FrancophonIA/ELRC3.0 huggingface dataset:
English: Sixty-three percent (63%) of the patients had upfront debulking surgery and of these the majority (75%) had no macroscopic residual disease.
Slovenian: Večina bolnic (78 %) je imela stanje zmogljivosti po ECOG 0, podatkov pri bolnicah s stanjem zmogljivosti od 2 do 4 ni. Triinšestdeset odstotkov (63 %) bolnic je imelo predhodno operacijo za zmanjšanje tumorja in večina od teh (75 %) ni imela makroskopsko vidnih ostankov bolezni.
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).
Slovenian: Študija je dosegla svoj primarni cilj in je dokazala statistično značilno izboljšanje raziskovalčeve ocene PFS z olaparibom v primerjavi s placebom z ROg 0,30 (95 % IZ 0,22 do 0,41, p < 0,0001, mediana 19,1 mesecev z olaparibom in 5,5 meseca s placebom).
English: Patients with BRCA1/2 mutations were identified from germline testing in blood via a local test or by central testing at Myriad.
Slovenian: Bolnike z mutacijami gena BRCA1/2 so identificirali s testiranjem germinalne linije v krvi bodisi z lokalnim testom bodisi s centralnim testom na Myriad.
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).
Slovenian: Ob končni analizi (datum zamejitve podatkov (DCO - data cut off) 9. maj 2016) je bilo za celokupno preživetje ob 79 % zrelosti razmerje ogroženosti med olaparibom in placebom 0,73 (95 % IZ 0,55 do 0,95, p = 0,02138 [ni doseglo vnaprej določene ravni značilnosti < 0,0095], mediana 29,8 meseca z olaparibom in 27,8 meseca s placebom).
English: If a further dose reduction is required, then reduction to 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) is recommended.
Slovenian: Če je potrebno še dodatno zmanjšanje odmerka, je priporočljivo zmanjšanje na 200 mg (dve 100-mg tableti) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg).
English: HR
Slovenian: ND
English: There was no evidence of disease at study entry (CR), defined by the investigator as no radiological evidence of disease and cancer antigen 125 (CA-125) within normal range, in 73% and 77% of patients in the olaparib and placebo arms, respectively.
Slovenian: 73 % bolnic v skupini z olaparibom in 77 % bolnic v skupini s placebom ni imelo nobenih dokazov bolezni ob vstopu v študijo (CR), opredeljeno kot odsotnost radioloških znakov bolezni po raziskovalčevi oceni in raven antigena CA-125 v normalnem območju.
English: For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 300 mg twice daily (equivalent to a total daily dose of 600 mg) (see section 5.2).
Slovenian: Priporočeni odmerek zdravila Lynparza za bolnice z zmerno okvaro ledvic (očistek kreatinina 31 do 50 ml/min) je 300 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 600 mg) (glejte poglavje 5.2).
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).
Slovenian: Priporočeno zmanjšanje odmerka zdravila Lynparza je 150 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg) v primeru uporabe z močnim zaviralcem CYP3A ali 200 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg) v primeru uporabe z zmernim zaviralcem CYP3A (glejte poglavji 4.2 in 4.4).
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.
Slovenian: Povzetek izidov ključnih sekundarnih ciljev za PSR bolnice z rakom jajčnikov in z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19 je prikazan v preglednici 6, za vse bolnice v študiji 19 pa v preglednici 6 in na sliki 5.
English: Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a test performed by Foundation Medicine.
Slovenian: Bolnice z mutacijami gena BRCA1/2 so identificirali bodisi s testiranjem germinalne linije v krvi z lokalnim testom bodisi s centralnim testom na Myriad ali s testiranjem vzorca tumorja s testom, izvedenim s strani Foundation Medicine.
English: Patient-reported outcome (PRO) data indicate no difference for the olaparib-treated patients as compared to placebo as assessed by the change from baseline in the TOI of the FACT-O.
Slovenian: Podatki o izidu po navedbi bolnic (PRO - patient-reported outcome) na podlagi spremembe indeksa TOI (Trial Outcome Index) lestvice FACT-O (Functional Analysis of Cancer Therapy - Ovarian) od izhodišča ne kažejo razlik med prejemnicami olapariba in prejemnicami placeba.
English: Median time (months) (95% CI)
Slovenian: Mediani čas (meseci) (95% IZ)
English: The recommended Lynparza dose reduction is to 100 mg taken twice daily (equivalent to a total daily dose of 200 mg) with a strong CYP3A inhibitor or 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Slovenian: Priporočeno zmanjšanje odmerka zdravila Lynparza je 100 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 200 mg) v primeru uporabe z močnim zaviralcem CYP3A ali 150 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg) v primeru uporabe z zmernim zaviralcem CYP3A (glejte poglavji 4.2 in 4.4).
English: A total of 18 (13.2%) patients received treatment for ≥5 years in the olaparib group compared with 1 (0.8%) patient in the placebo group.
Slovenian: V skupini z olaparibom je zdravljenje ≥ 5 let prejemalo skupaj 18 (13,2 %) bolnic, v skupini s placebom pa 1 (0,8 %) bolnica.
English: Multipack containing 112 (2 packs of 56) film-coated tablets.
Slovenian: Skupno pakiranje s 112 filmsko obloženimi tabletami (2 pakiranji po 56).
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).
Slovenian: Ob končni analizi (DCO 9. maj 2016) je bil čas od randomizacije do začetka prvega nadaljnjega zdravljenja ali smrti (TFST) med prejemnicami olapariba 9,4 meseca daljši (ROg 0,33; 95 % IZ: 0,22 do 0,49, p < 0,00001; mediana 15,6 meseca v primerjavi s 6,2 meseca).
English: Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib.
Slovenian: Lynparza 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg olapariba.
English: o A test is used to find out whether you have BRCA-mutated breast cancer.
Slovenian: o Za ugotavljanje tega, ali imate raka dojk z mutacijo BRCA, se uporablja poseben test.
English: In the placebo arm 49% of patients had received only 2 prior lines with 51% receiving 3 or more prior lines of treatment.
Slovenian: V skupini s placebom je 49 % bolnic prejemalo le 2 predhodni liniji zdravljenja, 51 % pa jih je predhodno prejemalo 3 linije zdravljenja ali več.
English: Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 1 month after receiving the last dose of Lynparza.
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Lynparza, med zdravljenjem in še 1 mesec po zadnjem odmerku zdravila Lynparza uporabljati dve obliki zanesljive kontracepcije.
English: If you feel dizzy, weak or tired while taking Lynparza, do not drive or use tools or machines.
Slovenian: Ne upravljajte vozil ali strojev, če ste med jemanjem zdravila omotični, šibki ali utrujeni.
English: Median time (months) (95% CI) HR (95% CI)
Slovenian: Mediani čas (meseci) (95 % IZ) ROg (95 % IZ)
English: Patients with HR+ (ER and/or PgR positive) tumours must have received and progressed on at least one endocrine therapy (adjuvant or metastatic) or had disease that the treating physician believed to be inappropriate for endocrine therapy.
Slovenian: Delež preživelih bolnic hormonskim zdravljenjem (adjuvantnim ali metastatskim), ali imeti bolezen, ki je bila po mnenju lečečega zdravnika neprimerna za hormonsko zdravljenje.
English: If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 100 mg (one 100 mg tablet) taken twice daily (equivalent to a total daily dose of 200 mg).
Slovenian: Če je treba sočasno uporabiti močen zaviralec CYP3A, je priporočeno zmanjšanje odmerka zdravila Lynparza na 100 mg (ena 100-mg tableta) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 200 mg).
English: The following adverse reactions have been identified in clinical trials with patients receiving Lynparza monotherapy where patient exposure is known.
Slovenian: Pri bolnicah, ki so v kliničnih preizkušanjih prejemale monoterapijo z zdravilom Lynparza (kjer je izpostavljenost bolnic znana), so zabeležili naslednje neželene učinke.
English: • colchicine - used to treat gout
Slovenian: • kolhicin - uporablja se za zdravljenje protina,
English: Figure 2 SOLO1: Kaplan-Meier plot of OS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (21% maturity)
Slovenian: SOLO1: Kaplan-Meierjeva krivulja celokupnega preživetja pri na novo diagnosticiranih bolnicah z napredovalim rakom jajčnikov in BRCA1/2m (21 % zrelost)
English: If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) (see sections 4.4 and 4.5).
Slovenian: Če je treba sočasno uporabiti zmeren zaviralec CYP3A, pa je priporočeno zmanjšanje odmerka zdravila Lynparza na 200 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg) (glejte poglavji 4.4 in 4.5).
English: Each film-coated tablet contains 150 mg of olaparib.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg olapariba.
English: PAES: In order to further confirm the efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the results of study D0816C00002, a phase III randomised double-blind placebo-controlled multicentre study.
Slovenian: Študija učinkovitosti po izdaji dovoljenje za promet (PAES): Za dodatno potrditev učinkovitosti olapariba pri bolnicah z recidivom na platino občutljivega slabo diferenciranega seroznega raka jajčnikov in mutacijo gena BRCA, mora imetnik dovoljenja za promet predložiti rezultate študije D0816C00002, randomizirane dvojno slepe, s placebom kontrolirane multicentrične študije III. faze.
English: • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Slovenian: • vzdrževalno zdravljenje odraslih bolnic, pri katerih je prišlo do ponovitve epitelijskega raka visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju, občutljivega na platino, ki so v popolnem ali delnem odzivu na kemoterapijo na osnovi platine.
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).
Slovenian: Študija je dosegla svoj primarni cilj in je dokazala statistično značilno izboljšanje preživetja brez napredovanja bolezni z olaparibom v primerjavi s placebom v celotni populaciji (ROg 0,35; 95 % IZ: 0,25 do 0,49, p < 0,00001, mediana 8,4 meseca z olaparibom in 4,8 meseca s placebom).
English: Lynparza 100 mg tablets olaparib
Slovenian: Lynparza 100 mg tablete olaparib
English: Yellow to dark yellow, oval, bi-convex tablet, debossed with ‘OP100' on one side and plain on the other side.
Slovenian: Rumena do temno rumena, ovalna, bikonveksna tableta z vtisnjeno oznako "OP100" na eni strani in brez oznak na drugi strani.
English: Lynparza 150 mg tablets olaparib
Slovenian: Lynparza 150 mg tablete olaparib
English: • You must not donate sperm while taking Lynparza and for 3 months after taking the last dose.
Slovenian: • Med jemanjem zdravila Lynparza in še 3 mesece po zadnjem odmerku ne smete darovati sperme.
English: If a further dose reduction is required, then reduction to 100 mg twice daily (equivalent to a total daily dose of 200 mg) is recommended.
Slovenian: Če je potrebno še dodatno zmanjšanje odmerka, je priporočljivo zmanjšanje na 100 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 200 mg).
English: In the HR+ patient subgroup the confirmed ORR was 57% (46/81) in the olaparib arm and 33% (11/33) in the comparator arm. bd Twice daily; CI Confidence interval; DOR Duration of response; DCO Data cut off; HR Hazard ratio; HR+ Hormone receptor positive, ORR Objective response rate; OS overall survival; PFS progression-free survival; PFS2 Time to second progression or death, TNBC triple negative breast cancer.
Slovenian: 2x/dan = dvakrat na dan, IZ = interval zaupanja, DCO = datum zamejitve podatkov, Rog = razmerje ogroženosti, HR+ = s pozitivnimi hormonskimi receptorji, ORR = delež objektivnega odziva, PFS = preživetje brez napredovanja bolezni, PFS2 = čas do drugega napredovanja bolezni ali do smrti, TNBC = trojno negativen rak dojk.
English: CYP3A4/5 are the isozymes predominantly responsible for the metabolic clearance of olaparib.
Slovenian: Za presnovni očistek olapariba so pretežno odgovorni izoencimi CYP3A4/5.
English: The incidence of dose interruptions, reductions and discontinuations due to an adverse event was 34.6%, 25.7% and 5.9%, respectively.
Slovenian: Večina bolnic je ostala na začetnem odmerku 400 mg olapariba dvakrat na dan. Pojavnost prekinitev uporabe je bila 34,6 %, zmanjšanj odmerka 25,7 % in prenehanj zaradi neželenega učinka 5,9 %.
English: The incidence of dose interruptions, reductions, discontinuations due to an adverse event was 45.1%, 25.1% and 10.8%, respectively.
Slovenian: Večina bolnic je ostala na začetnem odmerku 300 mg olapariba dvakrat na dan. Pojavnost prekinitev uporabe je bila 45,1 %, zmanjšanj odmerka 25,1 % in prenehanj zaradi neželenega učinka 10,8 %.
English: In the absence of functional BRCA1 or 2, DNA DSBs cannot be repaired via HRR.
Slovenian: Če funkcionalnih genov BRCA 1 ali 2 ni, homologno popravljanje z rekombinacijo ne more popraviti dvoverižnih prekinitev DNA.
English: Olaparib 400 mg bd Placebo
Slovenian: olaparib 400 mg dvakrat na dan placebo
English: If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg (one 150 mg tablet) taken twice daily (equivalent to a total daily dose of 300 mg) (see sections 4.4 and 4.5).
Slovenian: Če je treba sočasno uporabiti zmeren zaviralec CYP3A, pa je priporočeno zmanjšanje odmerka zdravila Lynparza na 150 mg (ena 150-mg tableta) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg) (glejte poglavji 4.4 in 4.5).
English: The safety and efficacy of olaparib as a maintenance therapy in the treatment of platinum-sensitive relapsed (PSR) high grade serous ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a Phase II randomised, double-blind, placebo-controlled trial (study 19).
Slovenian: Varnost in učinkovitost olapariba kot vzdrževalnega zdravljenja bolnic z recidivom na platino občutljivega (PSR - platinum-sensitive relapsed) slabo diferenciranega seroznega raka jajčnikov, vključno z jajcevodi ali primarno peritonealnega raka po zdravljenju z dvema ali več shemama na osnovi platine, so raziskali v randomiziranem, dvojno slepem, s placebom kontroliranem preskušanju II.
English: Silica, colloidal anhydrous Mannitol
Slovenian: Jedro tablete kopovidon koloidni brezvodni silicijev dioksid manitol natrijev stearilfumarat
English: Number of events: Total number of patients (%) 99:260 (38) Median time (months)
Slovenian: Število dogodkov: celotno število bolnic (%) Mediani čas (meseci)
English: Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets olaparib
Slovenian: Lynparza 100 mg filmsko obložene tablete Lynparza 150 mg filmsko obložene tablete olaparib
English: Lynparza dose adjustment is recommended for patients with moderate renal impairment (see section 4.2).
Slovenian: Pri bolnikih z zmerno okvaro ledvic se priporoča prilagoditev odmerka zdravila Lynparza (glejte poglavje 4.2).
English: Lynparza 50 mg hard capsules olaparib
Slovenian: Lynparza 50 mg trde kapsule olaparib
English: If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg).
Slovenian: Če je treba sočasno uporabiti močen zaviralec CYP3A, je priporočeno zmanjšanje odmerka zdravila Lynparza na 150 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg).
English: gBRCA1/2-mutated HER2-negative metastatic breast cancer OlympiAD (Study D0819C00003)
Slovenian: OlympiAD (študija D0819C00003)
English: Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150' on one side and plain on the other side.
Slovenian: Zelena do zeleno-siva, ovalna, bikonveksna tableta z vtisnjeno oznako "OP150" na eni strani in brez oznak na drugi strani.
English: • Each Lynparza 150 mg film-coated tablet contains 150 mg olaparib.
Slovenian: • Ena filmsko obložena tableta zdravila Lynparza 150 mg vsebuje 150 mg olapariba.
English: What Lynparza is used for
Slovenian: Za kaj uporabljamo zdravilo Lynparza
English: Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib.
Slovenian: Lynparza 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg olapariba.
English: Table 2 Summary of key efficacy findings for patients with BRCA-mutated PSR ovarian cancer in Study 19
Slovenian: Povzetek ključnih izsledkov o učinkovitosti pri PSR bolnicah z rakom jajčnikov in mutacijo gena BRCA v študiji 19
English: The safety and efficacy of olaparib as a maintenance therapy in the treatment of PSR ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a large Phase II randomised, double-blind, placebo-controlled trial (Study 19).
Slovenian: Varnost in učinkovitost olapariba kot vzdrževalnega zdravljenja bolnic, ki imajo na platino občutljive ponovitve (PSR) raka jajčnikov, vključno z jajcevodom ali primarnim peritonealnim rakom po zdravljenju z dvema ali več shemami s platino, so raziskali v obsežnem randomiziranem, dvojno slepem, s placebom kontroliranem preizkušanju II.
English: Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 1 month after receiving the last dose of Lynparza (see section 4.6).
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Lynparza, med zdravljenjem in še 1 mesec po zadnjem odmerku zdravila Lynparza uporabljati dve obliki zanesljive kontracepcije (glejte poglavje 4.6).
English: Table 4 Summary of key secondary objective outcomes for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Slovenian: Povzetek izidov ključnih sekundarnih ciljev pri PSR bolnicah z rakom jajčnikov in gBRCA1/2m v študiji SOLO2
English: Figure 1 SOLO1: Kaplan-Meier plot of PFS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (51% maturity - investigator assessment)
Slovenian: SOLO1: Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni pri na novo diagnosticiranih bolnicah z napredovalim rakom jajčnikov in BRCA1/2m (51 % zrelostraziskovalčeva ocena)
English: The recommended dose of Lynparza is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg.
Slovenian: Priporočeni odmerek zdravila Lynparza je 300 mg (dve 150-mg tableti) dvakrat na dan; to ustreza celotnemu dnevnemu odmerku 600 mg. 100-mg tablete so na voljo za zmanjšanje odmerka.
English: Figure 2 Study 19: Kaplan-Meier plot of OS in BRCA-mutated patients (73% maturity)
Slovenian: Slika 2 Študija 19: Kaplan Meierjevi krivulji celokupnega preživetja pri bolnicah z mutacijo gena BRCA (73 % zrelost)
English: A summary of the primary objective outcome for patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19 is presented in Table 4 and for all patients in Study 19 in Table 5 and Figure 4.
Slovenian: Povzetek izida primarnega cilja za vse bolnice in PSR bolnice z rakom jajčnikov in z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19 je prikazan v preglednici 5 ter za vse bolnice v študiji 19 v preglednici 5 in na sliki 4.
English: • Each Lynparza 100 mg film-coated tablet contains 100 mg olaparib.
Slovenian: • Ena filmsko obložena tableta zdravila Lynparza 100 mg vsebuje 100 mg olapariba.
English: In the olaparib and placebo arms, 17% and 20% of patients had prior bevacizumab, respectively.
Slovenian: Bevacizumab je predhodno prejemalo 17 % bolnic v skupini z olaparibom in 20 % bolnic v skupini s placebom.
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.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Olaparib je močan zaviralec humanih encimov poli(ADP-riboza)polimeraze (PARP-1, PARP-2 in PARP-3).
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).
Slovenian: V času analize PFS vmesni podatki o celokupnem preživetju niso bili dozoreli (21 %); ROg je bilo 0,95 (95 % IZ 0,60 do 1,53; vrednost p = 0,9).
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
Slovenian: Povzetek izidov ključnih sekundarnih ciljev za vse bolnice in za PSR bolnice z rakom jajčnikov z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19
English: Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Slovenian: Slika 1 Študija 19: Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni pri bolnicah z mutacijo gena BRCA (53 % zrelost - raziskovalčeva ocena)
English: No Lynparza dose adjustment is required for patients with mild or moderate hepatic impairment (see section 4.2).
Slovenian: Bolnikom z blago ali zmerno okvaro jeter odmerka zdravila Lynparza ni treba prilagoditi (glejte poglavje 4.2).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before or during treatment with Lynparza:
Slovenian: Pred začetkom zdravljenja z zdravilom Lynparza ali med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: DOR - DCO 09 December 2016
Slovenian: Trajanje odziva - DCO 09. december 2016
English: The most common histological type was serous (96%), endometrioid histology was reported in 2% of the patients.
Slovenian: Najpogostejša histološka vrsta je bila serozna (96 %),
English: Lynparza is used for the treatment of:
Slovenian: Za kaj uporabljamo zdravilo Lynparza Zdravilo Lynparza uporabljamo za zdravljenje:
English: How to store Lynparza
Slovenian: Shranjevanje zdravila Lynparza