FrancophonIA/ELRC3.0 huggingface dataset:
English: At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the HR comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
Maltese: Fl-analiżi finali ta' OS (data ta' limitu (DCO, data cut off) 9 ta' Mejju 2016), għal OS b'maturità ta' 79 %, l-HR meta jitqabbel olaparib ma' plaċebo kien 0.73 (95% CI 0.55-0.95; p=0.02138 (ma laħaqx il-livell ta' sinifikanza definit minn qabel ta' <0.0095); medjan 29.8 xhur olaparib kontra 27.8 xhur plaċebo).
English: Lynparza capsules (50 mg) should not be substituted for Lynparza tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Maltese: Lynparza kapsuli (50 mg) m'għandhomx jiġu sostituti b'Lynparza pilloli (100 mg u 150 mg) fuq ilbażi ta' milligramma għal milligramma minħabba differenzi fid-dożaġġ u l-bijodisponibbiltà ta' kull formulazzjoni.
English: Gender (%) Female Male
Maltese: Sess (%)
English: Lynparza 50 mg hard capsules olaparib
Maltese: Lynparza 50 mg kapsuli ibsin olaparib
English: The study met its primary objective demonstrating a statistically significant improvement in investigator assessed PFS for olaparib compared with placebo with a HR of 0.30 (95% CI 0.22-0.41; p<0.0001; median 19.1 months olaparib vs 5.5 months placebo).
Maltese: L-istudju ssodisfa l-objettiv primarju tiegħu biex wera titjib statistikament sinifikanti fil-PFS ivvalutata mill-investigatur għal olaparib meta mqabbel mal-plaċebo bi HR ta' 0.30 (95% CI 0.220.41; p<0.0001; 19.1 xhur medjana olaparib vs 5.5 xhur plaċebo).
English: bd Twice daily; PFS Progression free survival
Maltese: bd Darbtejn kuljum; PFS Sopravivenza mingħajr progressjoni
English: Previous platinum-based therapy in (neo)adjuvant setting metastatic setting in (neo)adjuvant and metastatic setting 3 (1) Previous anthracycline treatment in (neo) adjuvant setting metastatic setting
Maltese: Terapija preċedenti bbażata fuq ilplatinu (%) fl-ambjent (neo)aġġuvanti ambjent metastatiku fl-ambjent (neo)aġġuvanti u metastatiku
English: • Each Lynparza 100 mg film-coated tablet contains 100 mg olaparib.
Maltese: • Kull Lynparza 100 mg pillola miksija b'rita fiha 100 mg olaparib.
English: • Each Lynparza 150 mg film-coated tablet contains 150 mg olaparib.
Maltese: • Kull Lynparza 150 mg pillola miksija b'rita fiha 150 mg olaparib.
English: Myelodysplastic syndrome/Acute myeloid leukaemia The overall incidence of myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) in patients treated in clinical trials with Lynparza monotherapy, including long-term survival follow-up, was <1.5% and the majority of events had a fatal outcome.
Maltese: Sindrome majelodisplastiku/Lewkimja majelojde akuta L-inċidenza totali ta' sindrome majelodisplastiku/lewkimja majelojde akuta (MDS/AML) f'pazjenti kkurati fil-provi kliniċi b'monoterapija b'Lynparza, inkluż segwitu ta' sopravivenza fit-tul, kienet ta' <1.5% u l-maġġoranza tal-avvenimenti kellhom riżultat fatali.
English: Consistent results were observed in all predefined patient subgroups (see Figure 7).
Maltese: Ġew osservati riżultati konsistenti fis-sottogruppi tal-pazjenti kollha definiti minn qabel (ara Figura 7).
English: The efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib (see sections 4.4 and 4.6).
Maltese: L-effikaċja ta' xi kontraċettivi ormonali tista' titnaqqas jekk jingħataw flimkien ma' olaparib (ara wkoll sezzjonijiet 4.4 u 4.6).
English: In rats, minimal degenerative effects on gastrointestinal tract were also noted.
Maltese: Fil-firien, ġew innutati wkoll effetti deġenerattivi minimi fuq l-apparat gastrointestinali.
English: The investigator assessment of PFS was consistent with a blinded independent central radiological review of PFS. At the final analysis (DCO 9 May 2016), the time from randomisation to start of first subsequent therapy or death (TFST) was 9.4 months longer for olaparib-treated patients (HR 0.33; 95% CI 0.22-0.49; p<0.00001; median 15.6 months versus 6.2 months).
Maltese: Fl-analiżi finali (DCO 9 ta' Mejju 2016), iż-żmien mir-randomizzazzjoni sal-bidu tal-ewwel terapija sussegwenti jew mewt (TFST) kien 9.4 xhur itwal għal pazjenti kkurati b'olaparib (HR 0.33; 95% CI 0.22-0.49; p<0.00001; medja ta' 15.6 xhur meta mqabbel ma' 6.2 xhur).
English: In the olaparib and placebo arms, 6% and 5% of patients had prior bevacizumab, respectively.
Maltese: Fil-fergħat ta' olaparib u tal-plaċebo, 6 % u 5 % tal-pazjenti rċivew bevacizumab preċedenti, rispettivament.
English: Therefore, caution should be exercised when sensitive CYP3A substrates or substrates with a narrow therapeutic margin (e.g. simvastatin, cisapride, cyclosporine, ergot alkaloids, fentanyl, pimozide, sirolimus, tacrolimus and quetiapine) are combined with olaparib.
Maltese: Għalhekk, għandha tiġi eżerċitata l-kawtela meta substrati sensittivi ta' CYP3A jew substrati b'marġni terapewtika dejqa (eż. simvastatin, cisapride, cyclosporine, alkalojdi tal-ergotina, fentanyl, pimozide, sirolimus, tacrolimus u quetiapine) jiġu kkombinati ma' olaparib.
English: The other ingredients (excipients) are:
Maltese: Numru ta' rispondenti oġġettivi:
English: However, there was a slight reduction in embryofoetal survival.
Maltese: Madankollu, kemm hemm ftit tnaqqis fis-sopravivenza embrijofetali.
English: Following oral administration of olaparib via the tablet formulation (2 x 150 mg), absorption is rapid with median peak plasma concentrations typically achieved 1.5 hours after dosing.
Maltese: Wara għoti orali ta' olaparib permezz tal-formulazzjoni tal-pillola (2 x 150 mg), l-assorbiment kien rapidu bil-konċentrazzjonijiet massimi fil-plażma medjani li ntlaħqu tipikament 1.5 sigħat wara ddożaġġ.
English: A summary of the primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2 is presented in Table 3 and Figure 3.
Maltese: Sommarju tal-eżiti tal-objettivi primarji għall-pazjenti b'kanċer tal-ovarji PSR gBRCA1/2m f'SOLO2 huwa ppreżentat f'Tabella 3 u f'Figura 3.
English: Interval debulking surgery was performed in 35% of the patients and of these 82% had no macroscopic residual disease reported.
Maltese: Kirurġija tat-tnaqqis tal-volum tat-tumur ta' intervall saret f'35% tal-pazjenti u minn dawn 82% ma kellhom l-ebda marda ta' residwi makroskopika rrappurtata.
English: The investigator assessment of PFS was supported with a blinded independent central radiological (BICR) review of PFS. At the time of PFS analysis, interim OS data were immature (21%), with HR 0.95 (95% CI 0.60, 1.53; p-value=0.9).
Maltese: Meta saret lanaliżi tal-PFS, data tal-OS interim (21%) kienet immatura b'HR 0.95 (95% CI 0.60, 1.53; pvalue=0.9).
English: bd Twice daily; DCO Data cut off; FAS Full analysis set; OS Overall survival
Maltese: bd Darbtejn kuljum; DCO Cut-off tad-data; FAS Sett ta' analiżi sħiħa; OS Sopravivenza globali
English: A summary of key secondary objective outcomes for patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19 is presented in Table 6 and for all patients in Study 19 in Table 6 and Figure 5.
Maltese: Sommarju tal-eżiti objettivi sekondarji ewlenin għall-pazjenti b'kanċer tal-ovarji PSR mutat b'BRCA1/2 u BRCA1/2 wt/VUS fi Studju 19 huwa ppreżentat f'Tabella 6 u għall-pazjenti kollha fi Studju 19 f'Tabella 6 u f'Figura 5.
English: Vomiting, Diarrhoea, Nausea, Dyspepsia, Upper abdominal pain
Maltese: Rimettar, Dijarea, Dispepsja, Dardir, Uġigħ fil-parti ta' fuq tal-addome
English: Lynparza 50 mg hard capsules
Maltese: Lynparza 50 mg kapsuli ibsin
English: The study compared the efficacy of Lynparza maintenance treatment (300 mg [2 x 150 mg tablets] twice daily) taken until progression with placebo treatment in 295 patients with high-grade serous or endometrioid PSR ovarian cancer (2:1 randomisation: 196 olaparib and 99 placebo) who were in response (CR or PR) following completion of platinum-containing chemotherapy.
Maltese: L-istudju qabbel l-effikaċja ta' kura ta' manteniment b'Lynparza [300 mg (2 x 150 mg pilloli) darbtejn kuljum] li jittieħdu sakemm ikun hemm progressjoni bil-kura bil-plaċebo f'295 pazjent b'kanċer ta' grad għoli ovariku PSR seruż jew endometrojde (randomizzazzjoni 2:1). 196 olaparib u 99 plaċebo) li kienu f'rispons (CR jew PR) wara t-tlestija ta' kimoterapija li fiha l-platinu.
English: Lynparza monotherapy has been associated with adverse reactions generally of mild or moderate severity (CTCAE grade 1 or 2) and generally not requiring treatment discontinuation.
Maltese: Il-monoterapija b'Lynparza ġiet assoċjata ma' reazzjonijiet avversi ġeneralment ta' severità ħafifa jew moderata (CTCAE grad 1 jew 2) u ġeneralment li ma jeħtiġux it-twaqqif tal-kura.
English: bd Twice daily; PFS progression-free survival; DCO data cut off; CI confidence interval; NR not reached.
Maltese: PFS sopravivenza mingħajr progressjoni; DCO cut-off tad-data; CIintervall ta'
English: White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.
Maltese: Kapsula iebsa, bajda, opaka, ta' daqs 0, immarkata b'“OLAPARIB 50 mg” u l-logo AstraZeneca b'linka sewda.
English: The pharmacokinetics of olaparib at the 400 mg twice daily capsule dose are characterised by an apparent plasma clearance of ~8.6 L/h, an apparent volume of distribution of ~167 L and a terminal half-life of 11.9 hours.
Maltese: Il-farmakokinetika ta' olaparib b'doża ta' kapsula ta' 400 mg darbtejn kuljum hija kkaratterizzata mittneħħija apparenti mill-plażma ta' ~8.6
English: The safety profile is based on pooled data from 1,826 patients with solid tumours treated with Lynparza monotherapy in clinical trials at the recommended dose.
Maltese: Il-profil tas-sigurtà huwa bbażat fuq data miġbura minn 1,826 pazjent b'tumuri solidi kkurati b'monoterapija b'Lynparza fil-provi kliniċi bid-doża rakkomandata.
English: Table 6 Summary of key secondary objective outcomes for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Maltese: Tabella 6 Sommarju tal-eżiti objettivi sekondarji ewlenin għall-pazjenti kollha u għall-pazjenti b'kanċer tal-ovarji PSR mutat b'BRCA1/2 u BRCA1/2 wt/VUS fi Studju 19
English: The proportion of patients who progressed within 6 months of the last dose of platinum-based chemotherapy was 3.5% for olaparib and 8.4% for placebo.
Maltese: Il-proporzjon ta' pazjenti li pprogressaw fi żmien 6 xhur mill-aħħar doża ta' kimoterapija bbażata fuq il-platinu kien 3.5 % għal olaparib u 8.4 % għal plaċebo.
English: The study met its primary objective demonstrating a statistically significant improvement in PFS for olaparib compared with placebo in the overall population with a HR of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib vs 4.8 months placebo).
Maltese: L-istudju laħaq l-objettiv primarju tiegħu u wera titjib fil-PFS statistikament sinifikanti għal olaparib meta mqabbel ma' plaċebo fil-popolazzjoni globali bi proporzjon ta' periklu (HR) ta' 0.35 (95% CI 0.25-0.49; p<0.00001; medjan 8.4 xhur olaparib kontra 4.8 xhur plaċebo).
English: Mean corpuscular volume elevation
Maltese: Elevazzjoni f'volum korpuskulari medju
English: Distribution The in vitro plasma protein binding is approximately 82% at 10 µg/mL which is approximately Cmax.
Maltese: Distribuzzjoni L-irbit tal-proteina tal-plażma in vitro huwa madwar 82 % b'10 µg/mL li huwa madwar Cmax.
English: Secondary efficacy endpoints included OS (overall survival), DCR (disease control rate) defined as confirmed CR/PR + SD (stable disease), HRQoL (health related quality of life), and disease related symptoms.
Maltese: Il-punti ta' tmiem fleffikaċja sekondarja kienu jinkludu OS (sopravivenza ġenerali), DCR (rata ta' kontroll tal-marda) iddefinita bħala CR/PR + SD (marda stabbli) ikkonfermati, HRQoL (kwalità tal-ħajja relatata massaħħa), u sintomi relatati mal-marda.
English: Pre-planned subgroup analysis by BRCA-mutation status identified patients with BRCA-mutated ovarian cancer (n=136, 51.3%) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
Maltese: L-analiżi tas-sottogruppi ppjanata minn qabel mill-istatus tal-mutazzjoni ta' BRCA identifikat pazjenti b'kanċer tal-ovarji b'mutazzjoni ta' BRCA (n=136, 51.3%) bħala s-sottogrupp li ta l-akbar benefiċċju kliniku mill-monoterapija ta' manteniment b'olaparib.
English: DOR - DCO 09 December 2016
Maltese: DOR - DCO 09 ta' Diċembru 2016
English: Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
Maltese: Raxx tinkludi PTs ta' raxx esfoljattiv, eritema ġeneralizzata, raxx, raxx eritematuż, raxx ġeneralizzat, raxx makulari, raxx makulopapulari, raxx papulari u raxx bil-ħakk; Sensittività eċċessiva tinkludi PTs ta' sensittività eċċessiva għal mediċina u sensittività eċċessiva u; Dermatite tinkludi PTs ta' dermatite, dermatite allerġika u dermatite esfoljattiva.
English: PFS2 (40% maturity) Number of events: Total number of patients (%)
Maltese: PFS2 (31% maturità) Numru ta' avvenimenti:
English: Lynparza can be administered in patients with mild renal impairment (creatinine clearance 51 to 80 ml/min) with no dose adjustment.
Maltese: Lynparza jista' jingħata f'pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina 51 sa 80 ml/min) bl-ebda aġġustament fid-doża.
English: Exploratory analyses of TFST and TSST were also performed.
Maltese: Saru wkoll analiżijiet esploratorji ta' TFST u TSST.
English: Vomiting events led to interruption in 10% of olaparib-treated patients; no olaparib-treated patients experienced a vomiting event leading to dose reduction.
Maltese: Avvenimenti ta' rimettar waslu għal interruzzjoni f'10 % tal-pazjenti kkurati b'olaparib; l-ebda pazjent ikkurat b'olaparib ma esperjenza avveniment ta' rimettar li wassal għal tnaqqis fid-doża.
English: Most patients were ECOG performance status 0 (81%), there are no data in patients with performance status 2 to 4.
Maltese: Ħafna mill-pazjenti kellhom status tal-prestazzjoni ECOG 0 (81 %), m'hemmx dejta f'pazjenti bi status tal-prestazzjoni 2 sa 4.
English: Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets olaparib
Maltese: Lynparza 100 mg pilloli miksijin b'rita Lynparza 150 mg pilloli miksijin b'rita olaparib
English: BRCA mutation status should be determined by an experienced laboratory using a validated test method (see section 5.1).
Maltese: L-istatus tal-mutazzjoni ta' BRCA għandu jiġi stabbilit minn laboratorju esperjenzat bl-użu ta' metodu ta' ttestjar ivvalidat (ara sezzjoni 5.1).
English: In the olaparib arm 44% of the patients had only 2 prior lines of treatment with 56% receiving 3 or more prior lines of treatment.
Maltese: Fil-fergħa ta' olaparib 44 % tal-pazjenti kellhom biss 2 linji ta' kura preċedenti b'56 % li rċivew 3 linji ta' kura preċedenti jew aktar.
English: In clinical studies with the tablet formulation, the incidence of anaemia adverse reactions was 38.8% (CTCAE grade ≥3 17.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 15.7%, 10.8% and 1.9%, respectively; 20.9% of patients treated with olaparib needed one or more blood transfusions.
Maltese: Fl-istudji kliniċi bil-formulazzjoni tal-pillola, l-inċidenza ta' reazzjonijiet avversi tal-anemija kienet 38.8 % (CTCAE grad ≥ 3 17.4%) u l-inċidenzi ta' interruzzjonijiet, tnaqqis fid-doża u twaqqif tad-doża għal anemija kienu 15.
English: In a post-hoc analysis of the subgroup of patients that had not progressed on chemotherapy other than platinum, the median PFS in the olaparib arm (n=22) was 8.3 months (95% CI 3.1-16.7) and 2.8 months (95% CI 1.4-4.2) in the chemotherapy arm (n=16) with a HR of 0.54 (95% CI 0.24-1.23).
Maltese: F'analiżi post-hoc tas-sottogrupp ta' pazjenti li ma kinux ipprogressaw fuq il-kimoterapija minbarra lplatinu, il-PFS medjana fil-fergħa ta' olaparib (n=22) kienet 8.3 xhur (95% CI 3.1-16.7) u 2.8 xhur (95% CI 1.4-4.2) fil-fergħa tal-kimoterapija (n=16) b'HR ta' 0.54 (95% CI 0.24-1.23). Madankollu, in-numru ta' pazjenti kien limitat wisq biex isiru konklużjonijiet sinifikanti dwar l-effikaċja f'dan issottogrupp.
English: A total of 32 (23.5%) patients received treatment for ≥2 years in the olaparib group compared with 5 (3.9%) patients in the placebo group.
Maltese: Total ta' 32 (23.5%) pazjent ingħataw kura għal ≥sentejn fil-grupp ta' olaparib meta mqabbel ma' 5 (3.9%) pazjenti fil-grupp ta' plaċebo.
English: Secondary efficacy endpoints included time from randomisation to second progression or death (PFS2), overall survival (OS), time from randomisation to discontinuation of treatment or death (TDT), time from randomisation to first subsequent anticancer therapy or death (TFST) and health related quality of life (HRQoL).
Maltese: L-end-points taleffikaċja sekondarji inkludew żmien mir-randomizzazzjoni għat-tieni progressjoni jew għall-mewt (PFS2), sopravivenza globali (OS), żmien mir-randomizzazzjoni għat-twaqqif tal-kura jew għall-mewt (TDT), żmien mir-randomizzazzjoni għall-ewwel terapija kontra l-kanċer sussegwenti jew għall-mewt (TFST) u kwalità tal-ħajja relatata mas-saħħa (HRQoL).
English: Copovidone
Maltese: Pożoloġija
English: Enrolment did not require evidence of BRCA1/2 mutation (BRCA mutation status for some patients was determined retrospectively).
Maltese: Ir-reġistrazzjoni ma kinitx teħtieġ evidenza ta' mutazzjoni BRCA1/2 (L-istatus ta' mutazzjoni BRCA għal xi pazjenti ġie stabbilit retrospettivament).
English: The limited data for these somatic tumour BRCA (sBRCA) mutated patients show that fewer patients on olaparib reported progression events or death events compared with placebo (Table 3).
Maltese: Id-data limitata għal dawn il-pazjenti b'tumur b'mutazzjoni BRCA somatiku (sBRCA) turi li inqas pazjenti fuq olaparib irrappurtaw avvenimenti ta' progressjoni jew avvenimenti ta' mewt meta mqabbel ma' plaċebo (Tabella 3).
English: The recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a strong CYP3A inhibitor or 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Maltese: It-tnaqqis rakkomandat fiddoża ta' Lynparza huwa sa 150 mg li jittieħdu darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 300 mg) b'inibitur CYP3A b'saħħtu jew 200 mg li jittieħdu darbtejn kuljum (ekwivalenti għal doża totali ta' 400 mg) b'inibitur CYP3A moderat (ara sezzjonijiet 4.2 u 4.4).
English: Response to prior platinum chemotherapy was complete in 45% and partial in 55% of the patients.
Maltese: Ir-rispons għal kemoterapija tal-platinum preċedenti kien komplet f'45% u parzjali f'55% tal-pazjenti.
English: Using the same assay, the fraction bound to alpha-1 acid glycoprotein was 29% at 10 µg/mL with a trend of decreased binding at higher concentrations.
Maltese: Bl-użu tal-istess assaġġ, il-frazzjoni marbuta mal-glikoproteina alpha-1-acid kienet 29 % b'10 µg/mL b'tendenza ta' rbit imnaqqas b'konċentrazzjonijiet ogħla.
English: bd Twice daily; PFS progression-free survival; CI confidence interval
Maltese: bd Darbtejn kuljum; PFS sopravivenza mingħajr progressjoni; CI intervall ta' kunfidenza
English: Uncommon Dizziness, Headache
Maltese: Kontraċettiv, tqala u treddigħ
English: On multiple dosing, an AUC accumulation ratio of 1.8 was observed and PK appeared to be time-dependent to a small extent.
Maltese: Fuq dożaġġ multiplu, ġie osservat proporzjon ta' akkumulazzjoni ta' AUC ta' 1.8 u sa ċertu punt il-PK deher li huwa dipendenti fuq iż-żmien.
English: Date of first authorisation: 16 December 2014 Date of last renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Diċembru 2014
English: At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the hazard ratio comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
Maltese: Fl-analiżi finali ta' OS (cut off tad-data (DCO, data cut off) 9 ta' Mejju 2016), għal OS b'maturità ta' 79 % il-proporzjon ta' periklu li jqabbel olaparib mal-plaċebo kien 0.73 (95% CI 0.55-0.95; p=0.02138 (ma ssodisfax il-livell ta' sinifikanza speċifikat minn qabel ta' <0.
English: All patients comprises of the following subgroups: BRCA1/2-mutated, BRCA1/2 wt/VUS and BRCA1/2 status unknown
Maltese: Mutat b'BRCA1/2 Mutat b'BRCA1/2 wt/VUS
English: Anaemia was the most common CTCAE grade ≥3 adverse reaction reported in clinical studies.
Maltese: L-anemija kienet l-aktar reazzjoni avversa ta' CTCAE grad ≤ 3 irrappurtata fl-istudji kliniċi.
English: In patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min), AUC increased by 44% and Cmax by 26% compared with patients with normal renal function.
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat (tneħħija tal-kreatinina 31 sa 50 ml/min), l-AUC żdiedet b'44 % u s-Cmax b'26 % meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: Lynparza is provided in HDPE plastic bottles containing 112 hard capsules.
Maltese: Lynparza hu pprovdut fi fliexken tal-plastik HDPE li fihom 112-il kapsula iebsa.
English: When dosed orally to rats, olaparib induced micronuclei in bone marrow.
Maltese: Meta dożat oralment lill-firien, olaparib induċi mikronuklei fil-mudullun.
English: In the placebo arm 61% of patients had received only 2 prior lines with 39% receiving 3 or more prior lines of treatment.
Maltese: Fil-fergħa talplaċebo 61 % tal-pazjenti kienu rċivew biss 2 linji preċedenti b'39 % li rċivew 3 linji ta' kura preċedenti jew aktar.
English: Haematological toxicity has been reported in patients treated with Lynparza, including clinical diagnoses and/or laboratory findings of generally mild or moderate (CTCAE grade 1 or 2) anaemia, neutropenia, thrombocytopenia and lymphopenia.
Maltese: Ġiet irrapportata tossiċità ematoloġika f'pazjenti kkurati b'Lynparza, inkluż dijanjosi klinika u/jew sejbiet tal-laboratorju ta' anemija, tromboċitopenja, newtropenja u limfopenja ġeneralment ħfief jew moderati (grad CTCAE 1 jew 2).
English: Most patients were ECOG performance status 0 (77%), there are no data in patients with performance status 2 to 4.
Maltese: Ħafna millpazjenti kellhom status tal-prestazzjoni ECOG 0 (77 %), ma kien hemm l-ebda dejta f'pazjenti bi status tal-prestazzjoni 2 sa 4.
English: Anaemia and other haematological toxicities were generally low grade (CTCAE grade 1 or 2), however, there were reports of CTCAE grade 3 and higher events.
Maltese: Anemija u tossiċitajiet ematoloġiċi oħrajn huma ġeneralment ta' grad baxx (CTCAE grad 1 jew 2), madankollu, hemm rapporti ta' avvenimenti ta' CTCAE grad 3 u ogħla.
English: OS analysis in patients with no prior chemotherapy for metastatic breast cancer indicated benefit in these patients with a HR of 0.45 (95% CI 0.27-0.77), while for further lines of therapy HR exceeded 1.
Maltese: Analiżi tal-OS f'pazjenti bl-ebda kimoterapija preċedenti għal kanċer tas-sider metastatiku indikat benefiċċju f'dawn il-pazjenti b'HR ta' 0.45 (95% CI 0.27-0.77), filwaqt għal linji ulterjuri ta' terapija, l-HR qabeż 1.
English: Mechanism of action and pharmacodynamic effects Olaparib is a potent inhibitor of human poly (ADP-ribose) polymerase enzymes (PARP-1, PARP-2, and PARP-3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo either as a standalone treatment or in combination with established chemotherapies.
Maltese: Olaparib huwa inibitur qawwi tal-enzimi tal-poly (ADP-ribose) polymerase (PARP-1, PARP-2 u PARP-3) tal-bniedem, u ntwera li jinibixxi t-tkabbir ta' linji ta' ċelluli tat-tumur magħżula in vitro u tkabbir tat-tumur in vitro jew bħala kura waħedha jew flimkien ma' kimoterapiji stabbiliti.