversible posterior leukoencephalopathy syndrome Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES), has been observed with cabozantinib.
Maltese: Is-Sindrome ta' Lewkoenċefalopatija Riversibbli Posterjuri (RPLS - Reversible Posterior Leukoencephalopathy Syndrome), magħrufa wkoll bħala s-Sindrome ta' Enċefalopatija Posterjuri Riversibbli (PRES - Posterior Reversible Encephalopathy Syndrome), ġiet osservata b'cabozantinib.
English: Figure 3: Kaplan Meier curve for progression-free survival by IRC in treatment-naïve RCC subjects
Maltese: Figura 3: Kurva Kaplan Meier għas-sopravivenza mingħajr progressjoni minn IRC f'individwi b'RCC li ma ngħatawx trattament qabel
English: Objective Response Rate n (%) by Investigator Complete responses
Maltese: Rata ta' Rispons Oġġettiv n (%) mill-Investigatur Rispons sħiħ
English: In the HCC study (CELESTIAL), fistulas were reported in 1.5% (7/467) of the HCC patients.
Maltese: Fl-istudju dwar HCC (CELESTIAL), fistuli kienu rrappurtati f'1.5% (7/467) tal-pazjenti b'HCC.
English: Figure 5: Kaplan Meier curve for progression-free survival (CELESTIAL)
Maltese: Kurva Kaplan Meier għal sopravivenza mingħajr progressjoni (CELESTIAL)
English: A 19% increase in the Cmax of the tablet formulation (CABOMETYX) compared to the capsule formulation (COMETRIQ) was observed.
Maltese: Kienet osservata żieda ta' 19% f'Cmax tal-formulazzjoni talpillola (CABOMETYX) meta mqabbla mal-formulazzjoni tal-kapsula (COMETRIQ).
English: CABOMETYX contains lactose
Maltese: CABOMETYX fih lactose
English: Ipsen NV Guldensporenpark 87
Maltese: België/Belgique/Belgien, Luxembourg/Luxemburg Italia Ipsen NV Guldensporenpark 87
English: Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities)
Maltese: Reazzjonijiet avversi ta' Grad 3 (minbarra anormalitajiet tal-laboratorju mhux rilevanti klinikament)
English: Progression-free survival (PFS)3 Median PFS in months (95% CI) HR (95% CI)1 p-value1
Maltese: Sopravivenza mingħajr progressjoni (PFS)3 PFS medjana f'xhur (CI ta' 95%) HR (CI ta' 95%)1 valur p1
English: Serious gastrointestinal (GI) perforations and fistulas, sometimes fatal, have been observed with cabozantinib.
Maltese: Perforazzjonijiet gastrointestinali (GI - gastrointestinal) u fistuli serji, xi kultant fatali, ġew osservati b'cabozantinib.
English: Hepatic effects Abnormalities of liver function tests (increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with cabozantinib.
Maltese: Anormalitajiet ta' testijiet tal-funzjoni tal-fwied (żidiet fl-alanine aminotransferase [ALT], fl-aspartate aminotransferase [AST] u fil-bilirubina) ġew osservati b'mod frekwenti f'pazjenti ttrattati b'cabozantinib.
English: In the HCC study (CELESTIAL), diarrhoea was reported in 54% of cabozantinib-treated patients (251/467);Grade 3- 4 events in 9.9%.
Maltese: Fl-istudju dwar HCC (CELESTIAL), dijarea kienet irrappurtata f'54% tal-pazjenti ttrattati b'cabozantinib (251/467); avvenimenti ta' Grad 3-4 f'9.9%.
English: • Abscess (collection of pus, with swelling and inflammation)
Maltese: • Axxess (ġabra ta' materja, b'nefħa u infjammazzjoni)
English: Cardiac electrophysiology An increase from baseline in corrected QT interval by Fridericia (QTcF) of 10 - 15 ms on Day 29 (but not on Day 1) following initiation of cabozantinib treatment (at a dose of 140 mg qd) was observed in a controlled clinical study in medullary thyroid cancer patients.
Maltese: Żieda mill-linja bażi fl-intervall QT ikkoreġut minn Fridericia (QTcF - corrected QT interval by Fridericia) ta' 10 - 15 ms f'Jum 29 (iżda mhux f'Jum 1) wara l-bidu tat-trattament b'cabozantinib (b'doża ta' 140 mg qd) kienet osservata fi studju kliniku kkontrollat f'pazjenti b'kanċer tal-medulla tat-tirojde.
English: Secondary efficacy endpoints were objective response rate (ORR) and overall survival (OS).
Maltese: Il-punti finali sekondarji tal-effikaċja kienu r-rata ta' rispons oġġettiv (ORR - objective response rate) u sopravivenza globali (OS - overall survival).
English: The majority of the patients were male (75%), with a median age of 62 years.
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (75%), b'età medjana ta' 62 sena.
English: A higher relative proportion of patients with moderate hepatic impairment (Child-Pugh B) developed hepatic encephalopathy with cabozantinib treatment.
Maltese: Proporzjon relattiv ogħla ta' pazjenti b'indeboliment moderat tal-fwied (Child-Pugh B) żviluppa enċefalopatija tal-fwied bi trattament b'cabozantinib.
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Maltese: Individwi għandhom jiġu mwissija dwar it-teħid ta' sottostrat ta' P-gp (eż., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) waqt li jkunu qed jirċievu cabozantinib.
English: In hepatocellular carcinoma following prior systemic therapy, dose reductions and dose interruptions occurred in 62% and 84%, respectively, of cabozantinib-treated patients in the clinical trial (CELESTIAL).
Maltese: F'karċinoma epatoċellulari wara terapija sistemika preċedenti, tnaqqis fid-doża u interruzzjonijiet fid-doża seħħew fi 62% u 84%, rispettivament, tal-pazjenti ttrattati b'cabozantinib fil-prova klinika (CELESTIAL).
English: Biochemical laboratory test abnormalities
Maltese: Anormalitajiet bijokimiċi tat-test tal-laboratorju
English: CYP3A4 inducers and inhibitors Cabozantinib is a CYP3A4 substrate.
Maltese: Cabozantinib huwa sottostrat ta' CYP3A4.
English: Probability of Survival
Maltese: Probabbiltà ta'Sopravivenza
English: ORR per Investigator Review Intent-To-Treat Population
Maltese: ORR skont Analiżi talinvestigatur ta' Popolazzjoni b'Intenzjoni Li Tiġi Ttrattata
English: Non-disease specific quality of life (QoL) was assessed using the EuroQoL EQ-5D-5L.
Maltese: Il-kwalità tal-ħajja (QoL - quality of life) mhux speċifika għal marda ġiet ivvalutata bl-użu tal-EuroQoL EQ5D-5L.
English: Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Maltese: Cabozantinib ma wera l-ebda potenzjal mutaġeniku jew klastoġeniku f'sensiela standard ta' analiżi ġenotossiċi.
English: CYP3A4 inhibitors and inducers
Maltese: Indutturi u inibituri ta' CYP3A4
English: Proteinuria has been observed with cabozantinib.
Maltese: Proteina fl-awrina ġiet osservata b'cabozantinib.
English: Patients had to have intermediate or poor risk disease as defined by the International Metastatic RCC Database Consortium (IMDC) risk group categories.
Maltese: Il-pazjenti ried ikollhom marda b'riskju intermedju jew baxx kif definit fil-kategoriji tal-gruppi f'riskju tal-Konsorzju Internazzjonali ta' Database ta' RCC Metastatika (IMDC - International Metastatic RCC Database Consortium).
English: In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467).
Maltese: Fl-istudju dwar HCC (CELESTIAL), l-inċidenza ta' avvenimenti emorraġiċi severi (Grad ≥ 3) kienet ta' 7.3% fil-pazjenti ttrattati b'cabozantinib (34/467).
English: ambrisentan, dabigatran etexilate, digoxin, talinolol, and tolvaptan - Medicines for diabetes, such as saxagliptin and sitagliptin - Medicines used to treat gout, such as colchicine - Medicines used to treat HIV or AIDS, such as efavirenz, ritonavir, maraviroc and emtricitabine - Medicines used to prevent transplant rejection (ciclosporin) and ciclosporin-based regimens in rheumatoid arthritis and psoriasis
Maltese: ambrisentan, dabigatran etexilate, digoxin, talinolol, u tolvaptan - Mediċini għad-dijabete, bħal saxagliptin u sitagliptin - Mediċini użati biex jittrattaw il-gotta, bħal colchicine - Mediċini użati biex jittrattaw HIV jew AIDS, bħal efavirenz, ritonavir, maraviroc u emtricitabine - Mediċini użati biex jipprevjenu r-rifjut ta' trapjant (ciclosporin) u korsijiet ibbażati fuq ciclosporin f'artrite rewmatika u psorjasi
English: Table 4: Summary of ORR findings per independent radiology committee review (IRC) and investigator review, in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy
Maltese: Tabella 4: Sommarju ta' sejbiet tar-ORR skont kumitat ta' analiżi radjoloġika indipendenti (IRCindependent review committee) u analiżi tal-investigatur, f'individwi b'RCC wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir tal-endotelju vaskulari (VEGF - vascular endothelial growth factor)
English: Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Maltese: Minħabba l-livelli għolja ta' rbit mal-proteina fil-plażma ta' cabozantinib (sezzjoni 5.2) interazzjoni ta' spostament tal-proteina fil-plażma ma' warfarin tista' tkun possibbli.
English: A statistically significant improvement in PFS as retrospectively assessed by a blinded Independent Radiology Committee (IRC) was demonstrated for CABOMETYX compared to sunitinib (Figure 3 and Table 5).
Maltese: Titjib statistikament sinifikanti fil-PFS kif ivvalutat b'mod retrospettiv minn Kumitat tar-Radjoloġija Indipendenti (IRC - Independent Radiology Committee) blinded intwera għal CABOMETYX meta mqabbel ma' sunitinib (Figura 3 u Tabella 5).
English: Cardiac disorders myocardial infarction
Maltese: Disturbi fil-qalb infart mijokardijaku
English: Progression-free survival (PFS) was assessed by a blinded independent radiology review committee, and the primary analysis was conducted among the first 375 subjects randomized.
Maltese: Sopravivenza mingħajr progressjoni (PFS - Progression-free survival) kienet evalwata minn kumitat ta' analiżi radjoloġika indipendenti u blinded, u l-analiżi primarja saret fost l-ewwel 375 individwu randomised.
English: Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction of CABOMETYX therapy (see Table 1).
Maltese: L-immaniġġjar ta' reazzjonijiet avversi tal-mediċina suspettati jista' jeħtieġ interruzzjoni temporanja tattrattament u/jew tnaqqis fid-doża tat-terapija ta' CABOMETYX (ara Tabella 1).
English: Each carton contains 4 blisters with 28 film-coated tablets.
Maltese: Kull kartuna fiha 4 folji bi 28 pillola miksija b'rita.
English: In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients.
Maltese: Fl-istudju dwar RCC li ma ġietx ittrattata qabel (CABOSUN), perforazzjonijiet GI kienu rrappurtati fi 2.6% (2/78) tal-pazjenti ttrattati b'cabozantinib.
English: In the HCC study (CELESTIAL), GI perforations were reported in 0.9% of cabozantinib-treated patients (4/467).
Maltese: Fl-istudju dwar HCC (CELESTIAL), perforazzjonijiet GI kienu rrappurtati f'0.9% tal-pazjenti ttrattati b'cabozantinib (4/467).
English: Secondary efficacy endpoints were progression-free survival (PFS) and objective response rate (ORR), as assessed by the Investigator using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Maltese: Il-punti finali sekondarji tal-effikaċja kienu s-sopravivenza mingħajr progressjoni (PFS - progression-free survival) u r-rata ta' rispons oġġettiv (ORR - objective response rate), kif ivvalutati mill-Investigatur bl-użu tal-Kriterji talValutazzjoni tar-Rispons f'Tumuri Solidi (RECIST - Response Evaluation Criteria in Solid Tumours) 1.1.
English: CABOMETYX is a cancer medicine that contains the active substance cabozantinib.
Maltese: CABOMETYX huwa mediċina għall-kanċer li fiha s-sustanza attiva cabozantinib.
English: In the treatment-naïve RCC study (CABOSUN), diarrhoea was reported in 73% of cabozantinibtreated patients (57/78);Grade 3-4 events in 10%..
Maltese: Fl-istudju dwar RCC li ma ġietx ittrattata qabel (CABOSUN), dijarea kienet irrappurtata fi 73% tal-pazjenti ttrattati b'cabozantinib (57/78); avvenimenti ta' Grad 3-4 f'10%.
English: The incidence of systemic non-radiation and local liver-directed systemic non-protocol anticancer therapy (NPACT) was 26% in the cabozantinib arm and 33% in the placebo arm.
Maltese: L-inċidenza ta' terapija sistemika mingħajr radjazzjoni u lokali sistemika mmirata lejn il-fwied li mhix skont il-protokoll ta' kontra l-kanċer (NPACT - non-protocol anticancer therapy) kienet ta' 26% fil-grupp ta' cabozantinib u 33% fil-grupp tal-plaċebo.
English: Gastrointestinal disorders diarrhoea, nausea, vomiting, stomatitis, constipation, abdominal pain, dyspepsia, upper abdominal pain gastrointestinal perforation, fistula, gastroesophageal reflux disease, haemorrhoids, oral pain, dry mouth pancreatitis, glossodynia
Maltese: Disturbi gastrointestinali dijarea, dardir, rimettar, stomatite, stitikezza, uġigħ addominali, dispepsja, uġigħ finnaħa ta' fuq taladdome perforazzjoni gastrointestinali, fistula, marda ta' rifluss gastroesofagali, murliti, uġigħ filħalq, ħalq xott pankreatite, glossodinja
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), diarrhoea was reported in 74% of cabozantinib-treated RCC patients (245/331); Grade 3-4 events in 11%.
Maltese: Fl-istudju dwar RCC wara terapija preċedenti mmirata lejn VEGF (METEOR), dijarea kienet irrappurtata f'74% tal-pazjenti b'RCC ittrattati b'cabozantinib (245/331); avvenimenti ta' Grad 3-4 fi 11%.
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma bbażati fuq il-gradi kollha u huma definiti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: A population PK analysis did not identify clinically relevant differences in PK of cabozantinib based on race.
Maltese: Analiżi PK tal-popolazzjoni ma identifikatx differenzi klinikament rilevanti fil-PK ta' cabozantinib bbażi tarrazza.
English: Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
Maltese: L-għoti tal-inibitur qawwi ta' CYP3A4 ketoconazole (400 mg kuljum għal 27 jum) lil voluntiera f'saħħithom naqqas it-tneħħija ta' cabozantinib (b'29%) u żied l-esponiment għal doża waħda ta' cabozantinib fil-plażma (AUC) bi 38%.
English: • Wound complications
Maltese: • Komplikazzjonijiet fil-feriti
English: Mean clearance (CL/F) at steady-state was estimated to be 2.48 L/hr .
Maltese: It-tneħħija medja (CL/F) fi stat fiss kienet stmata bħala 2.48 L/siegħa.
English: Musculoskeletal and connective tissue disorders pain in extremity muscle spasms, arthralgia osteonecrosis of the jaw
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi uġigħ fl-estremitajiet spażmi fil-muskoli, artralġja osteonekrosi taxxedaq
English: In treatment-naïve renal cell carcinoma, dose reductions and dose interruptions occurred in 46% and 73%, respectively, of cabozantinib-treated patients in the clinical trial (CABOSUN).
Maltese: F'karċinoma taċ-ċellula renali li qatt ma ġiet ittrattata qabel, tnaqqis fid-doża u interruzzjonijiet fid-doża seħħew f'46% u 73% rispettivament, tal-pazjenti ttrattati b'cabozantinib fil-prova klinika (CABOSUN).
English: Skin and subcutaneous tissue disorders palmar-plantar erythrodysaesthesia syndrome, rash pruritus, alopecia, dry skin, dermatitis acneiform, hair colour change
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt ilġilda sindrome ta' eritrodisasteżija palmari-plantari, raxx ħakk, alopeċja, ġilda xotta, dermatite blakne, bidla fil-kulur tax-xagħar