FrancophonIA/ELRC3.0 huggingface dataset:
English: Biochemical and metabolic laboratory test abnormalities Stivarga has been associated with an increased incidence of electrolyte abnormalities (including hypophosphatemia, hypocalcaemia, hyponatraemia and hypokalaemia) and metabolic abnormalities (including increases in thyroid stimulating hormone, lipase and amylase).
Maltese: Stivarga kien assoċjat ma' inċidenza akbar ta' anormalitajiet fl-elektroliti (inkluż ipofosfatimija, ipokalċimija, iponatrimija u ipokalimja) u anormalitajiet metaboliċi (inkluż żidiet fl-ormon li jistimola t-tirojde, fil-lipase u fl-amylase).
English: The clinical efficacy and safety of Stivarga have been evaluated in an international, multi-centre, randomised, double-blind, placebo-controlled phase III study (GRID) in patients with gastrointestinal stromal tumours (GIST) previously treated with 2 tyrosine kinase inhibitors (imatinib and sunitinib).
Maltese: L-effikaċja klinika u s-sigurtà ta' Stivarga ġew evalwati fi studju ta' fażi IIII internazzjonali, b'aktar minn ċentru wieħed, randomised, double-blind u kkontrollat bil-plaċebo (GRID) f'pazjenti b'tumuri tal-istroma gastro-intestinali (GIST) li qabel kienu kkurati b'2 inibituri ta' tyrosine kinase (imatinib u sunitinib).
English: Fatal outcome in patients treated with Stivarga was uncommon (0.7%), and included cerebral, respiratory, gastrointestinal and genitourinary events.
Maltese: Riżultat fatali f'pazjenti kkurati b'Stivarga ma kienx komuni (0.7%), u kien jinkludi avvenimenti ċerebrali, respiratorji, gastro-intestinali u ġenitourinarju.
English: Stivarga 40 mg film-coated tablets regorafenib
Maltese: Stivarga 40 mg pilloli miksija b'rita regorafenib
English: In vitro protein binding of regorafenib to human plasma proteins is high (99.5%).
Maltese: In vitro it-twaħħil mal-proteini ta' regorafenib mal-proteini tal-plażma umana huwa għoli (99.5%).
English: Table 4: Treatment-emergent laboratory test abnormalities reported in placebo-controlled phase III trials in patients with metastatic CRC (CORRECT), GIST (GRID) and HCC (RESORCE)
Maltese: III ikkontrollata bil-plaċebo f'pazjenti b'CRC metastatiku (CORRECT), GIST (GRID) u HCC (RESORCE) mCRC (CORRECT)
English: The overall incidence of hand-foot skin reaction (74.8%, CRC, 88.2%, GIST and 67.1%, HCC) was higher in Stivarga-treated Asian patients, compared to other ethnicities.
Maltese: L-inċidenza globali ta' reazzjoni tal-ġilda tal-idejn u s-saqajn (74.8%, CRC, 88.2%, GIST u 67.1%, HCC) kienet ogħla f'pazjenti Asjatiċi kkurati b'Stivarga meta mqabbla ma' razzez oħra.
English: The safety profile of Stivarga plus BSC in the CONCUR study was consistent with the safety profile observed in the CORRECT study.
Maltese: CONCUR kien konsistenti mal-profil tas-sigurtà osservat fl-istudju CORRECT.
English: These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)
Maltese: Dawn jinkludu kimoterapija ibbażata fuq fluoropyrimidine, terapija kontra VEGF u terapija kontra EGFR (ara sezzjoni 5.1).
English: Metabolite M-5 is a weak BCRP-substrate.
Maltese: Il-metabolit M-5 huwa sustrat dgħajjef ta' BCRP.
English: Figure 2: Kaplan-Meier curves of PFS
Maltese: Kaplan-Meier tal-PFS
English: 7.8 months
Maltese: 7.8 xhur
English: In cases of worsening infection events, interruption of Stivarga treatment should be considered.
Maltese: F'każijiet ta' aggravar ta' avvenimenti ta' infezzjoni, għandu jiġi kkunsidrat interruzzjoni tat trattament ta' Stivarga.
English: Parent compound found in faeces could be derived from intestinal degradation of glucuronides or reduction of metabolite M-2 (N-oxide), as well as unabsorbed regorafenib.
Maltese: Il-komponent oriġinali misjub fl-ippurgar jista' jiġi derivat minn degradazzjoni fl-intestini ta' glucuronides jew tnaqqis tal-metabolit M-2 (N-oxide), , kif ukoll minn regorafrnib mhux assorbit.
English: Subgroup analyses for OS and PFS according to age (<65; ≥65), gender, ECOG PS, primary site of disease, time from first diagnosis of metastatic disease, prior anticancer treatment, prior treatment lines for metastatic disease, and KRAS mutation status showed a treatment effect favouring the regorafenib regimen over the placebo regimen.
Maltese: Analiżi tas-sottogrupp għal OS u PFS skont l-età (<65; ≥65), sess, ECOG PS, sit primarja tal-marda, iż-żmien mill-ewwel dijanjosi tal-marda metastatika, kura preċedenti kontra l-kanċer, linji ta' kura preċedenti għall-marda metastatika, u l-istat ta' mutazzjoni KRAS uriet effett tal-kura li jiffavorixxi lkors ta' regorafenib fuq il-kors tal-plaċebo.
English: Gastrointestinal stromal tumours (GIST)
Maltese: Tumuri tal-istroma gastro-intestinali (GIST)
English: Concentration of free thyroxin (FT4) post baseline <LLN was reported in 8.1% of patients treated with Stivarga and 5.6% of patients receiving placebo.
Maltese: Konċentrazzjoni ta' thyroxin ħieles (FT4free thyroxin) <LLN wara l-linja bażi kienet irrappurtata fi 8.1% tal-pazjenti kkurati b'Stivarga u f'5.6% tal-pazjenti li ħadu plaċebo.
English: In addition, regorafenib reduced the levels of tumour associated macrophages and has shown anti-metastatic effects in vivo.
Maltese: Barra dan, regorafenib naqqas il-livelli ta' makrofaġi assoċjati mat-tumur u wera effetti kontra l-metastasi in vivo.
English: In the event of severe bleeding necessitating urgent medical intervention, permanent discontinuation of Stivarga should be considered.
Maltese: F'każ ta' fsada severa li teħtieġ intervent mediku urġenti, għandu jiġi kkunsidrat il-waqfien permanenti ta' Stivarga .
English: Abnormalities of liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and bilirubin) have been frequently observed in patients treated with Stivarga.
Maltese: Anormalitajiet fit-testijiet tal-funzjoni tal-fwied (alanine aminotransferase [ALT], aspartate aminotransferase [AST] u bilirubin) kienu osservati b'mod frekwenti f'pazjenti kkurati b'Stivarga.
English: Nail disorder Erythema multiforme
Maltese: Disturb fiddwiefer Eritema multiforme
English: The highest dose of Stivarga studied clinically was 220 mg per day.
Maltese: L-ogħla doża ta' Stivarga studjata klinikament kienet ta' 220 mg kuljum.
English: Most infections in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 23.0%), and included urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) as well as pneumonia (2.6%).
Maltese: Il-biċċa l-kbira tal-infezzjonijiet f'pazjenti kkurati b'Stivarga kienu ta' severità ħafifa sa moderata (Gradi 1 u 2: 23.0%), u kienu jinkludu infezzjonijiet fl-apparat tal-awrina (5.7%), nażofarinġite (4.0%), infezzjonijiet mukokutanji u infezzjonijiet sistemiċi kkawżati mill-moffa (3.3%) kif ukoll pulmonite
English: - metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies.
Maltese: - kanċer metastatiku tal-kolon u tar-rektum (CRC - colorectal cancer) li kienu kkurati qabel bi, jew li mhumiex ikkunsidrati bħala kandidati għal, terapiji disponibbli.
English: At steady state, regorafenib reaches mean peak plasma levels of about 3.9 mg/L (8.1 micromolar) after oral administration of 160 mg regorafenib and the peak-to-trough ratio of mean plasma concentrations is less than 2.
Maltese: Fi stat fiss, regorafenib jilħaq livelli massimi medji fil plażma ta' madwar 3.9 mg/L (8.1 mikromolari) wara għoti orali ta' 160 mg regorafenib u l-proporzjon tal-konċentrazzjonijiet massimi sa minimi medji fil-plażma huwa inqas minn 2.
English: Increased Amylase a Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 b Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0
Maltese: b Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi (CTCAE - Common Terminology Criteria for Adverse Events), Verżjoni 4.0 * Proporzjon normalizzat internazzjonali
English: • Median duration of sorafenib treatment: 7.8 months
Maltese: • Radjuterapija qabel trattament b'regorafenib: 15% • Tul medjan tat-trattament b'sorafenib: 7.8 xhur
English: The exposure of regorafenib and its metabolites M-2 and M-5 is comparable in patients with mild hepatic impairment (Child-Pugh A) and patients with normal hepatic function.
Maltese: M-2 u M-5 tiegħu huwa komparabbli f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh A) u f'pazjenti b'funzjoni epatika normali.
English: 0.9 months
Maltese: 0.9 xhur
English: In patients with severe renal impairment compared to patients with normal renal function, regorafenib exposure was similar while exposure to M-2 and M-5 was decreased by about 30% under steady-state conditions, which is not considered clinically relevant.
Maltese: F'pazjenti b'indeboliment renali sever meta mqabbla ma' pazjenti b'funzjoni renali normali, l-esponiment għal regorafenib kien simili waqt li l-esponiment għal M-2 u M-5 ġie mnaqqas b'madwar 30% taħt kondizzjonijiet ta' stat fiss, li mhux meqjus klinikament rilevanti.
English: Hyperbilirubinemia
Maltese: Żieda fil-bilirubina
English: Patients with performance status (PS) 2 or higher were excluded from clinical studies.
Maltese: Pazjenti bi stat ta' ħila (PS - performance status) ta' 2 jew aktar kienu esklużi mill-istudji kliniċi.
English: Overall approximately 4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement treatment.
Maltese: B'mod globali madwar 4.6% tal-pazjenti kkurati b'Stivarga żviluppaw ipotirojdiżmu bi ħtieġa ta' kura ta' sostituzzjoni tal-ormoni.
English: In total, 573 patients with HCC were randomised 2:1 to receive either 160 mg regorafenib orally once daily (n=379) plus Best Supportive Care (BSC) or matching placebo (n=194) plus BSC for 3 weeks on therapy followed by 1 week off therapy.
Maltese: B'kollox, 573 pazjent b'HCC kienu randomised 2:1 biex jirċievu regorafenib 160 mg mill-halq darba kuljum (n=379) flimkien mal-Aħjar Kura ta' Appoġġ (BSC - Best Supportive Care) jew plaċebo li jaqbel (n=194) flimkien ma' BSC għal 3 ġimgħat fuq terapija segwit minn ġimgħa waħda bla terapija.
English: Major human metabolites (M-2 and M-5) exhibited similar efficacies, compared to regorafenib in in vitro and in vivo models.
Maltese: Ilmetaboliti maġġuri fil-bniedem (M-2 u M-5) urew effikaċja simili meta mqabbla ma' regorafenib f'mudelli in vitro u f'dawk in vivo.
English: In the placebo-controlled phase III trials, the overall incidence of hand-foot skin reaction was higher in patients treated with Stivarga, compared to patients receiving placebo (all grades: 51.4% vs. 6.5% CRC, 66.7% vs. 15.2% GIST and 51.6% vs.7.3% HCC).
Maltese: III ikkontrollati bil-plaċebo, l-inċidenza globali ta' reazzjoni tal-ġilda tal-idejn u s saqajn kienet ogħla f'pazjenti kkurati b'Stivarga meta mqabbel ma' pazjenti li ħadu plaċebo (gradi kollha: 51.4% vs. 6.5% CRC, 66.7% vs. 15.
English: Stivarga 40 mg tablets are available in packs containing one bottle or three bottles.
Maltese: Pilloli Stivarga 40 mg huma disponibbli f'pakketti li fihom flixkun wieħed jew 3 fliexken.
English: Table 3: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with Stivarga
Maltese: Tabella 3: Reazzjonijiet avversi tal-mediċina (ADRs - Adverse drug reactions) rrappurtati fi provi kliniċi f'pazjenti kkurati b'Stivarga
English: The response rate (complete response or partial response) was 1% and 0.4% for Stivarga and placebo treated patients, respectively (p=0.188432, 1-sided).
Maltese: Ir-rata ta' rispons (rispons komplut jew rispons parzjali) kienet ta' 1% u 0.4% għall-pazjenti kkurati b'Stivarga u bil-plaċebo, rispettivament (p=0.188432, naħa waħda).
English: PFS was significantly longer in patients receiving Stivarga plus BSC (hazard ratio: 0.494, p<0.000001, see Table 5).
Maltese: PFS kienet itwal b'mod sinifikanti f'pazjenti li kienu qed jirċievu Stivarga flimkien ma' BSC (proporzjon ta' periklu: 0.494, p<0.000001, ara Tabella 5).
English: The overall safety profile of Stivarga is based on data from more than 4,800 treated patients in clinical trials including placebo-controlled phase III data for 636 patients with metastatic colorectal cancer (CRC), 132 patients with gastrointestinal stromal tumours (GIST) and 374 patients with hepatocellular carcinoma (HCC).
Maltese: III ikkontrollata bil-plaċebo għal 636 pazjent b'kanċer metastatiku tal-kolon u tar-rektum (CRC), 132 pazjent b'tumuri tal-istroma gastro-intestinali (GIST) u 374 pazjent b'karċinoma epatoċellulari (HCC - hepatocellular carcinoma).
English: Keratoacanthoma/ Squamous cell carcinoma of the skin
Maltese: Kerato akantoma/ Karċinoma taċċellula skwamuża talġilda
English: Increased AST
Maltese: Elevazzjonijiet ta'
English: Most cases of hand-foot skin reaction in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity (Grades 1 and 2: 34.3%%, CRC, 44.7%, GIST and 39.3%, HCC).
Maltese: Il-biċċa l-kbira tal każijiet ta' reazzjoni tal-ġilda tal-idejn u s-saqajn f'pazjenti kkurati b'Stivarga dehru matul l-ewwel ċiklu ta' kura u kienu ta' severità ħafifa sa moderata (Gradi 1 u 2: 34.3%, CRC, 44.7%, GIST u 39.3%,
English: Hypothyroidism
Maltese: Ipokalċimija
English: The mean daily regorafenib dose received was 144 mg.
Maltese: Id-doża medja ta' kuljum ta' regorafenib riċevuta kienet 144 mg.
English: Stivarga 40 mg film-coated tablets.
Maltese: Stivarga 40 mg pilloli miksija b'rita.
English: Thrombocytopenia Anaemia
Maltese: Trombo ċitopenija
English: Hand-foot skin reaction (HFSR) or palmar-plantar erythrodysesthesia syndrome and rash represent the most frequently observed dermatological adverse reactions with Stivarga (see section 4.8).
Maltese: Reazzjoni tal-ġilda tal-idejn u s-saqajn HFSR - hand-foot skin reaction) jew sindrome ta' eritrodisestesija palmari-plantari u raxx jirrappreżentaw l-aktar reazzjonijiet avversi dermatoloġiċi osservati b'mod frekwenti b'Stivarga (ara sezzjoni 4.8).
English: Treatment-emergent laboratory abnormalities observed in the placebo-controlled phase III trials are shown in Table 4 and Table 4a (see also section 4.4).
Maltese: III ikkontrollati bil-plaċebo huma mniżżla f'Tabella 4 u Tabella 4a (ara wkoll sezzjoni 4.4).
English: The addition of Stivarga to BSC resulted in significantly longer survival, compared to placebo plus BSC with a p value of 0.005178 from stratified log rank test, a hazard ratio of 0.774 [95% CI 0.636, 0.942] ) and a median OS of 6.4 months vs. 5.0 months (see Table 5 and Figure 1).
Maltese: Iż-żieda ta' Stivarga ma' BSC wasslet għal sopravivenza sinifikatament itwal meta mqabbel mal plaċebo flimkien ma' BSC b'valur p ta' 0.005178 minn test log rank stratifikat, proporzjon ta' periklu ta' 0.774 [95% CI 0.636, 0.942] u OS medjana ta' 6.4 xhur kontra 5.0 xhur (ara Tabella 5 u Figura 1).
English: Across all clinical trials, cardiac disorder events (all grades) have been more often (13.7% vs. 6.5%) reported in Stivarga-treated patients aged 75 years or older (N=410), compared to Stivarga-treated patients below 75 years (N=4108).
Maltese: Fil-provi kliniċi kollha, avvenimenti ta' disturbi fil-qalb (gradi kollha) kienu rrappurtati b'mod aktar frekwenti (13.7% kontra 6.5%) f'pazjenti kkurati b'Stivarga b'età ta' 75 sena jew aktar (N=410), meta mqabbel ma' pazjenti kkurati b'Stivarga b'età inqas minn 75 sena (N=4108).
English: Regorafenib plus BSC resulted in significantly longer PFS, compared to placebo plus BSC with a hazard ratio of 0.268 [95% CI 0.185, 0.388] and a median PFS of 4.8 months vs. 0.9 months (p < 0.000001).
Maltese: Regorafenib flimkien ma' BSC wassal għal PFS itwal b'mod sinifikanti meta mqabbel mal-plaċebo flimkien ma' BSC bi proporzjon ta' periklu ta' 0.268 [CI ta' 95% 0.185, 0.388] u PFS medjana ta' 4.8 xhur kontra 0.9 xhur (p < 0.000001).
English: PS ≥ 2 receiving placebo (8.3%).
Maltese: 2%), bl-aktar notevoli epistassi (6.1%).
English: M-2 is further metabolised by oxidative metabolism mediated by CYP3A4, as well as by glucuronidation mediated by UGT1A9.
Maltese: M-2 huwa metabolizzat aktar permezz ta' metaboliżmu ossidattiv medjat minn CYP3A4, kif ukoll minn glukuronidazzjoni medjata minn UGT1A9.
English: In the placebo-controlled phase III trials, tests on thyroid stimulating hormone (TSH) showed post baseline >ULN in 34.6% of patients treated with Stivarga and in 17.2% of patients receiving placebo.
Maltese: III ikkontrollati bil-plaċebo, testijiet dwar l-ormon li jistimula t-tirojde (TSHthyroid-stimulating hormone) urew livell ta' > ULN wara l-linja bażi f'34.6% tal-pazjenti kkurati b'Stivarga u fi 17.2% tal-pazjenti li ħadu plaċebo.
English: 4.8 months
Maltese: 4.8 xhur
English: - hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Maltese: - karċinoma epatoċellulari (HCC - hepatocellular carcinoma) li kienet ittrattata minn qabel b'sorafenib.
English: Rare side effects (may affect up to 1 in 1,000 users)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa utent wieħed minn kull 1,000)
English: Approximately 90% of the radioactive dose was recovered within 12 days after administration, with about 71% of the dose excreted in faeces (47% as parent compound, 24% as metabolites), and about 19% of the dose excreted in urine as glucuronides.
Maltese: Madwar 90% tad-doża radjuattiva kienet irkuprata fi żmien 12-il jum wara l-għoti, b'madwar 71% taddoża mneħħija fl-ippurgar (47% bħala mediċina mhux mibdula, 24% bħala metaboliti), u madwar 19% tad-doża mneħħija fl-awrina bħala glucuronides.
English: TSH post baseline >4 times ULN was reported in 6.5% of patients treated with Stivarga and in 1.3% of patients receiving placebo.
Maltese: TSH ta' > 4 darbiet ULN wara l-linja bażi kienet irrappurtata f'6.5% tal-pazjenti kkurati b'Stivarga u f'1.3% tal-pazjenti li ħadu plaċebo.
English: Available clinical data indicate similar exposure of regorafenib and its metabolites M-2 and M-5 in patients with mild, moderate or severe renal impairment compared to patients with normal renal function.
Maltese: Dejta klinika disponibbli tindika esponiment simili għal regorafenib u l-metaboliti tiegħu M-2 u M-5 f'pazjenti b'indeboliment renali ħafif, moderat jew sever meta mqabbel ma' pazjenti b'funzjoni renali normali.
English: Pack of 28 film-coated tablets.
Maltese: Pakkett ta' 28 pillola miksija b'rita.
English: It is recommended to avoid concomitant use of strong inhibitors of CYP3A4 activity (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin and voriconazole) as their influence on the steady-state exposure of regorafenib and its metabolites has not been studied.
Maltese: (eż. clarithromycin, meraq tal-grejpfrut, itraconazole, ketoconazole, posaconazole, telithromycin u voriconazole) peress li l-influwenza tagħhom fuq l esponiment fi stat fiss għal regorafenib ma ġietx studjata.
English: Most cases of hypertension in patients treated with Stivarga appeared during the first cycle of treatment and were mild to moderate in severity (Grades 1 and 2: 20.9%, CRC, 31.8%, GIST and 15.8% HCC).
Maltese: Il-biċċa l-kbira tal-każijiet ta' pressjoni għolja f'pazjenti kkurati b'Stivarga dehru matul l-ewwel ċiklu ta' kura u kienu ta' severità ħafifa sa moderata (Gradi 1 u 2: 20.9%, CRC, 31.8%, GIST u 15.
English: Regorafenib, M-2 and M-5 are likely to undergo enterohepatic circulation (see section 5.2).
Maltese: Regorafenib, M-2 u M-5 x'aktarx li jgħaddu miċ-ċirkolazzjoni enteroepatika (ara sezzjoni 5.2).
English: The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Stivarga (41.0% vs. 14.9%, p<0.000001, 1 sided).
Maltese: Id-DCR (rispons komplut jew rispons parzjali jew marda stabbli) kienet ogħla b'mod sinifikanti f'pazjenti kkurati b'Stivarga (41.0% kontra 14.9%, p<0.000001, naħa waħda).
English: This medicine contains 55.8 mg sodium (main component of cooking/table salt) in each daily dose (4 tablets).
Maltese: Din il-mediċina fiha 55.8 mg ta' sodium (il-komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'kull doża ta' kuljum (4 pilloli).
English: The mean daily regorafenib dose received was 147 mg.
Maltese: Id-doża medja ta' kuljum ta' regorafenib kienet ta' 147 mg.
English: Stivarga has been associated with an increased incidence of myocardial ischaemia and infarction (see section 4.8).
Maltese: Iskemija u infart kardijaku Stivarga kien assoċjat ma' inċidenza akbar ta' iskemija u infart mijokardijaku (ara sezzjoni 4.8).
English: Interrupt therapy for a minimum of 7 days until toxicity resolves to Grade 0-1.
Maltese: Waqqaf it-terapija għal minimu ta' 7 ijiem, sakemm it-tossiċità titjieb għal Grad 0-1.
English: TTP was significantly longer in patients receiving regorafenib plus BSC than in patients receiving placebo plus BSC with a hazard ratio of 0.248 [95% CI 0.170, 0.364], and median TTP of 5.4 months vs. 0.9 months (p<0.000001) (see Table 6).
Maltese: TTP kien itwal b'mod sinifikanti f'pazjenti li rċevew regorafenib flimkien ma' BSC milli f'pazjenti li ħadu plaċebo flimkien ma' BSC bi proporzjon ta' periklu ta' 0.248 [CI ta' 95 % 0.170, 0.364], u TTP medjan ta' 5.4 xhur vs. 0.9 xhur (p < 0.000001) (ara t-Tabella 6).
English: There are no data for patients with Child-Pugh C (severe) hepatic impairment.
Maltese: M'hemmx dejta għall-pazjenti b'indeboliment epatiku Child-Pugh Ċ (sever).
English: The primary efficacy endpoint was Overall Survival (OS).
Maltese: Il-punt finali primarju tal-effikaċja kien is-Sopravivenza Globali (OS - Overall Survival).
English: In the placebo-controlled phase III trials, the overall incidence of treatment emergent proteinuria was 9.1% in patients treated with Stivarga, compared to 1.9% in patients receiving placebo.
Maltese: III ikkontrollati bil-plaċebo, l-inċidenza globali ta' proteina fl-awrina li ħarġet mattrattament kienet ta' 9.1% f'pazjenti trattati b'Stivarga, meta mqabbel ma' 1.9% f'pazjenti li jirċievu plaċebo.
English: Breast cancer resistance protein (BCRP) and P-glycoprotein substrates Administration of regorafenib (160 mg for 14 days) prior to administration of a single dose of rosuvastatin (5 mg), a BCRP substrate, resulted in a 3.8-fold increase in mean exposure (AUC) of rosuvastatin and a 4.6-fold increase in Cmax.
Maltese: L-għoti ta' regorafenib (160 mg għal 14-il ġurnata) qabel l-għoti ta' doża waħda ta' rosuvastatin (5 mg), sustrat ta' BCRP, wassal għal żieda ta' 3.8 darbiet fl-espożizzjoni medja (AUC) ta' rosuvastatin u żieda ta' 4.6 darbiet f'Cmax.
English: Cardiac electrophysiology/QT prolongation
Maltese: Elettrofiżjoloġija tal-qalb/titwil ta' QT
English: After repeated dosing to mice, rats and dogs, adverse effects were observed in a number of organs, primarily in the kidneys, liver, digestive tract, thyroid gland, lympho-/haematopoietic system, endocrine system, reproductive system and skin.
Maltese: Wara dożaġġ ripetut lill-ġrieden, firien u klieb, effetti avversi kienu osservati f'numru ta' organi, primarjament fil-kliewi, fwied, apparat diġestiv, glandola tat-tirojde, sistema limfo-/ematopoetika,
English: Stivarga plus BSC§ (N=136)
Maltese: Stivarga (N=133) Plaċebo (N=66)
English: This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 3% tal-konsum massimu ta' sodium kuljum rakkomandat għal adult.
English: Patients with unstable angina or new onset angina (within 3 months of starting Stivarga therapy), recent myocardial infarction (within 6 months of starting Stivarga therapy) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher were excluded from the clinical studies.
Maltese: terapija b'Stivarga), infart mijokardijaku reċenti (fi żmien 6 xhur mill-bidu ta' terapija b'Stivarga) u dawk b'insuffiċjenza kardijaka Klassifika 2 jew ogħla tal-Assoċjazzjoni tal-Qalb ta' New York (NYHA - New York Heart Association) ġew esklużi mill-istudji kliniċi.
English: Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER' on one side and ‘40' on the other side.
Maltese: Pilloli miksija b'rita roża ċari, b'forma ovali, b'tul ta' 16-il mm u wisa' ta' 7 mm immarkati b'‘BAYER' fuq naħa u ‘40' fuq in-naħa l-oħra.