FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal impairment is unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites (see section 5.2).
Maltese: Indeboliment renali mhux probabbli li jkollu effett kliniku relevanti fuq il-farmakokinetiċi ta' pazopanib minħabba l-eliminazzjoni renali baxxa ta' pazopanib u metaboliti (ara sezzjoni 5.2).
English: Cardiac dysfunction g
Maltese: Disfunzjoni talqalb g
English: P value (two-sided)
Maltese: Valur p (b'żewġ naħat)
English: Table 6 Overall efficacy results in STS by independent assessment (VEG110727)
Maltese: Tabella 6 Riżultati tal-effikaċja globali f'STS permess ta' valutazzjoni indipendenti (VEG110727)
English: ‘Other STS' subgroups
Maltese: Sottogruppi oħra ta' ‘STS'
English: Results from population pharmacokinetic modelling (data from subjects with baseline CLCR values ranging from 30.8 ml/min to 150 ml/min) indicated that renal impairment is unlikely to have clinically relevant effect on pazopanib pharmacokinetics.
Maltese: Riżultati minn mudellar farmakokinetiku ta' populazzjoni, data minn suġġetti b'valuri CLCR linja bażi li jvarjaw min 30.8 ml/min sa 150 ml/min) tindika illi l-indeboliment renali mhux mistenni li jħalli effett kliniku relevanti fuq il-farmakokinetika ta' pazopanib.
English: Votrient is not recommended for people aged under 18.
Maltese: Votrient mhux irrakkomandat għal persuni b'età inqas minn 18-il sena.
English: Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family (e.g. itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase pazopanib concentrations.
Maltese: L-għoti ta' pazopanib flimkien ma' inibituri potenti oħra tal-familja tal-CYP3A4 (eż. itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) jista' jwassal għal żieda fil-konċentrazzjonijiet tal-pazopanib.
English: Potential induction of human CYP3A4 was demonstrated in an in vitro human PXR assay.
Maltese: L-induzzjoni potenzjali ta' CYP3A4 uman kien muri f'assaġġ in vitro ta' PXR uman.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali urew tossiċità riproduttiva (ara sezzjoni 5.3).
English: Figure 4 Kaplan-Meier Curve for progression-free survival by independent assessment for the overall population (VEG108844)
Maltese: Kaplan-Meier għas-sopravivenza mingħajr progressjoni minn valutazzjoni indipendenti tal-popolazzjoni globali (VEG108844)
English: Uncommon Thrombotic microangiopathy (including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome)
Maltese: Mhux komuni Mikroanġjopatija trombotika (inkluż purpura tromboċitopenika trombotika u sindrome uremiku emolitiku) †
English: Demographic characteristics were similar between the treatment arms.
Maltese: Il-karatteristiċi demografiċi kienu simili bejn il-gruppi ta' kura.
English: Pazopanib is eliminated slowly with a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg.
Maltese: Pazopanib huwa eliminat bil-mod b'half-life medja ta' 30.9 sigħat wara l-għoti tad-doża rakkomandata ta'800 mg.
English: The following convention has been utilised for the classification of frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: In preclinical experiments, pazopanib dose-dependently inhibited ligand-induced auto-phosphorylation of VEGFR-2, c-Kit and PDGFR- receptors in cells.
Maltese: F'esperimenti qabel il-fażi klinika, pazopanib stimula, skont id-doża, il ligand-induced auto-phosphorylation ta' riċetturi VEGFR-2, c-Kit u PDGFR- fiċ-ċelloli.
English: Uncommon Pancreatitis Rectal haemorrhage 8 (<1%) Haematochezia
Maltese: Mhux komuni Pankrejatite Emorraġija fir-rektum 8 (<1%) Ematokeżja
English: Similar proportions of patients in each arm had prior nephrectomy (89% and 88% in the pazopanib and placebo arms, respectively) and/or prior radiotherapy (22% and 15% in the pazopanib and placebo arms, respectively.
Maltese: Proporzjonijiet simili ta' pazjenti f'kull driegħ kellhom nefrektomija minn qabel (89% u 88% fiddirgħajn tal-pazopanib u placebo, rispettivament) u/jew radjuterapija (22% u 15% fid-dirgħajn talpazopanib u l-placebo, rispettivament).
English: All grades n (%)
Maltese: Gradi kollha n (%)
English: In clinical studies with pazopanib, myocardial infarction, myocardial ischaemia, ischaemic stroke and transient ischaemic attack were observed (see section 4.8).
Maltese: Fi studji kliniċi b'pazopanib, infart mijokardjali, iskemija mijokardjali, puplesija iskemika u attaki iskemiċi li jgħaddu, kienu osservati (ara sezzjoni 4.8).
English: Common Peripheral sensory neuropathy
Maltese: Newropatija periferali sensorjali Sturdament
English: In a randomised study comparing pazopanib and sunitinib in RCC (VEG108844), subjects had baseline and follow up LVEF measurements.
Maltese: Fi studju randomizzat li jqabbel pazopanib u sunitinib f'RCC (VEG108844), l-individwi kellhom kejl fil-linja bażi u LVEF ta' segwitu.
English: Pazopanib resulted in an increase of approximately 30% in the mean AUC and Cmax of midazolam (CYP3A4 probe substrate) and increases of 33% to 64% in the ratio of dextrometrophan to dextrophan concentrations in the urine after oral administration of dextromethorphan (CYP2D6 probe substrate).
Maltese: Il-pazopanib rriżulta f'żieda ta' madwar 30% fil-medja tal-AUC u l-Cmax ta' midazolam (sustanza sonda li fuqha taġixxi l-CYP3A4) u żidiet ta' 33% sa 64% fil-proporzjon tal-konċentrazzjoni bejn dextrometrophan u dextrophan fl-awrina wara l-użu orali ta' dextromethorphan (sustanza sonda li fuqha taġixxi l-CYP2D6).
English: Grade 3 fatigue (dose-limiting toxicity) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg and 1000 mg daily, respectively.
Maltese: Għeja ta' Grad 3 (effett tossiku li jillimita d-doża) u pressjoni għolja ta' Grad 3 kienu t-tnejn osservati f'1 minn 3 pazjenti li ngħataw doża ta' 2000 mg u 1000 mg kuljum, rispettivament.
English: OS = overall survival * Overall survival for the respective STS histological subgroups (leiomyosarcoma, synovial sarcoma and “Other” STS) should be interpreted with caution due to the small number of subjects and wide confidence intervals
Maltese: OS = sopravivenza totali * Sopravivenza totali għas-sottogruppi istoloġiċi rispettivi ta' STS (lejomajosarkoma, sarkoma sinovjali u STS “Oħra”) għandha tiġi interpretata b'attenzjoni minħabba n-numru żgħir ta' individwi u intervalli to kunfidenza wiesgħa.
English: The 95% confidence intervals for all subgroups include a hazard ratio of 1.
Maltese: L-intervalli ta' kunfidenza ta' 95% għal kull sottogrupp jinkludu proporzjon ta' periklu ta' 1.
English: Patients were stratified by the factors of WHO performance status (WHO PS) (0 or 1) at baseline and the number of lines of prior systemic therapy for advanced disease (0 or 1 vs. 2+).
Maltese: Pazjenti kienu stratifikati skont il-fatturi tal-istat ta' prestazzjoni WHO (WHO PS) (0 jew 1) fil-linja bażi u n-numru ta' linji ta' terapija sistemika minn qabel għall-marda avanzata (0 jew 1 kontra 2+).
English: Categories have been assigned based on absolute frequencies in the clinical trial data.
Maltese: Kull kategorija ġiet mwaqqfa fuq bażi ta' frekwenzi assoluti mill-informazzjoni tal-provi kliniċi.
English: Effects included reduced female fertility, increased pre- and post-implantation loss, early resorptions, embryo lethality, decreased foetal body weight and cardiovascular malformation.
Maltese: Effetti inkludew tnaqqis fil-fertilità femminili, żiediet fit-telf qabel u wara l-implantazzjoni, riassorbimenti bikrija, mewt embrijonali, tnaqqis fil-piż tal-ġisem tal-fetu, u formazzjoni difettuża kardjovaskulari.
English: Binding of pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10-100 g/ml.
Maltese: L-irbit ta' pazopanib ma' proteina fil-plażma umana in vivo kien aktar minn 99% mingħajr l-ebda dipendenza tal-konċentrazzjoni ‘il barra mill-firxa ta' bejn l-10-100 g/ml.
English: Pharmacogenomics
Maltese: Farmakoġenomika
English: No significant difference in OS was observed between the two treatment arms at the final OS analysis performed after 76% (280/369) of the events had occurred (HR 0.87, 95% CI 0.67, 1.12 p=0.256).
Maltese: Ma kienet osservata l-ebda differenza sinfikanti f'OS bejn iż-żewġ gruppi ta' kura fl-analiżi finali ta' OS li saret wara li seħħew 76% (280/369) tal-avvenimenti (HR 0.87, 95% CI 0.67, 1.12 p=0.256).
English: ILD, which can be fatal, has been reported in association with pazopanib (see section 4.8).
Maltese: ILD, li jista' jkun fatali, kien irrapportat f'assoċjazzjoni ma' pazopanib (ara sezzjoni 4.8).
English: Special populations
Maltese: Eritema plantari
English: A total of 369 patients with advanced STS were randomised to receive pazopanib 800 mg once daily or placebo.
Maltese: Total ta' 369 pazjent b'STS avanzata kienu randomised biex jirċievu pazopanib 800 mg darba kuljum jew plaċebo.
English: Pazopanib is a UGT1A1 inhibitor.
Maltese: Pazopanib huwa inibitur ta' UGT1A1.
English: The median overall survival (OS) data at the protocol-specified final survival analysis were 22.9 months and 20.5 months [HR = 0.91 (95% CI: 0.71, 1.16; p = 0.224)] for patients randomised to the pazopanib and placebo arms, respectively.
Maltese: Id-dejta ta' sopravivenza globali (OS) medjana fl-analiżi tas-sopravivenza finali speċifikata millprotokoll kienet ta' 22.9 xhur u 20.5 xhur [HR = 0.91 (95% CI: 0.71, 1.16; p = 0.224)] għall-pazjenti randomized għall-gruppi ta' pazopanib u plaċebo, rispettivament.
English: Muscle spasms
Maltese: Emorraġija esofagali
English: Normal hepatic function
Maltese: Funzjoni epatika normali
English: Other medicines and Votrient
Maltese: Mediċini oħra u Votrient
English: Table 2 Treatment-related adverse reactions reported in RCC studies (n = 1149) or during post-marketing period
Maltese: Tabella 2 Reazzjonijiet avversi relatati mal-kura rrappurtati fl-istudji dwar RCC (n = 1149)
English: Pazopanib doses up to 2000 mg have been evaluated in clinical studies.
Maltese: Dożi ta' pazopanib sal-2000 mg ġew evalwati fi studji kliniċi.
English: Synovial sarcoma subgroups
Maltese: Sottogruppi ta' sarkoma sinovjali
English: VEG108844 achieved its primary endpoint of PFS and demonstrated that pazopanib was non-inferior to sunitinib, as the upper bound of the 95% CI for the hazard ratio was less than the protocol-specified non-inferiority margin of 1.25.
Maltese: VEG108844 laħaq il-punt finali primarju tiegħu ta' PFS u wera li pazopanib ma kienx inferjuri għal sunitinib, peress li l-ogħla limitu ta' 95% CI għall-proporzjon ta' periklu kien inqas mill-marġini ta' nuqqas ta' inferjorità speċifikat fil-protokoll ta' 1.25.
English: Laboratory abnormalities were reported as adverse events less frequently by investigators than as indicated by laboratory value tables.
Maltese: Anormalitajiet tal-laboratorju kienu rrappurtati bħala avvenimenti avversi inqas frekwenti mill-investigaturi milli kif indikat minn tabelli talvalur tal-laboratorju.
English: Common Alopecia Skin disorder c
Maltese: Alopeċja Disturb fil-ġilda c
English: Interstitial lung disease (ILD)/Pneumonitis
Maltese: Mard interstizjali tal-pulmun (ILD)/pnewmonite
English: In vivo, pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in various animal models, and the growth of multiple human tumour xenografts in mice.
Maltese: pazopanib inibita l-VEGF-induced VEGFR-2 phosphorylation ġol-pulmuni tal-ġrieden, anġjoġenesi f'diversi mudelli t'annimali, u t-tkattir ta' xenografts multipli ta' tumuri umani fil-ġrieden.
English: Pooled data from the pivotal STS study (VEG110727, n=369) and the supportive Phase II study (VEG20002, n=142) was evaluated in the overall evaluation of safety and tolerability of pazopanib (total safety population n=382) in subjects with STS (see section 5.1).
Maltese: II (VEG20002, n = 142) kienet evalwata fil-valutazzjoni globali ta' sigurtà u tollerabilità ta' pazopanib (popolazzjoni ta' sigurtà totali n = 382) f'individwi b'STS (ara sezzjoni 5.1).
English: Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to pazopanib (see section 4.5).
Maltese: Trattament flimkien ma' indutturi ta'CYP3A4 għandu jiġi evitat minħabba r-riskju ta'esponiment anqas għal pazopanib (ara sezzjoni 4.5).
English: Effects of pazopanib on other medicinal products
Maltese: Effetti ta' pazopanib fuq prodotti mediċinali oħra
English: Uncommon Retinal detachment† 1 (<1%) Retinal tear†
Maltese: 1 (<1%) Tiċrita retinali†
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għall-bnedmin mhuwiex magħruf.
English: Uncommon Gingival infection 1 (<1%) Infectious peritonitis 1 (<1%)
Maltese: Mhux komuni Infezzjoni fil-ħanek 1 (<1%) Peritonite b'infezzjoni 1 (<1%)
English: Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma, malignant solitary fibrous tumours), so-called fibrohistiocytic (pleomorphic malignant fibrous histiocytoma [MFH], giant cell MFH, inflammatory MFH), leiomyosarcoma, malignant glomus tumours, skeletal muscles (pleomorphic and alveolar rhabdomyosarcoma), vascular (epithelioid hemangioendothelioma, angiosarcoma), uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, PEComa, intimal sarcoma), malignant peripheral nerve sheath tumours, undifferentiated soft tissue sarcomas not otherwise specified (NOS) and other types of sarcoma (not listed as ineligible).
Maltese: [MFH], MFH taċ-ċellula ġiganta, MFH infjammatorja), lejomijosarkoma, tumuri glomus malinni, muskolu skeletriċi (rabdomijosarkoma pleomorfika u alveolari), vaskulari (emanġjoendoteljoma tal-epitilju, anġjosarkoma), divrenzjar mhux ċert (sinovjali, tal-epitilju, alveolari tal-parti r-ratba, ċelluli ċari, taċ-ċelluli desmoplastiċi żgħar tondi, rabdojd ekstra renali, mesenkinoma malinna, PEComa, sarkoma intima), tumuri malinni tal-kisja tan-nervituri periferali, sarkomi tat-tessut l-artab mhux diffrenzjati u mhux speċifikati mod ieħor (NOS) u tipi oħra ta' sarkoma (mhux elenkat bħala mhux eliġibbli).
English: Results from a meta-analysis using pooled data from clinical studies with pazopanib show that ALT >3x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of simvastatin (p = 0.038).
Maltese: Riżultati minn meta-analiżi bl-użu ta' dejta miġbura minn studji kliniċi b'pazopanib juru li ALT >3x ULN kien irrappurtat f'126/895 (14%) tal-pazjenti li ma użawx statins, meta mqabbel ma' 11/41 (27%) talpazjenti li użaw simvastatin fl-istess waqt (p = 0.038).
English: x axis; Months, y axis; Proportion Progression Free, Pazopanib --- (N = 135) Median 7.4 months; Placebo -------- (N = 67) Median 4.2 months; Hazard Ratio = 0.54, 95% CI (0.35, 0.84), P <0.001
Maltese: x axis; Xhur, y axis; Proporzjon Ħielsa mill-Progressjoni, Pazopanib --- (N = 135) Medja 7.4 xhur; Plaċebo -------- (N = 67) Medjan 4.2 xhur; Proporzjon ta' Periklu = 0.54, 95% CI (0.35, 0.84), P <0.001
English: Prior anthracycline therapy may be a risk factor for cardiac dysfunction.
Maltese: Terapija minn qabel b'anthracycline tista' tkun fattur ta' riskju għal disfunzjoni tal-qalb.
English: See Table 1 for dose modification guidance for patients with baseline values of total bilirubin 1.5 x ULN and AST and ALT 2 x ULN:
Maltese: Ara Tabella 1 għal gwida dwar il-modifika tad-doża għal pazjenti li jkollhom valuri ta' bilirubina totali fil-linja bażi ta' 1.5 x ULN u AST u ALT ta' 2 x ULN:
English: The most important serious adverse reactions identified in the RCC or STS studies were transient ischaemic attack, ischaemic stroke, myocardial ischaemia, myocardial and cerebral infarction, cardiac dysfunction, gastrointestinal perforation and fistula, QT prolongation, Torsade de Pointes and pulmonary, gastrointestinal and cerebral haemorrhage, all adverse reactions being reported in <1% of treated patients.
Maltese: L-aktar reazzjonijiet avversi importanti identifikati fl-istudji dwar RCC jew STS kienu attakk iskemiku li jgħaddi, puplesija iskemika, iskemija mijokardjali, infart mijokardijaku u ċerebrali, disfunzjoni tal-qalb, perforazzjoni gastrointestinali u fistula, titwil tal-intervall QT, Torsade de Pointes u emorraġija respiratorji, gastrointestinali u tal-moħħ, bir-reazzjonijiet avversi kollha rrappurtati f'<1% ta'pazjenti fuq kura.
English: - The other ingredients in the 200 mg and 400 mg tablets are: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone (K30), sodium starch glycolate, titanium dioxide (E171).
Maltese: macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone (K30),
English: Aspartate aminotransferase Alanine aminotransferase Platelet count decreased
Maltese: Komuni ħafna Żieda f'alanine aminotransferase Żieda f'aspartate aminotransferase
English: Cerebral infarction 1 (<1%)
Maltese: Fistula enterokutanja 1 (<1%) Ematemesi
English: Photosensitivity reaction
Maltese: Reazzjoni ta' fotosensittività
English: The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Maltese: Il-maġġoranza tal-pazjenti kellhom fatturi pronjostiċi MSKCC (Memorial Sloan Kettering Cancer Centre) /Motzer jew favorevoli (39%) jew intermedji (54%).
English: x axis; Months, y axis; Proportion Progression Free, Pazopanib --- (N = 155) Median 11.1 months; Placebo -------- (N = 78) Median 2.8 months; Hazard Ratio = 0.40, 95% CI (0.27, 0.60), P <0.0000001
Maltese: x axis; Xhur, y axis; Proporzjon Ħielsa mill-Progressjoni, Pazopanib --- (N = 155) Medja 11.1-il xahar; Plaċebo -------- (N = 78) Medjan 2.8 xhur; Proporzjon ta' Periklu = 0.40, 95% CI (0.27, 0.60), P <0.
English: Common Musculoskeletal pain 35 (9%) Myalgia Muscle spasms Uncommon Arthralgia
Maltese: Spażmi fil-muskoli 8 (2%) 0 Mhux komuni Artralġja
English: In clinical studies with pazopanib, venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred.
Maltese: Fi studji kliniċi b'pazopanib, seħħew avvenimenti tromboemboliċi venużi inkluż trombożi fil-vini u embolu fatali fil-pulmun.
English: The maximally tolerated pazopanib dose (MTD) in patients with moderate hepatic impairment (defined as an elevation of bilirubin >1.5 x to 3 x ULN regardless of the ALT values) was 200 mg once daily.
Maltese: Id-doża massima ttollerata ta' pazopanib (MTD) f'pazjenti b'indeboliment epatiku moderat (definit bħala elevazzjoni ta' bilirubin ta' >1.5 x sa 3 x ULN indipendenti mill-valuri tal-ALT) kienet ta' 200 mg darba kuljum.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensitività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Pazopanib has been shown to be embryotoxic and teratogenic when administered to rats and rabbits at exposures more than 300-fold lower than the human exposure (based on AUC).
Maltese: Pazopanib ġie muri li huwa embrijotossiku u teratoġeniku meta amministrat lill-ġrieden u fniek f'esponimenti ta' iżjed minn 300-darba inqas mill-esponiment uman (ibbażat fuq AUC).
English: Hot flush Venous thromboembolic event g
Maltese: Avveniment tromboemboliku venuż d
English: Transaminase elevations >3 x ULN concurrently with bilirubin elevations >2 x ULN
Maltese: Żidiet fit-transaminases ta' >3 x ULN fl-istess ħin ma' żidiet fil-bilirubina ta' >2 x ULN
English: Gastrointestinal (GI) perforations and fistula
Maltese: Perforazzjoni gastro-intestinali (GI) u fistula
English: Upon oral administration of a single pazopanib 800 mg dose to patients with solid tumours, maximum plasma concentration (Cmax) of approximately 19 ± 13 µg/ml was obtained after median 3.5 hours (range 1.0-11.9 hours) and an AUC0-∞ of approximately 650 ± 500 µg.h/ml was obtained.
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 800 mg pazopanib lil pazjenti b'tumuri solidi, ntleħqu konċentrazzjonijiet massimi fil-plażma (Cmax) ta' madwar 19 ± 13 µg/ml wara medjan ta' 3.5 sigħat (jvarjaw bejn 1.0-11.9 sigħat) u AUC0-∞ ta'madwar 650 ± 500 µg.h/ml.
English: Of note, patients with adipocytic sarcoma were excluded from the pivotal Phase III study as in a preliminary Phase II study (VEG20002) activity (PFS at week 12) observed with pazopanib in adipocytic did not meet the prerequisite rate to allow further clinical testing.
Maltese: III peress li fi studju preliminari ta' fażi II (VEG20002), l-attività (PFS f'ġimgħa 12) osservata b'pazopanib f'sarkoma adipoċitika ma ssodisfatx ir-rata meħtieġa minn qabel biex tippermetti aktar ittestjar kliniku.
English: Figure 5 Kaplan-Meier Curve for Progression-Free Survival in STS by Independent Assessment for the Overall Population (VEG110727)
Maltese: Kaplan-Meier għal Sopravivenza Mingħajr Progressjoni f'STS minn Valutazzjoni Indipendenti għall-Popolazzjoni Globali (VEG110727)
English: The efficacy and safety of pazopanib in STS were evaluated in a pivotal Phase III randomised, double-blind, placebo-controlled multicentre study (VEG110727).
Maltese: III, randomised, double-blind, ikkontrollat bil-plaċebo u b'aktar minn ċentru wieħed (VEG110727).
English: Rash vesicular
Maltese: Raxx makulari
English: Enterocutaneous fistula
Maltese: Fistula enterokutanja
English: The most common adverse reactions (experienced by at least 10% of the patients) of any grade in the RCC and STS trials included: diarrhoea, hair colour change, skin hypopigmentation, exfoliative rash, hypertension, nausea, headache, fatigue, anorexia, vomiting, dysgeusia, stomatitis, weight decreased, pain, elevated alanine aminotransferase and elevated aspartate aminotransferase.
Maltese: L-aktar reazzjonijiet avversi komuni (li nħassu minn mhux anqas min 10% tal-pazjenti) f'kull grad filprovi dwar RCC u STS inkludew: dijarrea, tibdil fil-kulur tax-xagħar, ipopigmentazzjoni tal-ġilda, raxx bil-qxur, pressjoni għolja, tqalligħ, uġigħ ta' ras, għeja, anoressja, rimettar, disgewżja, stomatite, tnaqqis fil-piż, uġigħ u levelli ogħla ta' alanine aminotransferase u aspartate aminotransferase.
English: Interstitial lung disease/pneumonitis†
Maltese: Mard interstizjali tal-pulmun /pnewmonite†
English: A similar proportion of patients in each arm were treatment-naïve and cytokine pre-treated (53% and 47% in pazopanib arm, 54% and 46% in placebo arm).
Maltese: Proporzjon simili ta' pazjenti f'kull driegħ tat-trattament kienu inġenwu għat-trattament u trattati minn qabel b'ċitokini (53% u 47% fid-driegħ tal-pazopanib, 54% u 46% fid-driegħ tal-placebo).
English: Cerebrovascular accident
Maltese: Infart ċerebrali
English: Concomitant treatment with strong inhibitors of CYP3A4, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib (see section 4.5).
Maltese: Trattament flimkien ma' inibituri potenti ta' CYP3A4, P-glycoprotein (P-gp) jew protejini ta' reżiżtenza tal-kanċer tas-sider (BCRP) għandu jiġu evitati minħabba r-riskju ta' esponiment ogħla għall-pazopanib (ara sezzjoni 4.5).
English: Uncommon Hypomagnesaemia 10 (<1%) 0
Maltese: Deidratazzjoni Mhux komuni Ipomagnesimja 1 (<1%) 0