FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients remained on the 400 mg bd starting dose of olaparib.
Croatian: Većina bolesnica nastavila je liječenje početnom dozom od 400 mg olapariba dvaput na dan.
English: Most patients were ECOG performance status 0 (81%), there are no data in patients with performance status 2 to 4.
Croatian: Većina bolesnica bila je s ECOG funkcionalnim statusom 0 (81%), dok nema podataka o bolesnicama s funkcionalnim statusom 2 - 4.
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.
Croatian: • terapiju održavanja kod odraslih bolesnica s recidivom na platinu osjetljivog epitelnog karcinoma jajnika visokog stupnja nediferenciranosti, karcinoma jajovoda ili primarnog peritonealnog karcinoma koje su ostvarile odgovor (potpun ili djelomičan) na kemoterapiju temeljenu na platini
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.
Croatian: Bolesnice s mutacijama BRCA1/2 gena identificirane su krvnim testom na germinativne mutacije pomoću lokalnog testa ili centralnim testiranjem u laboratoriju tvrtke Myriad ili testiranjem tumorskog uzorka pomoću koji je provodio kompanija Foundation Medicine.
English: In normal cells, homologous recombination repair (HRR), which requires functional BRCA1 and 2 genes, is effective at repairing these DNA DSBs.
Croatian: U normalnim se stanicama ti dvolančani lomovi DNK učinkovito popravljaju homolognom rekombinacijom (engl. homologous recombination repair, HRR), za koju su neophodni funkcionalni geni BRCA1 i 2. Ako ne postoji funkcionalni gen BRCA1 ili 2, dvolančani lomovi DNK ne mogu se popraviti homolognom rekombinacijom.
English: • you have certain side effects while you are taking Lynparza (see section 4).
Croatian: • ako se tijekom uzimanja lijeka Lynparza pojave određene nuspojave (pogledajte dio 4.).
English: Figure 3 SOLO2: Kaplan-Meier plot of PFS in patients with gBRCA1/2m PSR ovarian cancer (63% maturity - investigator assessment)
Croatian: SOLO2: Kaplan-Meierov dijagram za PFS kod bolesnica s recidivom na platinu osjetljivog karcinoma jajnika i mutacijom gBRCA1/2m (zrelost podataka: 63%ocjena ispitivača)
English: Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of olaparib-treated patients.
Croatian: Mučnina je dovela do privremenog prekida liječenja kod 14% bolesnica liječenih olaparibom, a do smanjenja doze kod njih 4%.
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.
Croatian: Kod bolesnica liječenih lijekom Lynparza prijavljena je hematološka toksičnost, uključujući kliničke dijagnoze i/ili laboratorijske nalaze koji upućuju na uglavnom blagu ili umjerenu (1. ili 2. stupnja prema Zajedničkim terminološkim kriterijima za nuspojave [engl.
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.
Croatian: Sažetak ključnih mjera ishoda sekundarnog cilja za bolesnica s recidivom na platinu osjetljivog karcinoma jajnika i mutacijom BRCA1/2 gena i sa BRCA1/2 wt/VUS u ispitivanju 19 prikazan je u Tablici 6 a za sve bolesnice u ispitivanju 19 u Tablici 6 i Slici 5.
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
Croatian: u sklopu (neo)adjuvantne terapije za metastatsku bolest u sklopu (neo)adjuvantne terapije i za metastatsku bolest
English: Lynparza 100 mg tablets olaparib
Croatian: Lynparza 100 mg tablete olaparib
English: In patients with mild renal impairment (creatinine clearance 51 to 80 ml/min), AUC increased by 24% and Cmax by 15% compared with patients with normal renal function.
Croatian: Kod bolesnika s blagim oštećenjem bubrežne funkcije (klirens kreatinina 51 do 80 ml/min), AUC se povećao za 24% i Cmax za 15% u usporedbi s bolesnicama s normalnom bubrežnom funkcijom.
English: Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016
Croatian: Ispitivanje 19: Kaplan-Meierov dijagram za OS u FAS-u (zrelost podataka: 79%); završni datum prikupljanja podataka: 9. svibnja 2016.
English: Lynparza 150 mg tablets olaparib
Croatian: Lynparza 150 mg tablete olaparib
English: How to store Lynparza
Croatian: Kako čuvati lijek Lynparza
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).
Croatian: Žene reproduktivne dobi moraju koristiti dvije pouzdane metode kontracepcije prije početka liječenja lijekom Lynparza, tijekom liječenja i još mjesec dana nakon primanja posljednje doze lijeka Lynparza (vidjeti dio 4.6).
English: Olaparib 400 mg capsule bd
Croatian: Olaparib 400 mg kapsule dvaput na dan
English: AUC by 170% (90% CI: 144-197%).
Croatian: (90% CI: 76 - 67%) i srednju vrijednost AUC za 87% (90% CI: 89 - 84%).
English: Each film-coated tablet contains 150 mg of olaparib.
Croatian: Jedna filmom obložena tableta sadrži 150 mg olapariba.
English: The majority of patients remained on the 300 mg bd starting dose of olaparib.
Croatian: Većina bolesnica nastavila je liječenje početnom dozom od 300 mg olapariba dvaput na dan.
English: OS - DCO 09 May 2016
Croatian: OS - završni datum prikupljanja podataka: 9. svibnja 2016.
English: The primary endpoint was PFS based on investigator assessment using RECIST 1.0.
Croatian: Primarna mjera ishoda bio je PFS prema ocjeni ispitivača na temelju verzije 1.0 RECIST kriterija.
English: Figure 1 SOLO1: Kaplan-Meier plot of PFS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (51% maturity - investigator assessment)
Croatian: Slika 1 SOLO1: Kaplan-Meierova krivulja PFS-a kod novodijagnosticiranih bolesnica s uznapredovalim karcinomom jajnika pozitivnim na BRCA1/2 mutacije (zrelost podataka: 51% - ocjena ispitivača)
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).
Croatian: Ako je neophodna istodobna primjena umjerenog inhibitora CYP3A, preporučuje se smanjenje doze lijeka Lynparza na 150 mg (jedna tableta od 150 mg) primijenjenih dvaput dnevno (odgovara ukupnoj dnevnoj dozi od 300 mg) (vidjeti dijelove 4.4 i 4.5).
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.
Croatian: Sažetak mjere ishoda primarnog cilja kod bolesnica s recidivom na platinu osjetljivog karcinoma jajnika i mutacijom gBRCA1/2 u ispitivanju SOLO2 prikazan je u Tablici 3 i na Slici 3.
English: Olaparib 300 mg bd
Croatian: Olaparib 300 mg 2x na dan
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).
Croatian: Ispitivanje je postiglo primarni cilj i pokazalo klinički važno i statistički značajno poboljšanje PFS-a prema ocjeni ispitivača kod primjene olapariba u odnosu na placebo, uz HR od 0,30 (95% CI: 0,22-0,41; p<0,0001; medijan: 19,1 mjesec uz olaparib naspram 5,5 mjeseci uz placebo).
English: * (2-sided)
Croatian: pvrijednost* (dvostrana)
English: Yellow to dark yellow, oval, bi-convex tablet, debossed with ‘OP100' on one side and plain on the other side.
Croatian: Žuta do tamnožuta, ovalna, bikonveksna tableta, s utisnutom oznakom „OP100” s jedne strane i bez oznaka s druge strane.
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).
Croatian: Ako je istodobna primjena snažnog inhibitora CYP3A nužna, preporučuje se smanjenje doze lijeka Lynparza na 100 mg (jedna tableta od 100 mg) primijenjenih dvaput dnevno (odgovara ukupnoj dnevnoj dozi od 200 mg).
English: Most patients were ECOG performance status 0 (77%), there are no data in patients with performance status 2 to 4.
Croatian: Većina je bolesnica imala ECOG funkcionalni status 0 (77%), dok nema podataka o bolesnicama s funkcionalnim statusom 2 - 4.
English: There is no requirement for BRCA1/2 testing prior to using Lynparza for the maintenance treatment of relapsed EOC, FTC or PPC who are in a complete or partial response to platinum-based therapy.
Croatian: Testiranje na mutacije gena BRCA1/2 nije obavezno prije primjene lijeka Lynparza za terapiju održavanja u slučaju recidiva epitelnog karcinoma jajnika visokog stupnja nediferenciranosti, karcinoma jajovoda ili primarnog peritonealnog karcinoma kod bolesnica koje su ostvarile potpun ili djelomičan odgovor na kemoterapiju utemeljenu na platini.
English: The primary endpoint was PFS determined by investigator assessment using RECIST 1.1.
Croatian: Primarna mjera ishoda bio je PFS prema ocjeni ispitivača na temelju verzije 1.1 RECIST kriterija.
English: Figure 2 Study 19: Kaplan-Meier plot of OS in BRCA-mutated patients (73% maturity)
Croatian: Slika 2 Ispitivanje 19: Kaplan-Meierov dijagram za OS kod bolesnica s mutacijom BRCA gena (zrelost podataka: 73%)
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.
Croatian: U ispitivanju se uspoređivala djelotvornost terapije održavanja lijekom Lynparza (300 mg [2 tablete od 150 mg] dvaput na dan), koja se primjenjivala do progresije bolesti, u odnosu na placebo kod 295 bolesnica s recidivom na platinu osjetljivog seroznog ili endometrioidnog karcinoma jajnika visokog stupnja nediferenciranosti (randomizacija u omjeru 2:1 - 196 za olaparib i
English: Table 2 Summary of key efficacy findings for patients with BRCA-mutated PSR ovarian cancer in Study 19
Croatian: Tablica 2 Sažetak ključnih rezultata za djelotvornost kod bolesnica s recidivom na platinu osjetljivog karcinoma jajnika s mutacijom BRCA gena iz Ispitivanja 19
English: Most patients were ECOG performance status 0 (78%), there are no data in patients with performance status 2 to 4.
Croatian: Većina je bolesnica imala ECOG funkcionalni status 0 (78%), dok nema podataka o bolesnicama s funkcionalnim statusom 2 - 4.
English: PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed (PSR) non-germline BRCA mutated high grade ovarian cancer in the maintenance setting and investigate predictive biomarkers within this patient group, the MAH should submit the results of study D0816C00020 (OPINION), a phase IIIb single-arm, open-label, multicentre study of maintenance therapy in PSR non-germline BRCA mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Croatian: PAES: Kako bi se dodatno definirala djelotvornost olpariba kod bolesnica s recidivom na platinu osjetljivog karcinoma jajnika visokog stupnja nediferenciranosti sa negerminativnom mutacijom BRCA gena, u uvjetima održavanja i istražilo prediktivne biomarkere unutar navedene skupine bolesnica, nositelj odobrenja treba predati rezultate otvorenog, multiceltričnog ispitivanja faze IIIb, s jednom skupinom, u kojem se ispituje terapija održavanja u bolesnica s recidivom na platinu osjetljivog karcinoma jajnika sa negerminativnom mutacijom BRCA gena koje su imale potpuni ili djelomičan odgovor na prethodu terapiju koja je bazirana na platini, D0816C00020 (OPINION).
English: Local or central testing of blood and/or tumour samples for BRCA1/2 mutations have been used in different studies.
Croatian: U različitim se ispitivanjima provodilo lokalno ili centralno testiranje uzoraka krvi i/ili tumora radi utvrđivanja mutacija gena BRCA1/2.
English: gBRCA1/2-mutated HER2-negative metastatic breast cancer OlympiAD (Study D0819C00003)
Croatian: OlympiAD (ispitivanje D0819C00003)
English: Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150' on one side and plain on the other side.
Croatian: Zelena do sivozelena, ovalna, bikonveksna tableta, s utisnutom oznakom „OP150” s jedne strane i bez oznaka s druge strane.
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).
Croatian: Ako je istodobna primjena snažnog inhibitora CYP3A nužna, preporučuje se smanjenje doze lijeka Lynparza na 150 mg primijenjenih dvaput dnevno (odgovara ukupnoj dnevnoj dozi od 300 mg).
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).
Croatian: Ispitivanje je postiglo primarni cilj i pokazalo statistički značajno poboljšanje PFS-a kod primjene olapariba u odnosu na placebo u ukupnoj populaciji, uz HR od 0,35 (95% CI: 0,25-0,49; p<0,00001; medijan: 8,4 mjeseca uz olaparib naspram 4,8 mjeseci uz placebo).
English: --------------Placebo bd - - - - - - - - - Olaparib 400 mg bd Number of patients at risk:
Croatian: --------------Placebo dvaput na dan - - - - - - - - - Olaparib 400 mg dvaput na dan Broj bolesnica pod rizikom:
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).
Croatian: U trenutku provođenja analize PFS-a interim podaci za OS bili su nezreli (21%), a omjer hazarda (engl. hazard ratio, HR) iznosio je 0,95 (95% CI 0,60; 1,53; p-vrijednost=0,9).
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.
Croatian: OS = ukupno preživljenje; CI = interval pouzdanosti; TFST = vrijeme od randomizacije do početka prve sljedeće terapije ili smrti.
English: Local or central testing of blood or tumour samples for BRCA1/2 mutations has been used in different studies.
Croatian: U različitim se ispitivanjima provodilo lokalno ili centralno testiranje uzoraka krvi ili tumora radi utvrđivanja mutacija gena BRCA1/2.
English: Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib.
Croatian: Lynparza 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg olapariba.
English: Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets olaparib
Croatian: Lynparza 100 mg filmom obložene tablete Lynparza 150 mg filmom obložene tablete olaparib
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).
Croatian: Sigurnost i djelotvornost olapariba kao terapije održavanja u liječenju recidiva na platinu osjetljivog karcinoma jajnika, jajovoda ili primarnog peritonealnog karcinoma nakon liječenja s dva ili više protokola baziranih na platini ispitivani su u velikom randomiziranom, dvostruko slijepom, placebom kontrolirana ispitivanju faze II (ispitivanje 19).
English: Olaparib 400 mg bd Placebo
Croatian: Olaparib 400 mg 2x na dan Placebo
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.
Croatian: T-limfocita; Kašalj uključuje sljedeće preporučene pojmove: kašalj i produktivni kašalj; Osip uključuje sljedeće preporučene pojmove: eksfolijacijski osip, generalizirani eritem, osip, eritemski osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip i pruritički osip; Preosjetljivost uključuje sljedeće preporučene pojmove: preosjetljivost na lijek i preosjetljivost; Dermatitis uključuje sljedeće preporučene pojmove: dermatitis, alergijski dermatitis i eksfolijacijski dermatitis; Dispneja uključuje sljedeće preporučene pojmove: dispneja i dispneja pri naporu; Stomatitis uključuje sljedeće preporučene pojmove: aftozni vrijed, ulceracije u ustima i stomatitis.
English: The safety and efficacy of olaparib as maintenance therapy were studied in patients with newly diagnosed advanced (FIGO Stage III-IV) high-grade serous or endometrioid BRCA1/2 mutated (BRCA1/2m) ovarian cancer following completion of first-line platinum-based chemotherapy in a Phase III randomised, double-blind, placebo-controlled, multicentre trial.
Croatian: Sigurnost i djelotvornost olapariba kao terapije održavanja ispitivale su se u randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju faze III kod bolesnica s novodijagnosticiranim uznapredovalim (stadij III - IV prema FIGO klasifikaciji) seroznim ili endometrioidnim karcinomom jajnika visokog stupnja nediferenciranosti pozitivnim na mutacije gena BRCA1/2, nakon završetka prve linije kemoterapije utemeljene na platini.
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).
Croatian: Sigurnost i djelotvornost olapariba kao terapije održavanja u liječenju recidiva na platinu osjetljivog seroznog karcinoma jajnika visokog stupnja nediferenciranosti, uključujući karcinom jajovoda ili primarni peritonealni karcinom, nakon liječenja s dva ili više protokola koja su uključivala platinu, ocijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze II
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
Croatian: Tablica 6 Sažetak ključnih mjera ishoda sekundarnog cilja za sve bolesnice i za bolesnice sa recidivom na platinu osjetljivog karcinoma jajnika i mutacijom BRCA1/2 gena i s BRCA1/2 wt/VUS u ispitivanju 19
English: OS
Croatian: o
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 hazard ratio (HR) of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib versus 4.8 months placebo).
Croatian: Ispitivanje je postiglo primarni cilj i pokazalo statistički značajno i klinički važno poboljšanje PFS-a uz olaparib u odnosu na placebo u ukupnoj populaciji, uz omjer rizika (HR) od 0,35 (95% CI 0,25-0,49; p<0,00001; medijan: 8,4 mjeseca uz olaparib naspram 4,8 mjeseci uz placebo).
English: gBRCA1/2-mutated HER2-negative metastatic breast cancer:
Croatian: Metastatski rak dojke pozitivan na gBRCA1/2 mutacije i negativan na HER2
English: NN:
Croatian: Muškarci:
English: Male patients must use a condom during therapy and for 3 months after receiving the last dose of Lynparza when having sexual intercourse with a pregnant woman or with a woman of childbearing potential.
Croatian: Bolesnici muškog spola moraju koristiti prezervativ kada stupaju u spolni odnos s trudnicom ili ženom reproduktivne dobi, i to tijekom liječenja i još 3 mjeseca nakon primanja posljednje doze lijeka Lynparza.
English: 51.3%; including 20 patients identified with a somatic tumour BRCA1/2 mutation) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
Croatian: Unaprijed planirana analiza podskupina pokazala je da su bolesnice oboljele od karcinoma jajnika s mutacijom BRCA1/2 gena (n=136; 51,3%; uključujući 20 bolesnica kod kojih je pronađena somatska tumorska mutacija BRCA1/2 gena) činile podskupinu koja je imala najveću kliničku korist od monoterapije održavanja olaparibom.
English: Pneumonitis, including events with a fatal outcome, has been reported in <1.0% of patients treated with Lynparza in clinical studies.
Croatian: Kod < 1,0% bolesnica koje su u kliničkim ispitivanjima primale lijek Lynparza prijavljen je pneumonitis uključujući i događaje sa smrtnim ishodom.
English: Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib.
Croatian: Lynparza 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg olapariba.
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.
Croatian: Pri uključivanju u ispitivanje kod 73% bolesnica u skupini liječenoj olaparibom i 77% bolesnica u skupini koja je primala placebo nije bilo znakova bolesti (potpun odgovor), što je prema definiciji ispitivača značilo izostanak radioloških dokaza bolesti te vrijednost tumorskog antigena 125 (engl. cancer antigen 125, CA-125) unutar normalnog raspona.
English: Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Croatian: Slika 1 Ispitivanje 19: Kaplan-Meierov dijagram za PFS kod bolesnica s mutacijom BRCA gena (prema ocjeni ispitivača, uz zrelost podataka od 52%)
English: Table 5 Summary of primary objective outcome for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Croatian: Tablica 5 Sažetak mjere ishoda primarnog cilja kod svih bolesnica i bolesnica s recidivom na platinu osjetljivog karcinoma jajnika i mutacijom BRCA1/2 gena i s BRCA1/2 wt/VUS u ispitivanju 19
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.
Croatian: Sažetak mjere ishoda primarnog cilja kod bolesnica s recidivom na platinu osjetljivog karcinoma jajnika i mutacijom BRCA1/2 gena i sa BRCA1/2 wt/VUS u ispitivanju 19 prikazan je u Tablici 4, a za sve bolesnice iz ispitivanja 19 u Tablici 5 te na Slici 4.
English: • decrease in the number of platelets in blood (thrombocytopenia) - you may notice the following symptoms:
Croatian: • smanjen broj krvnih pločica u krvi (trombocitopenija) - možda ćete primijetiti sljedeće simptome: o modrice ili krvarenje koje traje dulje nego inače ako se ozlijedite
English: Very common Anaemia Common Neutropenia a, Thrombocytopenia a,
Croatian: Poremećaji krvi i limfnog sustava vrlo često anemija a, neutropenija a, trombocitopenija a,
English: Figure 2 SOLO1: Kaplan-Meier plot of OS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (21% maturity)
Croatian: Slika 2 SOLO1: Kaplan-Meierova krivulja OS-a kod novodijagnosticiranih bolesnica s uznapredovalim karcinomom jajnika pozitivnim na BRCA1/2 mutacije (zrelost podataka: 21%)