FrancophonIA/ELRC3.0 huggingface dataset:
English: gBRCA1/2 mutation status should be determined by an experienced laboratory using a validated test method.
Maltese: L-istatus tal-mutazzjoni gBRCA1/2 għandu jiġi ddeterminat minn laboratorju esperjenzat permezz ta' metodu tat-test validat.
English: HR (95% CI) P value (2-sided)
Maltese: HR (95% CI) Valur p (miż-żewġ naħat)
English: Therefore, known strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir) or moderate (e.g. erythromycin, diltiazem, fluconazole, verapamil) inhibitors of this isozyme are not recommended with Lynparza (see section 4.4).
Maltese: Għaldaqstant, inibituri qawwija (eż. itraconazole, telithromycin, clarithromycin, inibituri tal-protease imsaħħa b'ritonavir jew cobicistat, boceprevir, telaprevir) jew moderati (eż. erythromycin, diltiazem, fluconazole, verapamil) magħrufa ta' din l-isożima mhumiex rakkomandati ma' Lynparza (ara sezzjoni 4.4).
English: In this study 391 patients were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or placebo.
Maltese: F'dan l-istudju 391 pazjent ġew randomizzati 2:1 biex jirċievu jew Lynparza (300 mg [2 x 150 mg pilloli] darbtejn kuljum) jew plaċebo.
English: • pimozide, quetiapine - used to treat mental health problems
Maltese: • pimozide, quetiapine - użat sabiex jikkura problemi ta' saħħa mentali
English: • glibenclamide, metformin, repaglinide - used to treat diabetes
Maltese: • glibenclamide, metformin, repaglinide użati biex jikkuraw id-dijabete
English: In solutions of purified proteins, the olaparib fraction bound to albumin was approximately 56%, which was independent of olaparib concentrations.
Maltese: F'soluzzjonijiet ta' proteini purifikati, il-parti ta' olaparib imwaħħla mal-albumina kienet madwar 56%, li kienet indipendenti mill-konċentrazzjonijiet ta' olaparib.
English: Hard capsule 448 capsules (4 bottles of 112 capsules)
Maltese: Kapsula iebsa 448 kapsula (4 flixken ta' 112-il kapsula) .
English: TSST- an approximation of PFS2 (DCO 09 May
Maltese: TSSTapprossimazzjoni ta' PFS2 (DCO 09 ta' Mejju 2016)
English: Rarely, these may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Maltese: F'każijiet rari, dawn jistgħu jkunu sinjal ta' problemi aktar serji bil-mudullun bħal “sindrome majelodisplastiku” (MDS, myelodysplastic syndrome) jew “lewkimja majelojde akuta” (AML, acute myeloid leukaemia).
English: In BRCA-mutated patients (n=136) there was a statistically significant improvement in PFS, TFST and TSST.
Maltese: F'pazjenti b'mutazzjoni ta' BRCA (n=136) kemm hemm titjib statistikament sinifikanti f'PFS, TFST u TSST.
English: Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decreased and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased; 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: Anemija tinkludi termini ppreferuti (PTs, preferred terms) ta' anemija, anemija makroċitika, eritropenija, ematokrit imnaqqas, emoglobina mnaqqsa, anemija normokromika normoċitika, anemija normċotika u għadd imnaqqas taċ-ċelloli ħomor tad-demm; Newtopenija tinkludi PTs ta' agranuloċitożi, newtropenija bid-deni, għadd imnaqqas tal-granuloċiti, granuloċitopenija, newtropenija idjopatika, newtropenija, infezzjoni newtropenika, sepsi newtropenika u għadd imnaqqas tan-newtrofili; Tromboċitopenija tinkludi PTs ta' għadd imnaqqas tal-plejtlits, produzzjoni mnaqqsa tal-plejtlits, plejtlitkrit imnaqqas u tromboċitopenija; Lewkopenija tinkludi PTs ta' lewkopenija u għadd imnaqqas taċ-ċelloli bojod taddemm; Limfopenija tinkludi PTs ta' għadd imnaqqas tal-limfoċiti B, għadd imnaqqas tal-limofiċiti, limfopenija u għadd imnaqqas tal-limfoċiti T; Sogħla tinkludi PTs ta' sogħla u sogħla produttiva;
English: In this study 302 patients with a documented deleterious or suspected deleterious gBRCA mutation were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or physician's choice of chemotherapy (capecitabine 42%, eribulin 35%, or vinorelbine 17%) until progression or unacceptable toxicity.
Maltese: F'dan l-istudju 302 pazjenti b'mutazzjoni dokumentata gBRCA li tikkawża dann jew suspett ta' dann ġew randomised 2:1 biex jirċievu jew Lynparza (300 mg [2 x 150 mg pilloli] darbtejn kuljum) jew kimoterapija tal-għażla tat-tabib (capecitabine 42%, eribulin 35%, jew vinorelbine 17%) sal-progressjoni jew tossiċità mhux aċċettabbli.
English: The primary endpoint was progression-free survival (PFS) defined as time from randomisation to progression determined by investigator assessment using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death.
Maltese: L-end-point primarju kien is-sopravivenza mingħajr progressjoni (PFS) definita bħala ż-żmien mirrandomizzazzjoni għall-progressjoni determinata mill-valutazzjoni tal-investigatur bl-użu ta' Kriterji ta' Evalwazzjoni tar-Rispons f'Tumur Solidi modifikati (RECIST) 1.1, jew mewt.
English: Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common ( 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Maltese: Ilfrekwenzi tal-okkorrenza tar-reazzjonijiet avversi huma definiti bħala: komuni ħafna (≤1/10); komuni (1/100 sa <1/10); mhux komuni (≤1/1,000 sa <1/100); rari (≤1/10,000 sa <1/1000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In the olaparib-treated group, 28.4% of patients remained on treatment for ≥2 years and 14.9% for ≥5 years.
Maltese: Fil-grupp ikkurat b'olaparib, 28.4 % tal-pazjenti baqgħu fuq il-kura għal ≥sentejn u 14.9 % għal ≥5 snin.
English: There is limited experience of overdose with olaparib.
Maltese: Hemm esperjenza limitata ta' doża eċċessiva b'olaparib.
English: Olaparib 400 mg bd Placebo bd Twice daily; DCO Data cut-off; FAS Full analysis set; PFS progression-free survival
Maltese: Plaċebo bd Darbtejn kuljum; DCO Cut-off tad-data; FAS Sett ta' analiżi sħiħa;
English: Genetic testing should be conducted by an experienced laboratory using a validated test.
Maltese: Littestjar ġenetiku għandu jsir minn laboratorju esperjenzat permezz ta' test validat.
English: Secondary efficacy endpoints included PFS2; OS, TDT, TFST, TSST; and HRQoL.
Maltese: L-end-point primarju kien PFSdeterminata mill-valutazzjoni tal-investigatur bl-użu ta' RECIST 1.1. Lend-points tal-effikaċja sekondarji inkludew PFS2; OS, TDT, TFST, TSST; u HRQoL.
English: Approximately a quarter of placebo-treated patients in the BRCA-mutated subgroup (14/62; 22.6%) received a subsequent PARP inhibitor.
Maltese: Madwar kwart tal-pazjenti kkurati bi plaċebo fis-sottogrupp ta' mutazzjoni b'BRCA (14/62; 22.6%) irċevew inibitur PARP sussegwenti.
English: Adverse drug reactions are listed by MedDRA System Organ Class (SOC) and then by MedDRA preferred term in Table 1.
Maltese: Ir-reazzjonijiet avversi għal mediċina huma elenkati mis-Sistema tal-Klassifika tal-Organi MedDRA (SOC) imbagħad mit-terminu ppreferut tal-MedDRA f'Tabella 1.
English: Each hard capsule contains 50 mg of olaparib.
Maltese: Kull kapsula iebsa fiha 50 mg ta' olaparib.
English: Multipack containing 112 (2 packs of 56) film-coated tablets.
Maltese: Pakkett multiplu li fih 112 (2 pakketti ta' 56)-il pillola miksija b'rita.
English: p-value (2-sided)
Maltese: Valur p (miż-żewġ naħat)
English: In Study 19, the incidence of anaemia was 22.8% (CTCAE grade ≥3 7.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 2.9%, 5.1% and 0%, respectively; 16.2% of patients treated with olaparib needed one or more blood transfusions during the treatment.
Maltese: Fi Studju 19, l-inċidenza tal-anemija kienet 22.8 % (CTCAE grad ≥3 7.4%) u l-inċidenzi ta' interruzzjonijiet, tnaqqis u twaqqif tad-doża għall-anemija kienu 2.9%, 5.1% u 0%, rispettivament; 16.2% tal-pazjenti kkurati b'olaparib kienu jeħieġu trasfużjoni tad-demm waħda jew aktar waqt il-kura.
English: Patients were stratified based on: receipt of prior chemotherapy regimens for metastatic breast cancer (yes/no), hormone receptor (HR) positive vs triple negative (TNBC), prior platinum treatment for breast cancer (yes/no).
Maltese: Il-pazjenti ġew stratifikati abbażi ta': riċeviment ta' korsijiet ta' kimoterapija preċedenti għal kanċer tas-sider metastatiku (iva/le), pożittiv għar-riċettur tal-ormon (HR) kontra negattiv triplu (TNBC), trattamentbil-platinu minn qabel għall-kanċer tas-sider (iva/le).
English: In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (decreases) from baseline in haemoglobin was 20%, absolute neutrophils 20%, platelets 5%, lymphocytes 30% and leucocytes 20% (all % approximate).
Maltese: Fl-istudji kliniċi b'Lynparza, l-inċidenza ta' bidliet (tnaqqis) ta' CTCAE grad ≥2 millinja bażi fl-emoglobina kienet ta' 20 %, newtrofili assoluti 20 %, plejtlits 5 %, limfoċiti 30 % u lewkoċiti 20 % (kollha approssimattivi għal %).
English: bd Twice daily; OS Overall survival; DCO data cut off; CI confidence interval; TFST time from randomisation to start of first subsequent therapy or death.
Maltese: bd Darbtejn kuljum; OS sopravivenza globali; DCO cut-off tad-data; CI intervall ta' kunfidenza; TFST Żmien mir randomizzazzjoni għall-bidu tal-ewwel terapija sussegwenti jew mewt.
English: The study demonstrated a clinically relevant and statistically significant improvement in investigator assessed PFS for olaparib compared to placebo.
Maltese: L-istudju wera titjib klinikament rilevanti u statistikament sinifikanti fil-PFS ivvalutata millinvestigatur għal olaparib meta mqabbel mal-plaċebo.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jista' jaffettwa sa persuna 1 minn kull 100):
English: You will be asked to take 6 capsules (300 mg) twice a day - a total of 12 capsules each day.
Maltese: Inti se tintalab tieħu 6 kapsuli (300 mg) darbtejn kuljum - total ta' 12-il kapsula kuljum.
English: In the TNBC patient subgroup the confirmed ORR was 48% (41/86) in the olaparib arm and 12% (4/33) in the comparator arm.
Maltese: Fis-sottogrupp tal-pazjent ta' TNBC, l-ORR ikkonfermata kienet 48 % (41/86) fil-fergħa ta' olaparib u 12 % (4/33) fil-fergħa talkomparatur.
English: In patients with mild hepatic impairment (Child-Pugh classification A), AUC increased by 15% and Cmax by 13% and in patients with moderate hepatic impairment (Child-Pugh classification B), AUC increased by 8% and Cmax decreased by 13% compared with patients with normal hepatic function.
Maltese: F'pazjenti b'indeboliment tal-fwied (klassifikazzjoni Child-Pugh A), l-AUC żdiedet bi 15 % u s-Cmax bi 13 % u f'pazjenti b'indebliment tal-fwied moderat (klassifikazzjoni Child-Pugh B), l-AUC żdiedet bi 8 % u s-Cmax naqset bi 13 % meta mqabbla ma' pazjenti b'funzjoni tal-fwied normali.
English: BRCA1/2-mutated
Maltese: Mutat b'BRCA1/2
English: Adverse reactions that most commonly led to dose interruptions and/ or reductions were anaemia (13.9%), vomiting (7.1%), nausea (6.6%), fatigue/asthenia (6.1%) and neutropenia (5.8%).
Maltese: Ir-reazzjonijiet avversi li bl-aktar mod komuni wasslu għal interruzzjonijiet u/ jew għal tnaqqis fiddoża kienu anemija (13.9%), rimettar (7.1%), nawsja (6.6%), għeja/astenija (6.1%) u newtropenija (5.8%).
English: * Not controlled for multiplicity.
Maltese: * Mhux ikkontrollat għall-multipliċità.
English: • herbal remedies containing St John's Wort (Hypericum perforatum) -used mainly for depression
Maltese: • mediċini tal-ħxejjex li jkun fihom St John's Wort (Hypericum perforatum) - użati prinċipalment għad-depressjoni
English: Patients with PR at study entry had PFS HR 0.31 (95% CI 0.18, 0.52; median PFS 30.9 months on olaparib vs 8.4 months on placebo).
Maltese: Il-pazjenti b'PR mad-dħul fl-istudju kellhom PFS HR 0.31 (95% CI 0.18, 0.52; PFS medjana 30.9 xhur fuq olaparib kontra 8.4 xhur fuq plaċebo).
English: • phenytoin, carbamazepine, phenobarbital - used as a sedative or to treat fits (seizures) and epilepsy
Maltese: • phenytoin, carbamazepine, phenobarbital - użati bħala sedattiv jew biex jikkuraw aċċessjonijiet
English: No statistically significant differences were observed between olaparib and placebo in patient reported symptoms or HRQoL as measured by improvement and worsening rates in the FACT/NCCN Ovarian Symptom Index (FOSI), Trial Outcome Index (TOI) and Functional Analysis of Cancer TherapyOvarian total score (FACT-O total).
Maltese: Ma ġiet osservata ebda differenza stastikament sinifikanti bejn olaparib u plaċebo f'sintomi rrapportati mill-pazjenti jew HRQoL kif imkejjel minn rati ta' titjib u ta' aggravar fl-Indiċi tas-Sintomi tal-Ovarji FACT/NCCN (FOSI), l-Indiċi tal-Eżiti tal-Provi (TOI) u l-Analiżi Funzjonali tal-punteġġ totali talOvarji b'Terapija tal-Kanċer (FACT-O totali).
English: Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Maltese: Figura 1 Studju 19: Plott ta' Kaplan-Meier ta' PFS f'pazjenti b'mutazzjoni ta' BRCA (53% maturitàvalutazzjoni tal-investigatur)
English: Figure 6 OlympiAD: Kaplan-Meier plot of BICR PFS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (77% maturity) DCO 09 December 2016
Maltese: Plott Kaplan-Meier ta' BICR PFS f'pazjenti b'kanċer tas-sider metastatiku negattiv għall-HER2 mutat gBRCA1/2 (maturità ta' 77%) DCO 09 ta' Diċembru 2016
English: Table 3 Summary of progression-free survival and overall survival: sBRCA mutated population in Study 19
Maltese: Tabella 3 Sommarju tas-sopravivenza ħielsa mill-progressjoni u sopravivenza ġenerali: popolazzjoni b'mutazzjoni sBRCA fi Studju 19.
English: Median TSST (months)
Maltese: TSST medju (xhur)
English: The study compared the efficacy of Lynparza capsule maintenance treatment (400 mg [8 x 50 mg capsules] twice daily) taken until progression with placebo treatment in 265 (136 olaparib and 129 placebo) PSR high grade serous ovarian cancer patients who were in response (CR or PR) following completion of platinum-containing chemotherapy.
Maltese: L-istudju qabbel l-effikaċja tal-kura ta' manteniment ta' kapsula ta' Lynparza [400 mg (8 x 50 mg kapsuli) darbtejn kuljum] li ttieħdu sakemm kien hemm progressjoni bil-kura bilplaċebo f'265 (136 olaparib u 129 plaċebo) pazjent b'kanċer tal-ovarji PSR seruż ta' grad għoli li kienu f'rispons (CR jew PR) wara t-tlestija tal-kimoterapija li fiha l-platinu.
English: The incidence of dose interruptions, reductions, discontinuations due to an adverse event was 45.1%, 25.1% and 10.8%, respectively.
Maltese: L-inċidenza tal-interruzzjonijiet, tat-tnaqqis, tat-twaqqif tad-doża minħabba avveniment avvers kienet 45.1%, 25.
English: Response to prior platinum chemotherapy was complete in 47% and partial in 53% of the patients.
Maltese: Ir-rispons għal kemoterapija tal-platinum preċedenti kien komplet f'47% u parzjali fi 53% tal-pazjenti.
English: • digoxin, diltiazem, furosemide, verapamil, valsartan - used to treat heart conditions or high blood pressure
Maltese: • digoxin, diltiazem, furosemide, verapamil, valsartan użati biex jikkuraw kondizzjonijiet tal-qlab jew pressjoni għolja tad-demm
English: A ring-opened piperazin-3-ol moiety, and two mono-oxygenated metabolites (each ~10%) were the major circulating components, with one of the mono-oxygenated metabolites also being the major metabolite in the excreta (6% and 5% of the urinary and faecal radioactivity, respectively).
Maltese: Frazzjoni ta' piperazin-3-ol b'ċirku miftuħ, u żewġ metaboliti monoossiġenati (kull wieħed ~10%) kienu l-komponenti maġġuri li jiċċirkolaw, b'wieħed mill-metaboliti monoossiġenati li kien ukoll il-metabolit maġġuri fl-eskrezzjoni (6% u 5% tar-radjuattività fl-awrina u fl-ippurgar, rispettivament).
English: In the placebo arm 49% of patients had received only 2 prior lines with 51% receiving 3 or more prior lines of treatment.
Maltese: Fil-fergħa tal-plaċebo 49 % talpazjenti rċivew biss 2 linji ta' kura preċedenti b'51 % li rċivew 3 linji ta' kura preċedenti jew aktar.
English: Table 3 Summary of primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Maltese: Tabella 3 Sommarju tal-eżiti tal-objettivi primarji għall-pazjenti b'kanċer tal-ovarji PSR gBRCA1/2m f'SOLO2
English: The study compared the efficacy of olaparib maintenance treatment taken until progression with no maintenance treatment in 265 (136 olaparib and 129 placebo) PSR serous ovarian cancer patients who were in response (CR [complete response] or PR [partial response]) confirmed as per RECIST and/or as per CA-125 criteria as defined by Gynecologic Cancer InterGroup (GCIG) (at least a 50% reduction in CA-125 levels from the last pre-treatment sample, confirmed 28 days later) following completion of two or more previous platinum-containing chemotherapy.
Maltese: L-istudju qabbel l-effikaċja ta' kura ta' manteniment b'olaparib meħuda sal-progressjoni mingħajr kura ta' manteniment f'265 (136 olaparib u 129 placebo) pazjent b'kanċer tal-ovarji seruż PSR li kienu f'rispons (CR [rispons komplet] jew PR [rispons parzjali]) ikkonfermat bħala skont RECIST u/jew skont il-kriterji CA-125 kif definiti millIntergrupp tal-Kanċer Ġinekoloġiku (GCIG) (tal-anqas tnaqqis ta' 50% fil-livelli ta' CA-125 millaħħar kampjun ta' qabel il-kura, ikkonfermat 28 jum wara) wara t-tlestija ta' żewġ kimoterapiji preċedenti jew aktar li fihom platinum.
English: Ovarian cancer was the primary tumour in 85% of the patients.
Maltese: Il-kanċer tal-ovarji kien ittumur primarju f'85 % tal-pazjenti.
English: • a certain type of breast cancer (BRCA-mutated, HER2-negative) which has spread beyond the original tumour.
Maltese: • ċertu tip ta' kanċer tas-sider (mutat BRCA, negattiv għall-HER2) li jkun infirex aktar mittumur oriġinali.
English: • The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day - a total of 4 tablets each day.
Maltese: • Id-doża rakkomandata tas-soltu hija ta' 300 mg (2 x 150 mg pilloli) darbtejn kuljum - total ta' 4 pilloli kuljum.
English: Figure 8 OlympiAD: Kaplan-Meier plot of OS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (64% maturity) DCO 25 September 2017
Maltese: Plot Kaplan-Meier ta' OS f'pazjenti b'kanċer tas-sider metastatiku negattiv għall-HER2 mutat gBRCA1/2 (maturità ta' 64%) DCO 25 ta' Settembru 2017
English: Figure 1 SOLO1: Kaplan-Meier plot of PFS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (51% maturity - investigator assessment)
Maltese: Figura 1 SOLO1: Plott ta' Kaplan-Meier ta' PFS f'pazjenti li għadhom kif jiġu dijanjostikati b'kanċer tal-ovarji avvanzat BRCA1/2m (51% maturità - valutazzjoni mill-investigatur)
English: Up to 20, 37 and 20 metabolites were detected in plasma, urine and faeces, respectively, the majority of them representing < 1% of the dosed material.
Maltese: Sa 20, 37 u 20 metabolit ġew identifikati fil-plażma, fl-awrina u fl-ippurgar, rispettivament, ilmaġġoranza tagħhom jirrappreżentaw <1% tal-materjal dożat.
English: In the olaparib-treated group, 23.5% (n=32/136) of patients remained on treatment for ≥2 years as compared with 3.9% (n=5/128) of the patients on placebo.
Maltese: Fil-grupp ikkurat b'olaparib, 23.5 % (n=32/136) tal-pazjenti baqgħu fuq il-kura għal ≥sentejn kif imqabbel ma' 3.9 % (n=5/128) tal-pazjenti fuq il-plaċebo.
English: Frequency of All CTCAE grades
Maltese: Frekwenza tal-gradi CTCAE kollha
English: (events/patients)
Maltese: (avvenimenti/pazje nti) (%)
English: Lynparza is for oral use.
Maltese: Lynparza huwa għal użu orali.
English: Table 4 Summary of key secondary objective outcomes for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Maltese: Tabella 4 Sommarju tal-eżiti objettivi sekondarji ewlenin għall-pazjenti b'kanċer tal-ovarji PSR gBRCA1/2m f'SOLO2
English: In Study 19, 20 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
Maltese: Fi Studju 19, ġew identifikati 20 pazjent b'tumur b'mutazzjoni ta' BRCA somatiku (mutazzjoni fittumur iżda tat-tip selvaġġ fil-linja ġerminali).
English: Common Fatigue (including asthenia)
Maltese: Komuni Għeja (inkluż astenija)
English: In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (decreases) from baseline in haemoglobin was 20%, absolute neutrophils 20%, platelets 5%, lymphocytes 30% and leucocytes 20% (all % approximate).
Maltese: Flistudji kliniċi b'Lynparza, l-inċidenza ta' bidliet ta' CTCAE grad ≤2 (tnaqqis) mil-linja bażi flemoglobina kienet ta' 20 %, newtrofili assoluti 20 %, pjastrini 5 %, limfoċiti 30 % u lewkoċiti 20 % (kollha viċin %).
English: The median PFS improvement was 6.9 months over placebo for olaparib-treated patients (HR 0.18; 95% CI 0.10-0.31; p<0.00001; median 11.2 months versus 4.3 months).
Maltese: It-titjib medju fil-PFS kien 6.9 xhur aktar minn plaċebo għal pazjenti kkurati b'olaparib (HR 0.18; 95% CI 0.10-0.31; p<0.00001; medja ta' 11.2 xhur meta mqabbel ma' 4.3 xhur).
English: Distribution The in vitro protein binding is approximately 82% at clinically relevant concentrations of 10 µg/mL.
Maltese: It-twaħħil tal-proteina in vitro huwa madwar 82% bil-konċentrazzjonijiet klinikament relevanti ta' 10 µg/mL.
English: Slovenská republika AstraZeneca AB, o.z.
Maltese: Deutschland AstraZeneca GmbH
English: All patients comprises of the following subgroups: BRCA1/2-mutated, BRCA1/2 wt/VUS and BRCA1/2 status unknown (11 patients with status unknown, not shown as a separate subgroup in table).
Maltese: Il-pazjenti kollha tinkludi s-sottogruppi li ġejjin: mutat b'BRCA1/2, BRCA1/2 wt/VUS u status ta' BRCA1/2 mhux magħruf (11-il pazjent bi status mhux magħruf, mhux murija bħala sottogrupp separat fit-tabella).
English: In the olaparib arm 55% of the patients had only 2 prior lines of treatment with 45% receiving 3 or more prior lines of treatment.
Maltese: Fil-fergħa ta' olaparib 55 % tal-pazjenti kellhom biss 2 linji ta' kura preċedenti b'45 % li rċivew 3 linji ta' kura preċedenti jew aktar.
English: Information on other ingredients in this medicine This medicine contains less than 1 mmol sodium (23 mg) per 100 mg or 150 mg tablet, that is to say essentially “sodium-free”.
Maltese: Informazzjoni dwar ingredjenti oħra f'din il-mediċina Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull pillola ta' 100 mg jew 150 mg, jiġifieri hija essenzjalment “ħieles mis-sodium”.
English: In the olaparib and placebo arms, 17% and 20% of patients had prior bevacizumab, respectively.
Maltese: Fil-fergħat ta' olaparib u tal-plaċebo, 17 % u 20 % talpazjenti rċivew bevacizumab preċedenti, rispettivament.
English: • colchicine - used to treat gout
Maltese: • colchicine - użat sabiex jikkura l-gotta