FrancophonIA/ELRC3.0 huggingface dataset:
English: Contains macrogolglycerol hydroxystearate and ethanol anhydrous.
Maltese: Fih macrogolglycerol hydroxystearate u ethanol anhydrous.
English: Acute respiratory distress syndrome
Maltese: Sindromu ta' distress respiratorju akut
English: Midostaurin has a tissue distribution of geometric mean of 95.2 l (Vz/F).
Maltese: Midostaurin għandu distribuzzjoni fit-tessuti b'medja ġeometrika ta' 95.2 l (Vz/F).
English: Cumulative incidence of relapse (CIR)
Maltese: Inċidenza kumulattiva ta' rikaduta (CIR)
English: This is equivalent to 8.4 ml beer or 3.5 ml wine.
Maltese: Dan hu ekwivalenti għal 8.4 ml ta' birra jew 3.5 ml inbid.
English: The mean AUClast of CGP52421 decreased by 60%.
Maltese: Il-medja tal-AUClast ta' CGP52421 niżel b'60%.
English: Overall survival n/N (%)
Maltese: Sopravivenza globali n/N (%)
English: Erysipelas
Maltese: Erisipelas
English: CGP62221 exhibited a similar pattern.
Maltese: CGP62221 wera reazzjoni simili.
English: AUC0-12 was decreased by 39% and 36% in subjects with mild and moderate hepatic impairment, respectively.
Maltese: L-AUC0-12 tnaqqas b'39% u 36% f'suġġetti b'ideboliment epatiku ħafif u moderat, rispettivament.
English: A 100 mg dose of Rydapt contains approximately 14 vol. % ethanol anhydrous, which corresponds to 333 mg alcohol.
Maltese: Doża ta' 100 mg Rydapt fiha madwar 14 vol. % ethanol anhydrous, li jikkorrispondi għal 333 mg alkoħol.
English: 9/l, as recommended in Tables 1 and 2.
Maltese: 9/l, skont kif irrakkomandat f'Tabelli 1 u 2.
English: Interrupt Rydapt until ANC ≥1.0 x 10
Maltese: Interrompi Rydapt sa ANC ≥1.0 x 10
English: Disturbance in attention
Maltese: Disturb fl-attenzjoni
English: Twenty (76.9%) patients had ASM (17 [85%] with AHN) and 6 patients (23.1%) had MCL (2 [33.3%] with AHN).
Maltese: Għoxrin (76.9%) pazjent kellhom ASM (17 [85%] b'AHN) u 6 pazjenti (23.1%) kellhom MCL (2 [33.3%] b'AHN).
English: AUCtau was decreased by 28% and 20% on day 7, respectively.
Maltese: L-AUCtau tnaqqset b'28% u 20% sas-7 jum, rispettivament.
English: The supportive study was a single-arm, multicentre, open-label phase II study of 26 patients with ASM, SM-AHN and MCL (CPKC412A2213).
Maltese: II , ma' grupp wieħed, multiċentriku u open-label fost 26 pazjent b'ASM, SM-AHN u MCL (CPKC412A2213).
English: CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
Maltese: 2 = sintomi moderati; 3 = sintomi severi; 4 = sintomi li jheddu l-ħajja.
English: 56 (2 packs of 28) capsules
Maltese: 56 (2 pakketti ta' 28) kapsula
English: Hypernatraemia*
Maltese: Ipernatremija*
English: ADRs are listed according to MedDRA system organ class.
Maltese: L-ADRs qed jitniżżlu skont is-sistema ta' klassifika tal-organi MedRA.
English: The median terminal half-lives of midostaurin, CGP62221 and CGP52421 in plasma are approximately 20.9, 32.3 and 471 hours.
Maltese: Il-half-lives terminali medjani ta' midostaurin, CGP62221 u CGP52421 fil-plażma kienu ta' madwar 20.9, 32.3 u 471 siegħa.
English: Table 8 Efficacy of midostaurin in ASM, SM-AHN and MCL per IWG-MRT-ECNM consensus criteria using an algorithmic approach
Maltese: Tabella 8 L-effikaċja ta' midostaurin f'ASM, SM-AHN u MCL skont il-kriterji ta' kunsens IWG-MRT-ECNM permezz ta' approċċ algoritmiku
English: The pivotal study was a multicentre, single-arm phase II study in 116 patients with advanced SM (Study CPKC412D2201).
Maltese: II multiċentriku, ma' grupp wieħed fost 116-il pazjent b'SM avvanzata (Studju CPKC412D2201).
English: Medicinal products with a narrow therapeutic range that are substrates of CYP1A2 (e.g. tizanidine), CYP2D6 (e.g. codeine), CYP2C8 (e.g. paclitaxel), CYP2C9 (e.g. warfarin), CYP2C19 (e.g. omeprazole), CYP2E1 (e.g. chlorzoxazone), CYP3A4/5 (e.g. tacrolimus), CYP2B6 (e.g. efavirenz), P-gp (e.g. paclitaxel), BCRP (e.g. atorvastatin) or OATP1B1 (e.g. digoxin) should be used with caution when administered concomitantly with midostaurin and may need dose adjustment to maintain optimal exposure (see section 5.2).
Maltese: Il-prodotti mediċinali b'firxa terapewtika dejqa li huma sottostrati ta' CYP1A2 (eż. tizanidine), CYP2D6 (e.g. codeine), CYP2C8 (eż. paclitaxel), CYP2C9 (eż. warfarin), CYP2C19 (eż. omeprazole), CYP2E1 (eż. chlorzoxazone), CYP3A4/5 (eż. tacrolimus), CYP2B6 (eż. efavirenz), P-gp (eż. paclitaxel), BCRP (eż. atorvastatin) jew OATP1B1 (eż. digoxin) għandhom jintużaw b'attenzjoni meta jingħataw flimkien ma' midostaurin u jaf ikun hemm bżonn ta' aġġustament tad-doża sabiex tinżamm espożizzjoni ottimali (ara sezzjoni 5.2).
English: In vitro data showed midostaurin is more than 98% bound to plasma proteins, such as albumin, α1-acid glycoprotein (AGP) and lipoprotein.
Maltese: Dejta in vitro wriet li midostaurin jeħel b'aktar minn 98% mal-proteini tal-plażma, bħall-albumina, glikoproteina aċiduża-α1 (AGP) u mal-lipoproteina.
English: For CGP52421, AUC0-12h and Cmax were 2770 ng*h/ml and 299 ng/ml, respectively.
Maltese: Għal CGP52421, AUC0-12h u Cmax kienu 2770 ng*h/ml u 299 ng/ml, rispettivament.
English: - Patients with AML
Maltese: - Pazjenti b'AML
English: AUC0-12h and Cmax for CGP62221 were 8700 ng*h/ml and 931 ng/ml, respectively.
Maltese: L-AUC0-12h u s-Cmax ta' CGP62221 kienu 8700 ng*h/ml u 931 ng/ml, rispettivament.
English: Kaplan-Meier estimates at 5 years (95% CI)
Maltese: Stimi skont Kaplan-Meier f' 5 snin (95% CI)
English: The pharmacokinetics of midostaurin were less than dose proportional with the doses of 30 mg/m and 60 mg/m after single and multiple doses.
Maltese: Il-farmakokinetiċi ta' midostaurin kienu anqas mid-doża proporzjonali b'dożi ta' 30 mg/m u 60 mg/m wara doża singola u multipla.
English: Out of 116 patients, 113 had a C-finding as defined by IWG response criteria (excluding ascites as a C-finding).
Maltese: Minn 116-il pazjent, 113 kellhom sejba-C kif definita minn kriterji ta' rispons IWG (eskluż axxite bħala sejba-C).
English: Rydapt contains about 14 vol. % ethanol anhydrous, which corresponds to up to 333 mg alcohol per dose.
Maltese: Rydapt fih madwar 14 vol.% ethanol anhydrous, li jikkorrispondi għal 333 mg alkoħol għal kull doża.
English: ASM, SM-AHN and MCL
Maltese: ASM, SM-AHN u MCL
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE39
Maltese: Sustanzi antineoplastiċi, inibituri tal-proteina kinasi, Kodiċi ATC:
English: The two major human metabolites GGP52421 and CGP62221 (also tested at the limit of solubility) inhibited hERG current with moderate safety margins.
Maltese: Iż-żewġ metaboliti umani ewlenin GGP52421 u CGP62221 (ippruvati wkoll sal-limitu tas-solubbiltà) inibixxew l-kurrent hERG b'marġini moderati ta' sigurtà.
English: Population pharmacokinetic analyses were conducted using data from clinical studies in patients with AML (n=180) and ASM, SM-AHN and MCL (n=141).
Maltese: Saru analiżijiet tal-farmakokinetika fil-popolazzjoni billi ntużat dejta minn studji kliniċi f'pazjenti b'AML (n=180) u b'ASM, SM-AHN u MCL (n=141).
English: Table 6 Overview of OS, EFS, CR, DFS and CIR by gender in AML
Maltese: Ħarsa ġenerali tal-OS, EFS, CR, DFS u CIR skont is-sess f'AML
English: In proliferation assays with FLT3-ITD expressing cells, CGP62221 showed similar potency compared to the parent compound, however CGP52421 was approximately 10-fold less potent.
Maltese: Waqt provi ta' proliferazzjoni b'ċelluli li jesprimu FLT3-ITD, CGP62221 wera potenza simili mqabbla mal-kompost parentali, madanakollu CGP52421 kien madwar 10 darbiet inqas potenti.
English: There was a trend favouring midostaurin for CR rate by day 60 for the midostaurin arm (58.9% versus 53.5%; p = 0.073) that continued when considering all CRs during induction (65.0% versus 58.0%; p = 0.027).
Maltese: Kien hemm tendenza favur midostaurin fejn tidħol ir-rata tas-CR mas-60 jum fost il-grupp mogħti midostaurin (58.9% kontra 53.5%; p=0.073) li tkompliet meta tqisu s-CRs kollha matul it-tnedija (65.0% kontra 58.0%; p=0.027).
English: Tmax was delayed for all entities, midostaurin median Tmax was 3 h, and for CGP52421 and CGP62221 Tmax was delayed to 6 and 7 hours respectively.
Maltese: It-Tmax ittardja għall-entitajiet kollha, it-Tmax medjan ta' midostaurin kien 3 h, u t-Tmax ta' CGP52421 u CGP62221 ittardja b'6 u 7 sigħat rispettivament.
English: Nineteen patients (73.1%; 95% CI = [52.2, 88.4]) achieved a response during the first two cycles of treatment (13 MR; 6 PR).
Maltese: Dsatax-il pazjent (73.1%; 95% CI=[52.2, 88.4]) kisbu rispons wieħed matul l-ewwel żewġ ċikli ta' trattament (13 MR; 6 PR).
English: Two of its metabolites demonstrated pharmacological activities (CGP52421 and CGP62221).
Maltese: Tnejn mill-metaboliti tiegħu wrew attivitajiet farmakoloġiċi (CGP52421 u CGP62221).
English: Grade 3/4 nausea and/or vomiting despite optimal anti-emetic therapy
Maltese: Dardir u/jew rimitter ta' Grad 3/4 minkejja terapija anti-emetika ottimali
English: 112 (4 packs of 28) capsules
Maltese: 112-il (4 pakketti ta' 28) kapsula
English: Amylase increased*
Maltese: Żieda tal-amylase*
English: Rydapt contains the active substance midostaurin.
Maltese: Rydapt fih is-sustanza attiva midostaurin.
English: Midostaurin is metabolised by CYP3A4 mainly via oxidative pathways.
Maltese: Midostaurin hu metabolizzat b'CYP3A4 primarjament permezz tal-passaġġi ossidattivi.
English: Event Free Survival (EFS)
Maltese: Sopravivenza ħielsa minn kull episodju (EFS)
English: The pharmacokinetics of midostaurin have not been assessed in patients with baseline severe hepatic impairment (Child-Pugh Class C) (see section 4.4).
Maltese: Il-farmakokinetiċi ta' midostaurin ma ġewx evalwati f'pazjenti b'indeboliment epatiku qawwi fil-linja bażi (Child-Pugh Klassi C) (ara sezzjoni 4.4).
English: Out of the 321 patients included, 177 patients showed pre-existing mild (n=113), moderate (n=60) or severe (n=4) renal impairment (15 ml/min ≤ creatinine clearance [CrCL] <90 ml/min).
Maltese: Minn 321 pazjent inklużi, 177 pazjent urew li kellhom diġà indeboliment tal-kliewi ħafif (n=113), moderat (n=60) jew gravi (n=4) (15 ml/min ≤tneħħija tal-kreatinina [CrCL] <90 ml/min). 144 pazjent urew funzjoni normali tal-kliewi (CrCL >90 ml/min) fil-linja bażi.
English: The capsules are provided in blisters and are available in packs containing 56 capsules (2 packs of 28 capsules) or 112 capsules (4 packs of 28 capsules).
Maltese: Il-kapsuli jiġu f'folji u huma disponibbli f'pakketti li fihom 56 kapsula (2 pakketti ta' 28 kapsula) jew 112-il kapsula (4 pakketti ta' 28 kapsula).
English: Best overall response, n (%) Complete remission Partial remission Clinical improvement Duration of response* n/N (%) median (95% CI)
Maltese: Fejqan komplet Fejqan parzjali Titjib kliniku Durata tar-rispons* n/N (%) medjan (95% CI)
English: Hypercalcaemia*
Maltese: Iperkalċemija*
English: It belongs to a class of medicines called protein kinase inhibitors.
Maltese: Jappartjeni għal klassi ta' mediċini msejħa inibituri talproteina kinasi.
English: Metabolism and nutrition disorders Hyperuricaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Iperuriċemija
English: Confirmed responses were observed in both KIT D816V mutation positive patients (ORR=63%) and KIT D816V wild type or unknown patients (ORR=43.8%).
Maltese: Kienu osservati risponsi kkonfermati kemm f'pazjenti pożittivi għall-mutazzjoni KIT D816V (ORR=63%) u f'pazjenti b'KIT D816V tat-tip selvaġġ jew mhux magħrufa (ORR=43.8%).
English: Rydapt 25 mg capsules midostaurin
Maltese: Rydapt 25 mg kapsuli midostaurin
English: Due to the limited pharmacokinetic data in paediatric patients, no comparison with midostaurin pharmacokinetics in adults can be made.
Maltese: Minħabba d-dejta farmakokinetika limitata fost pazjenti pedjatriċi, ma jistax isir tqabbil mal-farmakokinetiċi ta' midostaurin fl-adulti.
English: After 100 mg bid multiple oral doses of midostaurin the Cmin,ss plasma midostaurin in AML and ASM, SMAHN, MCL patients were 919 and 1060 ng/ml, respectively.
Maltese: Wara 100 mg dożi orali multipli ta' midostaurin darbtejn kuljum is-Cmin,ss ta' midostaurin fil-plażma f'pazjenti b'AML u ASM, SM-AHN, MCL kienu ta' 919 u 1060 ng/ml, rispettivament.
English: The most frequent non-haematological laboratory abnormalities were hyperglycaemia (93.7%), total bilirubin increased (40.1%), lipase increased (39.4%), aspartate aminotransferase (AST) increased (33.8%), and alanine aminotransferase (ALT) increased (33.1%), while the most frequent haematological laboratory abnormalities were absolute lymphocyte count decreased (73.2%) and ANC decreased (58.5%).
Maltese: L-aktar anormalitajiet mhux ematoloġiċi frekwenti li dehru fil-laboratorju kienu ipergliċemija (93.7%), żieda fl-ammont sħiħ ta' bilirubina (40.1%), żieda fil-lipase (39.4%), żieda fl-aspartate aminotransferase (AST) (33.8%), u żieda fl-alanine aminotransferase (ALT) (33.1%), filwaqt li l-aktar anormalitajiet ematoloġiċi frekwenti li dehru fillaboratorju kienu t-tnaqqis tal-ammont assolut ta' limfoċiti (73.2%) u t-tnaqqis tal-ANC (58.5%).
English: Anorectal discomfort
Maltese: Skumdità anorettali
English: Embryofoetal toxicity and breast-feeding
Maltese: Tossiċità embrijofetali u treddigħ
English: 9/l attributed to Rydapt in patients with baseline platelet count of 25-75 x 10
Maltese: Rydapt f'pazjenti b'għadd ta' plejtlits fil-linja bażi ta' 25-75 x 10
English: At steady state of midostaurin (50 mg twice daily for 21 days), with the strong CYP3A4 inhibitor itraconazole at steady state in a subset of patients (N=7), midostaurin steady-state exposure (Cmin) was increased by 2.09-fold.
Maltese: Midostaurin fi stat fiss (50 mg darbtejn kuljum għal 21 jum), mal-inibitur qawwi CYP3A4 itraconazole fi stat fiss lil sottogrupp ta' pazjenti (N=7), midostaurin fi stat fiss (Cmin) żdied bi 2.09 drabi.
English: The most frequent ADRs were nausea (82%), vomiting (68%), diarrhoea (51%), peripheral oedema (35%) and fatigue (31%).
Maltese: L-aktar ADRs frekwenti kienu dardir (82%), rimettar (68%), dijarrea (51%), edema periferali (35%) u għeja (31%).
English: What Rydapt looks like and contents of the pack Rydapt 25 mg soft capsules are pale orange, oblong capsules with red imprint “PKC NVR”.
Maltese: Rydapt 25 mg kapsuli rotob li huma ta' lewn oranġjo ċars, kapsuli tawwalija bil-kliem “PKC NVR” stampat bl-aħmar.
English: 9/l attributed to Rydapt in patients with baseline ANC value of 0.5-1.5 x 10
Maltese: 9/l attribwit għal Rydapt f'pazjenti b'valur ANC fillinja bażi ta' 0.5-1.5 x 10
English: Males 95% CI
Maltese: Nisa 95% CI
English: The usual daily dose is 100 mg (4 capsules) twice daily.
Maltese: Id-doża li normalment tingħata hi ta' 100 mg (4 kapsuli) darbtejn kuljum.
English: Table 7 Efficacy of midostaurin in ASM, SM-AHN and MCL: primary efficacy population
Maltese: Tabella 7 L-effikaċja ta' midostaurin f'ASM, SM-AHN u MCL: popolazzjoni li tivverifika l effikaċja primarja
English: Midostaurin (n=360) Median: 74.7 months Placebo (n=357) Median: 25.6 months HR: 0.774 (95% CI, 0.629-0.953) P = 0.0078
Maltese: 6 xhur HR: 0.774 (95% CI, 0.629-0.953) P=0.0078
English: ADRs that led to treatment discontinuation occurred in 9.2% of patients.
Maltese: ADRs li wasslu għal twaqqif għal kollox tat-trattament seħħew fi 9.2% tal-pazjenti.
English: The usual daily dose is 50 mg (2 capsules) twice daily.
Maltese: Id-doża li normalment tingħata hi ta' 50 mg (2 kapsuli) darbtejn kuljum.
English: The EFS showed a statistically significant improvement for midostaurin plus standard chemotherapy over placebo plus standard chemotherapy (HR: 0.78 [95% CI, 0.66 to 0.93] p = 0.0024), and a median EFS of 8.2 months and 3.0 months, respectively; see Table 5.
Maltese: L-EFS wera titjib sinifikanti statistikament għal midostaurin flimkien ma' kimoterapija standard meta mqabbel ma' plaċebo flimkien ma' kimoterapija standard (HR: 0.78 [95% CI, 0.66 to 0.93] p = 0.0024), u l-EFS medjan ta' 8.2 xhur u 3.0 xhur, rispettivament; ara Tabella 5.
English: 56 (2 packs of 28) capsules 112 (4 packs of 28) capsules
Maltese: 56 (2 pakketti ta' 28) kapsula 112-il kapsula (4 pakketti ta' 28)
English: Acute promyelocytic leukaemia
Maltese: Lewkimja promieloċitika akuta
English: In the ASM, SM-AHN and MCL studies cardiac dysfunction such as congestive heart failure (CHF) (including some fatalities) and transient decreases in left ventricular ejection fraction (LVEF) occurred.
Maltese: ASM, SM-AHN u MCL, kien hemm każijiet ta' disfunzjoni kardijaka fosthom insuffiċjenza konġestiva tal-qalb (CHF) (inkluż xi fatalitajiet) u tnaqqis tranżitorju tal-frazzjoni tat-tfigħ 'il barra talventrikulu tax-xellug (LVEF).
English: • as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Maltese: • bħala monoterapija għat-trattament ta' pazjenti adulti b'mastoċitożi sistemika aggressiva (ASM), mastoċitożi sistemika b'neoplażma ematoloġika assoċjata (SM-AHN), jew lewkimja tal-mast cell (MCL).
English: The CGP52421, Cmin,ss in the AML and the ASM, SM-AHN, MCL population were 8630 ng/ml and 2860 ng/ml, respectively.
Maltese: Is-Cmin,ss ta' CGP52421, fil-pazjenti b'AML u fil-popolazzjoni b'ASM, SM-AHN, MCL kienu ta' 8630 ng/ml u 2860 ng/ml, rispettivament.
English: The mean apparent plasma clearance (CL/F) was 2.4-3.1 l/h in healthy subjects.
Maltese: It-tneħħija apparenti medja tal-plażma (CL/F) kienet ta' 2.4-3.1 l/h f'suġġetti b'saħħithom.
English: Responses to midostaurin are shown in Table 7.
Maltese: Ir-rispons għal midostaurin qed jidher f'Tabella 7.
English: The CGP62221 Cmin, ss in the AML and the ASM, SM-AHN, MCL population were 1610 ng/ml and 2020 ng/ml, respectively.
Maltese: Is-Cmin, ss ta' CGP62221 fil-pazjenti b'AML u fil-popolazzjoni b'ASM, SM-AHN, MCL kien ta' 1610 ng/ml u 2020 ng/ml, rispettivament.
English: ASM SM-AHN MCL Subtype unknown
Maltese: SM-AHN MCL Sottotip mhux magħruf
English: Lipase increased*
Maltese: Żieda tal-lipase*
English: Based on an interim analysis, the EFS rate at 2 years (primary endpoint) was 27.1% (95% CI: 16.6, 44.1) and the median OS was 15.5 months in patients older than 60 years of age (46 out of 145 patients).
Maltese: Abbażi ta' analiżi interim, ir-rata EFS ta' sentejn (endpoint primarju) kienet ta' 27.1% (95% CI: 16.6, 44.1) u l-OS medjana kienet ta' 15.5 xhur f'pazjenti li għandhom iktar minn 60 sena (46 minn 145 pazjent).
English: For all other adverse events, only grades 3 and 4 were collected.
Maltese: Għall-episodji avversi l-oħra kollha, gradi 3 u 4 biss inġabru.
English: The overall rate of SCT was 59.4% (214/360) of patients in the midostaurin plus standard chemotherapy arm versus 55.2% (197/357) in the placebo plus standard chemotherapy arm. All patients were followed for survival.
Maltese: Ir-rata globali ta' SCT kienet ta' 59.4% (214/360) tal-pazjenti fil-grupp mogħti midostaurin flimkien ma' kimoterapija standard kontra 55.2% (197/357) fil-grupp mogħti l-plaċebo flimkien ma' kimoterapija standard.
English: Rydapt contains macrogolglycerol hydroxystearate (castor oil) Rydapt contains macrogolglycerol hydroxystearate, which may cause stomach discomfort and diarrhoea.
Maltese: Rydapt fih macrogolglycerol hydroxystearate (żejt kastru) Rydapt fih macrogolglycerol hydroxystearate (żejt kastru), li jista' jikkawża skumdità fl-istonku u dijarrea.
English: Midostaurin is not an inhibitor of CYP3A4 in vivo.
Maltese: Midostaurin mhuwiex inibitur ta' CYP3A4 in vivo.
English: Of these, 73 patients had ASM (57 with an AHN) and 16 patients had MCL (6 with an AHN).
Maltese: Minnhom, 73 pazjent kellhom ASM (57 b'AHN) u 16-il pazjent kellhom MCL (6 b'AHN).
English: Syncope
Maltese: Sinkopè
English: Patients with newly diagnosed FLT3-mutated AML as determined by a clinical study assay were randomised (1:1) to receive midostaurin 50 mg twice daily (n=360) or placebo (n=357) sequentially in combination with standard daunorubicin (60 mg/m daily on days 1-3) / cytarabine (200 mg/m daily on days 1-7) induction and high-dose cytarabine (3 g/m every 12 hours on days 1, 3, 5) consolidation, followed by continuous midostaurin or placebo treatment according to initial assignment for up to 12 additional cycles (28 days/cycle).
Maltese: Pazjenti li għadha kif saritilhom dijanjosi ta' AML b'mutazzjoni tal-FLT3 kif determinat waqt prova ta' studju kliniku ngħażlu b'mod randomizzat (1:1) sabiex jirċievu midostaurin 50 mg darbtejn kuljum (n=360) jew plaċebo (N=357) wara xulxin flimkien ma' induzzjoni standard ta' daunorubicin (60 mg/m kuljum fil-ġranet 1-3)/cytarabine (200 mg/m kuljum fil-ġranet 1-7) u konsolidazzjoni b'doża għolja ta'
English: The most frequent laboratory abnormalities were haemoglobin decreased (97.3%), ANC decreased (86.7%), ALT increased (84.2%), AST increased (73.9%) and hypokalaemia (61.7%).
Maltese: L-iktar anormalitajiet frekwenti fillaboratorju kienu tnaqqis fl-emoglobina (97.3%), tnaqqis fl-ANC (86.7%), żieda fl-ALT (84.2%), żieda fl-AST (73.9%) u ipokalemija (61.7%).
English: Cytochrome P450 inhibition
Maltese: Induzzjoni taċ-ċitokromu P450
English: Investigations Hyperglycaemia (non-fasting)*
Maltese: Investigazzjonijiet Ipergliċemija (mhux wara sawm)*
English: In vitro experiments demonstrated that midostaurin, CGP52421 and CPG62221 can potentially inhibit P-gp, BCRP, OATP1B1 and BSEP.
Maltese: Interazzjonijiet bejn it-trasportatur ta' mediċina u oħra Esperimenti in vitro wrew li midostaurin, CGP52421 u CPG62221 jistgħu potenzjalment jinibixxu P-gp, BCRP, OATP1B1 u BSEP.
English: The protocol includes a comprehensive collection of baseline data (including biomarkers), post-study treatments, and evaluation of minimal residual disease (MRD).
Maltese: Il-protokoll jinkludi ġabra komprensiva ta' dejta fil-linja bażi (li tinkludi bijomarkaturi), trattamenti wara listudju, u evalwazzjoni tar-residwu minimu tal-marda (MRD).
English: Maintenance only Grade 4 neutropenia (ANC <0.5 x 10
Maltese: Newtropenja fi grad 4 (ANC <0.5 x 10
English: Respiratory, thoracic and mediastinal disorders Dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Dispnea
English: Other medicines and Rydapt
Maltese: Mediċini oħra u Rydapt
English: ADRs occurring more often in the midostaurin arm versus placebo during maintenance included: nausea (46.4% versus 17.9%), hyperglycaemia (20.2% versus 12.5%), vomiting (19% versus 5.4%) and QT prolongation (11.9% versus 5.4%).
Maltese: L-ADRs li jseħħu aktar ta' spiss fil-grupp ta' midostaurin meta mqabbel ma' plaċebo matul il-manutenzjoni jinkludu: dardir (46.4% meta mqabbel ma' 17.9%), ipergliċemija (20.2% meta mqabbel ma'12.5%), rimettar (19% meta mqabbel ma' 5.4%) u titwil talQT (11.9% meta mqabbel ma' 5.4%).
English: Table 3 Adverse drug reactions observed in the AML clinical study
Maltese: Tabella 3 Reazzjonijiet avversi tal-mediċina osservata waqt l-istudju kliniku dwar AML
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first, using the following convention (CIOMS III): 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); not known (cannot be estimated from the available data).
Maltese: F'kull sistema tal-klassifika tal-organu, l-ADRs qed jidhru skont il-frekwenza, bl-aktar reazzjonijiet frekwenti jidhru l-ewwel, filwaqt li qed tintuża l-konvenzjoni li ġejja (CIOMS III): 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); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Spleen volume decreased by ≥10% in 68.9% of patients with at least 1 post-baseline assessment (26.7% of patients had a reduction of ≥35%, which correlates with a 50% decrease by palpation).
Maltese: Il-volum talmilsa naqas b'≥10% fi 68.9% tal-pazjenti b'mill-inqas evalwazzjoni waħda wara dik imkejla fil-linja bażi (26.7% tal-pazjenti kellhom tnaqqis ta' ≥35%, li jorbot ma' 50% tnaqqis permezz talpalpazzjoni).
English: The most frequent Grade 3/4 haematological abnormalities reported in patients during the maintenance phase with Rydapt were ANC decrease (20.8% versus 18.8%) and leukopenia (7.5% versus 5.9%).
Maltese: L-iktar anormalitajiet ematoloġiċi frekwenti fi Grad 3/4 rrappurtati f'pazjenti matul il-fażi ta' manutenzjoni b'Rydapt kienu t-tnaqqis fl-ANC (20.8% kontra 18.8%) u lewkopenija (7.5% kontra 5.9%).