FrancophonIA/ELRC3.0 huggingface dataset:
English: The study protocol shall be entered in the EU electronic register of post-authorisation studies (EU PAS Register) before the start of data collection.
Maltese: Il-protokoll tal-istudju għandu jiddaħħal fir-reġistru elettroniku tal-UE ta' studji ta' wara lawtorizzazzjoni (Reġistru PAS tal-UE) qabel il-bidu tal-ġbir tad-dejta.
English: Ribociclib 334 294 277 257 240 227 207 196 188 176 164 132 97 46 Placebo 334 279 265 239 219 196 179 156 138 124 110 93
Maltese: Ribociclib 334 294 277 257 240 227 207 196 188 176 164 132 97 46 Plaċebo 334 279 265 239 219 196 179 156 138 124 110 93
English: Grade 4* (ANC <500/mm
Maltese: Grad 4* (ANC <500/mm
English: • A treatment cycle lasts 28 days.
Maltese: • Ċiklu ta' trattament idum 28 jum.
English: Clinical benefit rate (CBR)
Maltese: Rata ta' benefiċċju kliniku (CBR)
English: No of events
Maltese: Numru ta' avvenimenti
English: 0.593 (0.480 to 0.732)
Maltese: 0.593 (0.480 sa 0.732)
English: • Antibiotics such as clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin,
Maltese: • Antibijotiċi bħal clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin,
English: Overall response rate (ORR)
Maltese: Rata ta' rispons globali (ORR)
English: Log-rank p-value = 0.00973
Maltese: Il-valur-p log-rank = 0.00973
English: Baseline grade <2:
Maltese: Linja bażi grad <2:
English: Table 11 MONALEESA-7 - Efficacy results (OS)
Maltese: Tabella 11 MONALEESA-7 - Riżultati tal-effikaċja (OS)
English: The major circulating metabolites included metabolite M13 (CCI284, N-hydroxylation), M4 (LEQ803, N-demethylation), and M1 (secondary glucuronide).
Maltese: Il-metaboliti prinċipali fiċ-ċirkolazzjoni inkludew il-metabolit M13 (CCI284, N-hydroxylation), M4 (LEQ803, N-demethylation), u M1 (glukuronid sekondarju).
English: CYP3A4 substrates
Maltese: Sottosrati ta' CYP3A4
English: Ribociclib+Fulvestrant: 210, Placebo+Fulvestrant: 151 Hazard Ratio = 0.593
Maltese: Ribociclib+Fulvestrant: 210, Plaċebo+Fulvestrant: 151 Proporzjon ta' Periklu = 0.593
English: Grade 4**
Maltese: Grad 4**
English: In vitro interaction data
Maltese: Data mill-interazzjoni in vitro
English: Grade 3* (ANC
Maltese: Grad 3* (ANC
English: ECGs with QTcF >480 msec
Maltese: ECGs bi QTcF ta' >480 msec
English: Grade 3**
Maltese: Grad 3**
English: Coating material: iron oxide black (E172); iron oxide red (E172); soya lecithin (E322); polyvinyl alcohol (partially hydrolysed); talc; titanium dioxide (E171); xanthan gum.
Maltese: Materjali tal-kisja: iron oxide iswed (E172); iron oxide aħmar (E172); soya lecithin (E322); polyvinyl alcohol (partially hydrolysed); talc; titanium dioxide (E171); xanthan gum.
English: Ribociclib is primarily metabolised by CYP3A4.
Maltese: Ribociclib huwa primarjament metabolizzat permezz ta' CYP3A4.
English: Tablet core: microcrystalline cellulose; crospovidone type A; low-substituted hydroxypropylcellulose; magnesium stearate; colloidal anhydrous silica.
Maltese: Qalba tal-pillola: microcrystalline cellulose; crospovidone tip A; hydroxypropylcellulose sostitwit b'mod baxx; magnesium stearate; colloidal anhydrous silica.
English: ANC = absolute neutrophil count; LLN = lower limit of normal
Maltese: ANC = ammont assolut ta' newtrofili; LLN = l-anqas limitu tan-normal
English: • Analgesics such as alfentanil and fentanyl.
Maltese: • Analġeżiċi bħal alfentanil u fentanyl.
English: ECGs with QTcF >500 msec
Maltese: ECGs bi QTcF ta' >500 msec
English: Log rank p-value = 4.10*10^(-7)
Maltese: Il-valur-p (log-rank) = 4.10*10^(-7)
English: Hypocalcaemia, hypokalaemia, hypophosphataemia
Maltese: Ipokalċimija, ipokalimija, ipofosfatimija
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) or PA/alu/PVC (polyamide/aluminium/polyvinylchloride) blisters containing 14 or 21 film-coated tablets.
Maltese: Folji tal-PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) jew PA/alu/PVC (polyamide/aluminium/polyvinylchloride) li fihom 14 jew 21 pillola miksija b'rita.
English: • Antimalarials such as chloroquine.
Maltese: • Mediċini kontra l-malarja bħal chloroquine.
English: nelfinavir, telaprevir and efavirenz.
Maltese: nelfinavir, telaprevir u efavirenz.
English: • Antiarrhythmics such as amiodarone or quinidine.
Maltese: • Antiarritmiċi bħal amiodarone jew quinidine.
English: • Antipsychotics such as pimozide or quetiapine.
Maltese: • Antipsikotiċi bħal pimozide jew quetiapine.
English: Reproductive toxicity/Fertility
Maltese: Effett tossiku fuq is-sistema riproduttiva/Fertilità
English: 400 mg/day
Maltese: 400 mg/jum
English: Kisqali plus fulvestrant N=484
Maltese: Kisqali flimkien ma' fulvestrant N=484
English: Each film-coated tablet contains 0.344 mg soya lecithin.
Maltese: Kull pillola miksija b'rita fiha 0.344 mg leċitina tas-soja.
English: pravastatin or rosuvastatin.
Maltese: pitavastatin, pravastatin jew rosuvastatin.
English: Event-free probability (%)
Maltese: Probabbiltà ħielsa minn episodju (%)
English: ** Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events)
Maltese: * Gradazzjoni skont CTCAE Verżjoni 4.03 (CTCAE = Kriterji għal Terminoloġija Komuni għal Avvenimenti Avversi
English: Grade 1* (> ULN3 x ULN)
Maltese: Grad 1* (> ULN3 x ULN)
English: Log rank p-value = 9.83*10^(-8)
Maltese: Il-valur-p (log-rank) = 9.83*10^(-8)
English: - PFS based on investigator radiological assessment
Maltese: - PFS ibbażata fuq valutazzjoni radjoloġika tal-investigatur
English: In vitro, ribociclib is a reversible inhibitor of CYP1A2, CYP2E1 and CYP3A4/5 and a time-dependent inhibitor of CYP3A4/5, at clinically relevant concentrations.
Maltese: In vitro, ribociclib hu inibitur riversibbli ta' CYP1A2, CYP2E1 u CYP3A4/5 u inibitur ta' CYP3A4/5 dipendenti miż-żmien, b'konċentrazzjonijiet relevanti klinikament.
English: The patients included were Caucasian (82.2%), Asian (7.6%), and Black (2.5%).
Maltese: Il-pazjenti inklużi kienu Kawkasi (82.2%), Asjatici (7.6%), u Suwed (2.5%).
English: c p-values are obtained from one-sided Cochran-Mantel-Haenszel chi-square test
Maltese: c valuri p jinkisbu mit-test chi-square ta' Cochran-Mantel-Haenszel ta' naħa waħda
English: Overall response rate a
Maltese: Rata ta' rispons globali a
English: Iron oxide black (E172) Iron oxide red (E172) Soya lecithin (E322) Polyvinyl alcohol (partially hydrolysed) Talc
Maltese: Iron oxide iswed (E172) Iron oxide aħmar (E172) Soya lecithin (E322)
English: A more mature update of efficacy data (02 January 2017 cut-off) is provided in Tables 7 and 8.
Maltese: Aġġornament aktar matur ta' data tal-effikaċja (data meta waqfet tinġabar id-data 02 ta' Jannar, 2017) huwa pprovdut fit-Tabelli 7 u 8.
English: The dose should be interrupted.
Maltese: Id-doża għandha tiġi interrotta.
English: Clinical benefit rate b a
Maltese: Rata ta' benefiċċju kliniku b a
English: Overall survival, NSAI subgroup
Maltese: Sopravivenza sħiħa, sottogrupp NSAI
English: p-value a
Maltese: valur-p a
English: Hazard Ratio = 0.699 95% CI [0.501, 0.976]
Maltese: Proporzjon ta' periklu = 0.699 95% CI [0.501, 0.976]
English: Grade 1 or 2* (ANC
Maltese: Grad 1 jew 2* (ANC
English: Placebo N=337
Maltese: Plaċebo N=337
English: Hazard ratio (95% CI) p-value a
Maltese: Proporzjon ta' periklu (95% CI) valur-p a
English: There were no reported cases of torsade de pointes.
Maltese: Ma kien hemm l-ebda każ irrappurtat ta' torsade de pointes.
English: What Kisqali contains - The active substance is ribociclib.
Maltese: X'fih Kisqali - Is-sustanza attiva hi ribociclib.
English: Effect of transporters on ribociclib
Maltese: Effetti tat-trasportaturi fuq ribociclib
English: • The recommended starting dose of Kisqali is 600 mg (3 tablets of 200 mg) once daily.
Maltese: • Id-doża tal-bidu rakkomandata ta' Kisqali hija 600 mg (3 pilloli ta' 200 mg) darba kuljum.
English: There is also potential to induce incidences of premature ventricular contractions (PVCs) at elevated exposures (approximately 5-fold the anticipated clinical Cmax).
Maltese: Hemm ukoll il-potenzjal li jinduċi inċidenzi ta' kontrazzjonijiet prematuri tal-ventriklu (PVCs - premature ventricular contractions) b'esponimenti elevati (madwar 5 darbiet Cmax klinika antiċipata).
English: • with electrolyte abnormalities.
Maltese: • b'anormalitajiet fl-elettroliti.
English: Grade 3 or 4 increases in ALT (9.7% versus 1.5%) and AST (6.7% versus 2.1%) were reported in the Kisqali and placebo arms, respectively.
Maltese: Żidiet ta' Grad 3 jew 4 fl-ALT (9.7% kontra 1.5%) u fl-AST (6.7% kontra 2.1%) kienu rrappurtati fil-gruppi ta' Kisqali u plaċebo, rispettivament.
English: Median PFS [months] (95% CI)
Maltese: PFS medjana [xhur] (95% CI)
English: Placebo N=247
Maltese: Plaċebo N=247
English: In vitro evaluations indicated that ribociclib has a potential to inhibit the activities of drug transporters P-gp, BCRP, OATP1B1/1B3, OCT1, OCT2, MATE1 and BSEP.
Maltese: Evalwazzjonijiet in vitro indikaw li ribociclib għandu potenzjal li jinibixxi l-attivitajiet tat-trasportaturi tal-mediċini P-gp, BCRP, OATP1B1/1B3, OCT1, OCT2, MATE1 u BSEP.
English: No of events Ribociclib: 92, Placebo: 132
Maltese: Nru ta' avvenimenti Ribociclib: 92, Plaċebo: 132
English: ) with clinically meaningful treatment effect.
Maltese: ) b'effett ta' trattament klinikament sinifikanti.
English: congestive heart failure, unstable angina and bradyarrhythmias;
Maltese: insuffiċjenza konġestiva tal-qalb, anġina instabbli u bradiarritmija;
English: • Some medicines used to treat HIV/AIDS such as ritonavir, saquinavir, indinavir, lopinavir,
Maltese: • Xi mediċini użati biex jittrattaw HIV/AIDS bħal ritonavir, saquinavir, indinavir, lopinavir,
English: No of events- Ribociclib: 140, Placebo: 205
Maltese: Nru ta' episodji- Ribociclib: 140, Plaċebo: 205
English: In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
Maltese: Evalwazzjonijiet in vitro indikaw li ribociclib m'għandux il-potenzjal li jinibixxi l-attivitajiet ta' CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u CYP2D6 f'konċentrazzjonijiet relevanti klinikament.
English: voriconazole or posaconazole.
Maltese: itraconazole, voriconazole jew posaconazole.
English: The concomitant use of strong CYP3A4 inducers should be avoided, including, but not limited to, phenytoin, rifampicin, carbamazepine and St John's Wort (Hypericum perforatum).
Maltese: L-użu fl-istess waqt ta' indutturi qawwija ta' CYP3A4 għandu jiġi evitat inklużi, iżda mhux limitat għal, phenytoin, rifampicin, carbamazepine u St John's Wort (Hypericum perforatum).
English: Effect of ribociclib on transporters
Maltese: Effetti ta' ribociclib fuq it-trasportaturi
English: LEQ803 Cmax increased 1.7-fold and AUCinf decreased by 27%, respectively.
Maltese: Cmax ta' LEQ803 żdiedet b'1.7 darbiet u AUCinf naqset b'27%, rispettivament.
English: QT interval prolongation
Maltese: Titwil tal-interval QT
English: The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb).
Maltese: Il-kumpless cyclin D-CDK4/6 jirregola l-progressjoni taċ-ċiklu taċ-ċellula permezz ta' fosforilazzjoni tal-proteina tar-retinoblastoma (pRB - retinoblastoma protein).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE42
Maltese: Aġenti antineoplastiċi, inibituri tal-proteina tal-kinase, Kodiċi ATC:
English: If patients develop ALT and/or AST >3 x ULN along with total bilirubin >2 x ULN irrespective of baseline grade, discontinue Kisqali.
Maltese: ALT u/jew AST >3 x ULN flimkien ma' bilirubina totali >2 x ULN irrispettivament mill-grad tal-linja bażi, waqqaf Kisqali.
English: Kisqali contains soya lecithin.
Maltese: Kisqali fih il-leċitina tas-soja.
English: Study CLEE011F2301 (MONALEESA-3)
Maltese: Studju CLEE011F2301 (MONALEESA-3)
English: Censoring times Ribociclib+Fulvestrant (N=484) Placebo+Fulvestrant (N=242)
Maltese: Żminijiet ta' ċensura Ribociclib+Fulvestrant (N=484) Plaċebo+Fulvestrant (N=242)
English: Ribociclib is a selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6, resulting in 50% inhibition (IC50) values of 0.01 (4.3 ng/ml) and 0.039 μM (16.9 ng/ml) in biochemical assays, respectively.
Maltese: Ribociclib huwa inibitur selettiv ta' kinase dipendenti minn cyclin (CDK - cyclin-dependent kinase) 4 u 6, u jwassal għall-valuri ta' inibizzjoni ta' 50% (IC50 - 50% inhibition) ta' 0.01 (4.3 ng/ml) u 0.039 μM (16.9 ng/ml) f'analiżi bijokimiċi, rispettivament.
English: Grade 4* (>20 x ULN)
Maltese: Grad 4* (>20 x ULN)
English: Concomitant administration of ribociclib at the 600 mg dose with the following CYP3A4 substrates should be avoided: alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam.
Maltese: L-għoti ta' ribociclib b'doża ta' 600 mg flimkien mas-sottostrati ta' CYP3A4 li ġejjin għandu jiġi evitat: alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam.
English: Metabolite LEQ803 was a significant metabolite in excreta and represented approximately 13.9% and 3.74% of the administered dose in faeces and urine, respectively.
Maltese: Il-metabolit LEQ803 kien metabolit sinifikanti fl-ekskreta u rrappreżenta madwar 13.9% u 3.74% tad-doża mogħtija fl-ippurgar u fl-awrina, rispettivament.
English: Soya lecithin
Maltese: Leċitina tas-soja
English: No of events Ribociclib: 83, Placebo: 109
Maltese: Numru ta' avvenimenti Ribociclib: 83, Plaċebo: 109
English: Number of events - n [%] Median OS [months] (95% CI) NE (NE, NE)
Maltese: Numru ta' episodji - n [%] OS medjan [xhur] (95% CI)
English: Progression free survival a
Maltese: Sopravivenza mingħajr progressjoni a
English: A pharmacokinetic-pharmacodynamic analysis included a total of 997 patients treated with ribociclib at doses ranging from 50 to 1200 mg.
Maltese: Analiżi talfarmakokinetika u l-farmakodinamika inkludiet total ta 997 pazjent ttrattati b'ribociclib b'dożi li jvarjaw minn 50 sa 1,200 mg.
English: Time (months) Ribociclib Placebo
Maltese: Żmien (xhur) Ribociclib Plaċebo
English: After initiating treatment, liver function should be monitored (see sections 4.2 and 4.8).
Maltese: Wara li jinbeda t-trattament, il-funzjoni tal-fwied għandha tiġi mmonitorjata (ara sezzjonijiet 4.2 u 4.8).
English: Multipack: 63 (3 packs of 21) film-coated tablets Multipack: 126 (3 packs of 42) film-coated tablets Multipack: 189 (3 packs of 63) film-coated tablets
Maltese: Pakkett multiplu: 63 (3 pakketti ta' 21) pillola miksija b'rita Pakkett multiplu: 126 (3 pakketti ta' 42) pillola miksija b'rita Pakkett multiplu: 189 (3 pakketti ta' 63) pillola miksija b'rita
English: Updated analysis (30 November 2018 cut-off)
Maltese: Analiżi aġġornata (data meta waqfet tinġabar id-data 30 ta' Novembru 2018)
English: Kisqali + letrozole (%, 95% CI)
Maltese: Kisqali + letrozole (%, CI ta' 95%)
English: Distribution of PFS is summarised in Table 12 and in the Kaplan-Meier curve for PFS in Figure 6.
Maltese: Id-distribuzzjoni tal-PFS hija miġbura fil-qosor fit-Tabella 12 u ful-kurva Kaplan-Meier għall-PFS filFigura 6.
English: Study CLEE011A2301 (MONALEESA-2)
Maltese: Studju CLEE011A2301 (MONALEESA-2)
English: No of events Ribociclib: 61, Placebo: 80
Maltese: Numru ta' episodji Ribociclib: 61, Plaċebo: 80
English: Erythema, dry skin, vitiligo
Maltese: Eritema, ġilda xotta, vitiligo
English: The concomitant use of strong CYP3A4 inhibitors including, but not limited to, the following must be avoided: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir, ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, verapamil and voriconazole (see section 4.4).
Maltese: L-użu fl-istess waqt ta' inibituri qawwija ta' CYP3A4 inklużi, iżda mhux limitat għal dawn li ġejjin, għandu jiġi evitat: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir, ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, verapamil u voriconazole (ara sezzjoni 4.4).
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Grade 3 neutropenia with a single fever >38.3°C (or above 38°C for more than one hour and/or concurrent infection)
Maltese: [Common Terminology Criteria for Adverse Events]) ** Newtropenija ta' grad 3 b'episodju wieħed ta' deni ta' >38.3°C (jew 'il fuq minn 38°C għal aktar minn siegħa u/jew infezzjoni fl-istess waqt)
English: Hazard Ratio = 0.712 95% CI [0.535, 0.948]
Maltese: 712 95% CI [0.535, 0.948]
English: Kisqali 200 mg film-coated tablets ribociclib
Maltese: Kisqali 200 mg pilloli miksija b'rita ribociclib
English: In addition, the corresponding frequency category for each adverse drug reaction is based on 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); and not known (cannot be estimated from the available data).
Maltese: Barra dan, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċini hija bbażata fuq il-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); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • Some medicines used as antipsychotics such as haloperidol.
Maltese: • Xi mediċini użati bħala antipsikotiċi bħal haloperidol.
English: Study CLEE011E2301 (MONALEESA-7)
Maltese: Studju CLEE011E2301 (MONALEESA-7)
English: Phase II conjugates of ribociclib phase I metabolites involved N-acetylation, sulfation, cysteine conjugation, glycosylation and glucuronidation.
Maltese: II ta' metaboliti ta' fażi I ta' ribociclib involvew N-acetylation, sulfation, konjugazzjoni ma' cysteine, żieda ta' gruppi glycosyl u glukuronidazzjoni.
English: Show the Kisqali packet.
Maltese: Uri l-pakkett ta' Kisqali.
English: In the phase III clinical studies 8.4% of patients in the Kisqali plus aromatase inhibitor or fulvestrant arms and 3.2% in the placebo plus aromatase inhibitor or fulvestrant arms had at least one event of QT interval prolongation (including ECG QT prolonged and syncope).
Maltese: III 8.4% tal-pazjenti fil-gruppi ta' Kisqali flimkien mal-inibitur ta' aromatase jew fulvestrant u 3.2% fil-gruppi tal-plaċebo flimkien mal-inibitur ta' aromatase jew fulvestrant kellhom mill-inqas avveniment wieħed ta' titwil tal-intervall QT (inkluż ECG QT imtawwal u sinkope).
English: Placebo + letrozole (%, 95% CI)
Maltese: Plaċebo + letrozole (%,CI ta' 95%)
English: Anti-arrhythmic medicinal products and other medicinal products that may prolong the QT interval Co-administration of Kisqali with medicinal products with a known potential to prolong the QT interval such as anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol), and other medicinal products that are known to prolong the QT interval (including, but not limited to, chloroquine, halofantrine, clarithromycin, ciprofloxacin, levofloxacin, azithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide and intravenous ondansetron) should be avoided (see section 4.4).
Maltese: Prodotti mediċinali anti-arritmiċi u prodotti mediċinali oħra li jistgħu jtawlu l-intervall QT L-għoti ta' Kisqali flimkien ma' prodotti mediċinali b'potenzjal magħruf biex ittawlu l-intervall QT bħal prodotti mediċinali anti-arritmiċi (inklużi, iżda mhux limitat għal, amiodarone, disopyramide, procainamide, quinidine u sotalol), u prodotti mediċinali oħra li huma magħrufa li jtawlu l-intervall QT (inklużi, iżda mhux limitat għal, chloroquine, halofantrine, clarithromycin, ciprofloxacin, levofloxacin, azithromycin, haloperidol, methadone, moxifloxacin, bepridil, pimozide u ondansetron fil-vini) għandu jiġi evitat (ara sezzjoni 4.4).
English: Review of ECG data showed 14 patients (1.3%) had >500 msec post-baseline QTcF value, and 59 patients (5.6%) had a >60 msec increase from baseline in QTcF intervals.
Maltese: Analiżi ta' data tal-ECG uriet li 14-il pazjent wieħed (1.3%) kellhom valur ta' QTcF wara llinja bażi ta' >500 msec, u 59 pazjent (5.6%) kellhom żieda ta' >60 msec mil-linja bażi fl-intervalli QTcF.
English: Effect of age, weight, gender and race
Maltese: Effett tal-età, piż, sess u razza
English: Anticipated interactions
Maltese: Interazzjonijiet mistennija
English: Clinical benefit rate b
Maltese: Rata ta' benefiċċju kliniku b
English: The mean exposure for ribociclib was increased less than 2-fold in patients with moderate (geometric mean ratio [GMR]: 1.44 for Cmax; 1.28 for AUCinf) and severe (GMR: 1.32 for Cmax; 1.29 for AUCinf) hepatic impairment (see section 4.2).
Maltese: L-esponiment medju għal ribociclib żdied b'inqas minn darbtejn f'pazjenti b'indeboliment moderat (proporzjon ġeometriku medju [GMR - geometric mean ratio]: 1.44 għal Cmax; 1.28 għal AUCinf) u sever (GMR: 1.32 għal Cmax; 1.29 għal AUCinf) tal-fwied (ara sezzjoni 4.2).
English: Time (months) Ribociclib+ Fulvestrant Placebo+Fulvestrant
Maltese: Żmien (xhur) Ribociclib+ Fulvestrant
English: Table 13 MONALEESA-3 - Efficacy results (ORR, CBR) based on investigator assessment
Maltese: Tabella 13 MONALEESA-3 - Riżultati tal-effikaċja (ORR, CBR) ibbażati fuq valutazzjoni tal-investigatur
English: • Tiredness, pale skin (potential sign of a low level of red blood cells, anaemia)
Maltese: • Għeja, ġilda pallida (sinjal potenzjali ta' livell baxx ta' ċelluli ħomor tad-demm, anemija)
English: levofloxacin and azithromycin.
Maltese: levofloxacin u azithromycin.
English: Kisqali contains the active substance ribociclib, which belongs to a group of medicines called cyclin-dependent kinase (CDK) inhibitors.
Maltese: Kisqali fih is-sustanza attiva ribociclib, li jagħmel parti minn grupp ta' mediċini li jissejħu inibituri ta' kinase dipendenti fuq cyclin (CDK - cyclin-dependent kinase).
English: The most common ADRs and the most common grade 3/4 ADRs (reported at a frequency ≥20% and ≥2%, respectively) in the pooled dataset for which the frequency for Kisqali plus any combination exceeds the frequency for placebo plus any combination were infections, neutropenia, leukopenia, headache, cough, nausea, fatigue, diarrhoea, vomiting, constipation, alopecia and rash, and infections, neutropenia, leukopenia, anaemia, abnormal liver function tests, lymphopenia, hypophosphataemia and vomiting respectively.
Maltese: L-aktar ADRs komuni u l-aktar ADRs ta' grad 3/4 komuni (irrappurtati bi frekwenza ta' ≥20% u ≥2%, rispettivament) fil-ġabra tas-sett tad-data li għalihom il-frekwenza għal Kisqali flimkien ma' kwalunkwe kombinazzjoni hija ogħla mill-frekwenza għall-plaċebo flimkien ma' kwalunkwe kombinazzjoni kienu infezzjonijiet, newtropenija, lewkopenija, uġigħ ta' ras, sogħla, dardir, għeja, dijarea, rimettar, stitikezza, alopeċja u raxx, u infezzjonijiet, newtropenija, lewkopenija, anemija, testijiet tal-funzjoni tal-fwied mhux normali, limfopenija, ipofosfatemija u rimettar rispettivament.
English: Hazard Ratio = 0.568; 95% CI [0.457, 0.704] Kaplan-Meier median - Ribociclib: 25.3 months; Placebo: 16.0 months Log rank p-value = 9.63*10^(-8)
Maltese: Proporzjon ta' periklu = 0.568; 95% CI [0.457, 0.704] Il-medja skont Kaplan-Meier - Ribociclib: 25.