FrancophonIA/ELRC3.0 huggingface dataset:
English: In normal cells, homologous recombination repair (HRR) pathway 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).
English: Patients whose disease had recurred >6 months after completion of penultimate platinum-based chemotherapy were enrolled.
Croatian: Bolesnice kod kojih je recidiv bolesti nastupio > 6 mjeseci nakon završetka pretposljednje kemoterapije utemeljene na platini uključene su u ispitivanje.
English: In vitro, olaparib has been shown to be an inhibitor of BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K.
Croatian: In vitro olaparib se pokazao inhibitorom za BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 i MATE2K.
English: In vitro, data also show that olaparib is not a substrate for OATP1B1, OATP1B3, OCT1, BCRP or MRP2 and is not an inhibitor of OATP1B3, OAT1 or MRP2.
Croatian: In vitro podaci pokazuju i da olaparib nije supstrat za OATP1B1, OATP1B3, OCT1, BCRP ili MRP2, i da nije inhibitor OATP1B3, OAT1 ili MRP2.
English: Contraception in males
Croatian: Kontracepcija kod muškaraca
English: Ovarian cancer Lynparza is indicated as monotherapy for the:
Croatian: Lynparza je indicirana kao monoterapija za:
English: Lynparza 50 mg hard capsules
Croatian: Lynparza 50 mg tvrde kapsule
English: The most frequent adverse reactions leading to dose interruption or dose reduction were nausea, anaemia, vomiting, neutropenia and fatigue.
Croatian: Najčešće nuspojave koje su dovela do privremenog prekida lječenja ili do smanjenja doziranja su mučnina, anemija, povraćanje, neutropenija i umor.
English: Maintenance treatment of platinum sensitive relapsed ovarian cancer:
Croatian: Terapija održavanja kod recidiva karcinoma jajnika osjetljivog na platinu:
English: Paediatric population No studies have been conducted in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja kod pedijatrijskih bolesnika.
English: Before Lynparza treatment is initiated for first-line maintenance treatment of high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC), patients must have confirmation of deleterious or suspected deleterious germline and/or somatic mutations in the breast cancer susceptibility genes (BRCA) 1 or 2 using a validated test.
Croatian: Prije uvođenja lijeka Lynparza za prvu liniju terapije održavanja kod epitelnog karcinoma jajnika visokog stupnja nediferenciranosti, karcinoma jajovoda ili primarnog peritonealnog karcinoma, bolesnice moraju imati potvrđene štetne ili suspektne štetne germinativne i/ili somatske mutacije gena koji određuju podložnost raku dojke (BRCA) 1 ili 2, utvrđene validiranim testom.
English: Film-coated tablets 56 film-coated tablets
Croatian: Filmom obložene tablete 56 filmom obloženih tableta
English: First-line maintenance treatment of BRCA-mutated advanced ovarian cancer: SOLO1 Study
Croatian: Prva linija terapije održavanja za uznapredovali karcinom jajnika pozitivan na mutacije BRCA gena: ispitivanje SOLO1
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.
Croatian: U skupini liječenoj olaparibom, 23,5% (n=32/136) bolesnica nastavilo je liječenje tijekom ≥2 godine u usporedbi sa 3,9% (n=5/128) bolesnica koje su primale placebo.
English: Therefore, caution should be taken if these medicinal products are co-administered with Lynparza and patients should be closely monitored.
Croatian: Stoga je pri istodobnoj primjeni tih lijekova s lijekom Lynparza potreban oprez i pažljiv nadzor bolesnika.
English: bd Twice daily; NR Not reached; CI Confidence interval; PFS Progression-free survival; PFS2 Time to second progression or death; OS Overall survival; TFST Time from randomisation to first subsequent anti-cancer therapy or death.
Croatian: ND=nije dosegnuto; CI=interval pouzdanosti; PFS=preživljenje bez progresije bolesti; PFS2=vrijeme do druge progresije ili smrti; OS=ukupno preživljenje; TFST=vrijeme od randomizacije do prve sljedeće terapije za rak ili smrti.
English: Seven male patients were randomised (5 olaparib and 2 comparator).
Croatian: U sklopu ispitivanja randomizirano je sedam bolesnika muškog spola (5 u skupinu koja je primala olaparib i 2 u skupinu koja je primala usporednu terapiju).
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”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti od 100 mg ili 150 mg, tj. zanemarive količine natrija.
English: Appropriate clinical monitoring is recommended for patients receiving this type of medicinal product concomitantly.
Croatian: U bolesnika koji istodobno primaju ovakvu vrstu lijekova preporučuje se odgovarajuće kliničko praćenje.
English: • Capsule content: lauroyl macrogol-32 glycerides.
Croatian: • Sadržaj kapsule: makrogol[32]glicerollaurat
English: Lynparza is available as 100 mg and 150 mg tablets.
Croatian: Lynparza je dostupna u obliku tableta od 100 mg i 150 mg.
English: • Capsule shell: hypromellose, titanium dioxide (E171), gellan gum (E418), potassium acetate.
Croatian: • Ovojnica kapsule: hipromeloza, titanijev dioksid (E171), gelan guma (E418), kalijev acetat
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.
Croatian: U podskupini bolesnika s trostruko negativnim rakom dojke potvrđeni ORR iznosio je 48% (41/86) u skupini koja je primala olaparib te 12% (4/33) u usporednoj skupini.
English: Platinum free interval was > 12 months in 60% and 6-12 months in 40% of the patients.
Croatian: Interval bez platine bio je >12 mjeseci u 60% i 6-12 mjeseci u 40% bolesnica.
English: • Printing ink: shellac, iron oxide black (E172).
Croatian: • Tinta za označavanje: šelak, crni željezov oksid (E172)
English: Missing dose If a patient misses a dose of Lynparza, they should take their next normal dose at its scheduled time.
Croatian: Ako bolesnik propusti dozu lijeka Lynparza, sljedeću uobičajenu dozu treba uzeti prema predviđenom rasporedu.
English: Although patient numbers were limited, 13.2% (n=18/136) of the patients in the olaparib-treated group remained on treatment for ≥5 years as compared with 0.8% (n=1/128) in the placebo group.
Croatian: Iako je broj bolesnica ograničen, 13,2% (n=18/136) bolesnica u skupini liječenoj olaparibom nastavilo je liječenje tijekom ≥5 godina u usporedbi sa 0,8% (n=1/128) bolesnica koje su primale placebo.
English: Nausea events led to discontinuation in 2.3% of olaparib-treated patients (CTCAE Grade 2) and 0.8% of placebo-treated patients (CTCAE Grade 1); 0.8% and 0.4% of olaparib-treated patients discontinued treatment due to low grade (CTCAE Grade 2) vomiting and dyspepsia, respectively.
Croatian: Mučnina je dovela do prekida liječenja kod 2,3% bolesnica liječenih olaparibom (2. stupanj prema CTCAE kriterijima) te 0,8% bolesnica koje su primale placebo (1. stupanj prema CTCAE kriterijima); liječenje je zbog povraćanja odnosno dispepsije niskog stupnja težine (2. stupnja prema CTCAE kriterijima) prekinulo 0,8% odnosno 0,4% bolesnica liječenih olaparibom.
English: Previous taxane treatment in (neo)adjuvant setting metastatic setting
Croatian: Prethodno liječenje taksanom (%) u sklopu (neo)adjuvantne terapije za metastatsku bolest
English: There are limited clinical data available in non-Caucasian patients.
Croatian: Ograničeni su klinički podaci o primjeni kod bolesnika koji nisu bijele rase.
English: Distribution The in vitro plasma protein binding is approximately 82% at 10 µg/mL which is approximately Cmax.
Croatian: In vitro vezivanje za proteine u plazmi pri koncentraciji od 10 μg/ml, koja približno odgovara Cmax, iznosi približno 82%.
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.
Croatian: Patient-reported outcome, PRO) pokazuju da nema razlike između bolesnica liječenih olaparibom u usporedbi sa placebom, što je ocjenjivano promjenom početne vrijednosti indeksa za ocjenu ishoda ispitivanja (engl.
English: Patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
Croatian: Bolesnice 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 trebaju započeti liječenje lijekom Lynparza najkasnije 8 tjedana nakon završetka posljednje doze u sklopu protokola koji sadrži platinu.
English: Patients who have received two or more platinum-containing regimens and whose disease had recurred >6 months after completion of penultimate platinum-based chemotherapy were enrolled.
Croatian: Bolesnice koje su primile dva ili više protokola utemeljenih na platini, te kod kojih je recidiv bolesti nastupio > 6 mjeseci nakon završetka pretposljednje kemoterapije utemeljene na platini uključene su u ispitivanje.
English: Please note Lynparza is also available as a 100 mg and 150 mg tablet.
Croatian: Imajte na umu da je Lynparza dostupna i u obliku tablete od 100 mg i 150 mg.
English: Figure 4 Study 19: Kaplan-Meier plot of PFS in the FAS (58% maturity - investigator assessment) DCO 30 June 2010
Croatian: Ispitivanje 19: Kaplan-Meierov dijagram za PFS u FAS-u (zrelost podataka: 58%ocjena ispitivača); završni datum prikupljanja podataka: 30. lipnja 2010.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide black (E172) (150 mg tablets only)
Croatian: Ovojnica tablete hipromeloza makrogol 400 titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crni (E172) (samo tablete od 150 mg)
English: If MDS and/or AML are confirmed while on treatment with Lynparza, it is recommended that Lynparza should be discontinued and the patient be treated appropriately.
Croatian: Ako se tijekom liječenja lijekom Lynparza potvrdi dijagnoza MDS-a i/ili AML-a, preporučuje se prekinuti primjenu lijeka Lynparza i primjereno liječiti bolesnika.
English: TFST - DCO 09 May 2016
Croatian: TFST - završni datum prikupljanja podataka: 9. svibnja 2016.
English: Lynparza co-administration with strong or moderate CYP3A inducers is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Lynparza sa snažnim ili umjerenim induktorima CYP3A.
English: Very common Fatigue (including asthenia)
Croatian: često umor (uključujući asteniju)
English: Capsule content Lauroyl macrogol-32 glycerides
Croatian: Sadržaj kapsule makrogol[32]glicerollaurat
English: • a certain type of breast cancer (BRCA-mutated, HER2-negative) which has spread beyond the original tumour.
Croatian: • određene vrste raka dojke (koji je pozitivan na mutacije gena BRCA i negativan na receptor humanog epidermalnog faktora rasta 2 [HER2]) koji se proširio izvan područja prvotnog tumora.
English: Combination with anastrozole, letrozole and tamoxifen A clinical study has been performed to assess the combination of olaparib with anastrozole, letrozole or tamoxifen.
Croatian: Provedeno je kliničko ispitivanje kako bi se ocijenila kombinacija olapariba s anastrozolom, letrozolom ili tamoksifenom.
English: Subgroup analysis indicated PFS benefit of olaparib versus comparator in TNBC (HR 0.43; 95% CI: 0.29-0.63, n=152) and HR+ (HR 0.82; 95% CI: 0.55-1.26, n=150) patient subgroups.
Croatian: Analiza podskupina pokazala je da je olaparib ostvario korisne učinke na PFS u odnosu na usporednu terapiju u podskupini s trostruko negativnim rakom dojke (HR: 0,43; 95% CI: 0,29 - 0,63; n=152) te u podskupini bolesnika s HR+ rakom dojke (HR: 0,82; 95% CI: 0,55 - 1,26; n=150).
English: The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) twice daily (equivalent to a total daily dose of 500 mg).
Croatian: Preporučuje se smanjiti dozu na 250 mg (jedna tableta od 150 mg i jedna tableta od 100 mg) dvaput na dan (što odgovara ukupnoj dnevnoj dozi od 500 mg).
English: Placebo Olaparib 400 mg capsule bd
Croatian: Placebo Olaparib 400 mg kapsule dvaput na dan
English: No olaparib or placebo-treated patients discontinued due to diarrhoea.
Croatian: Nijedna bolesnica koja je primala olaparib ili placebo nije prekinula liječenje zbog proljeva.
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).
Croatian: Medijan produljenja PFS-a kod bolesnica liječenih olaparibom iznosio je 6,9 mjeseci u odnosu na placebo (HR 0,18; 95% CI 0,10-0,31; p<0,00001; medijan od 11,2 mjeseca naspram 4,3 mjeseca).
English: In population based PK analyses, patient age, bodyweight or race (including White and Japanese patients) were not significant covariates.
Croatian: Dob, tjelesna težina i rasa bolesnice (uključujući bijelu rasu i japansko podrijetlo) nisu bile značajne kovarijante u populacijskim farmakokinetičkim analizama.
English: The key efficacy findings from Study 19 for BRCA-mutated patients are presented in Table 2, and Figures 1 and 2.
Croatian: Ključni rezultati za djelotvornost iz Ispitivanja 19 kod bolesnica s mutacijom BRCA gena prikazani su u Tablici 2 te na Slikama 1 i 2.
English: The majority of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers.
Croatian: U većini prijavljenih slučajeva radilo se o nositeljima germinativne mutacije gena 1 ili 2 koja osobe čini podložnima karcinomu dojke (gBRCA1/2).
English: Median time (months) (95% CI) HR (95% CI)
Croatian: Medijan vremena (mjeseci) (95% CI) HR (95% CI)
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.
Croatian: U ispitivanju se uspoređivala djelotvornost Lynparza kapsula kao terapije održavanja (400 mg [8 kapsula od 50 mg] dvaput na dan), koja se uzimala do progresije bolesti, u odnosu na placebo kod 265 bolesnica s recidivom na platinu osjetljivog seroznog karcinoma jajnika visokog stupnja nediferenciranosti (136 bolesnica primalo je olaparib, a 129 placebo) koje su ostvarile odgovor (CR ili PR) nakon završetka kemoterapije koja je sadržavala platinu.
English: OS (64% maturity) - DCO 25 September 2017
Croatian: OS (zrelost podataka: 64%) - završni datum prikupljanja podataka: 25. rujna 2017.
English: Distribution The in vitro protein binding is approximately 82% at clinically relevant concentrations of 10 µg/mL.
Croatian: Distribucija In vitro vezivanje za proteine pri klinički relevantnim koncentracijama od 10 μg/ml iznosi približno
English: Within the BRCA-mutated population the disease control rate at 24 weeks was 57% and 24% for patients in the olaparib and placebo groups, respectively.
Croatian: Unutar populacije bolesnica s mutacijom BRCA gena, stopa kontrole bolesti u 24. tjednu iznosila je 57% u skupini liječenoj olaparibom i 24% u onoj koja je primala placebo.
English: Lynparza 150 mg tablets are green to green/grey, oval, bi-convex, film-coated tablets, marked with “OP150” on one side and plain on the other.
Croatian: Lynparza 150 mg tablete su zelene do sivozelene, ovalne, bikonveksne filmom obložene tablete, s oznakom ‘OP150' s jedne strane i bez oznaka s druge strane.
English: Anaemia was the most common CTCAE grade ≥3 adverse reaction reported in clinical studies.
Croatian: Najčešća nuspojava ≥ 3. stupnja prema CTCAE kriterijima prijavljena u kliničkim ispitivanjima bila je anemija.
English: Lynparza 50 mg hard capsules olaparib
Croatian: Lynparza 50 mg tvrde kapsule olaparib
English: Proportion of patients alive progression during platinum treatment and in the (neo)adjuvant setting provided the last dose was received at least 12 months prior to randomisation.
Croatian: Prethodno liječenje platinom u sklopu terapije za metastatsku bolest bilo je dopušteno pod uvjetom da nije bilo dokaza progresije bolesti tijekom (neo)adjuvantne terapije platinom i pod uvjetom da je bolesnik posljednju dozu primio najmanje 12 mjeseci prije randomizacije.
English: Patients with CR defined by the investigator had HR 0.34 (95% CI 0.24-0.47); median PFS not reached on olaparib vs 15.3 months on placebo.
Croatian: Kod bolesnica koje su prema definiciji ispitivača imale potpun odgovor HR je iznosio 0,34 (95% CI 0,24 - 0,47; medijan PFS-a u skupini koja je primala olaparib nije dosegnut, dok je uz placebo iznosio 15,3 mjeseca).
English: Nausea was generally reported very early, with first onset within the first month of Lynparza treatment in the majority of patients.
Croatian: Mučnina je obično prijavljena vrlo rano te je kod većine bolesnika prvi put nastupila u prvom mjesecu liječenja lijekom Lynparza.
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.
Croatian: Anemija uključuje sljedeće preporučene pojmove: anemija, makrocitna anemija, eritropenija, snižena razina hematokrita, snižena razina hemoglobina, normokromna anemija, normokromno-normocitna anemija, normocitna anemija i smanjen broj crvenih krvnih stanica; Neutropenija uključuje sljedeće preporučene pojmove: agranulocitoza, febrilna neutropenija, smanjen broj granulocita, granulocitopenija, idiopatska neutropenija, neutropenija, neutropenijska infekcija, neutropenijska sepsa i smanjen broj neutrofila; Trombocitopenija uključuje sljedeće preporučene pojmove: smanjen broj trombocita, smanjeno stvaranje trombocita, snižena razina trombocitokrita i trombocitopenija; Leukopenija uključuje sljedeće preporučene pojmove: leukopenija i smanjen broj bijelih krvnih stanica; Limfopenija uključuje sljedeće preporučene pojmove: smanjen broj B-limfocita, smanjen broj limfocita, limfopenija i smanjen broj 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: Table 2 Efficacy results for newly diagnosed patients with BRCA1/2m advanced ovarian cancer in SOLO1
Croatian: Tablica 2 Rezultati za djelotvornost kod novodijagnosticiranih bolesnica s uznapredovalim karcinomom jajnika pozitivnim na BRCA1/2 mutacije u ispitivanju SOLO1
English: The incidence of dose interruptions, reductions, discontinuations due to an adverse event was 45.1%, 25.1% and 10.8%, respectively.
Croatian: Incidencija privremenog prekida doziranja bila je 45,1%, smanjenja doziranja 25,1% i prekida doziranja zbog pojava nuspojava 10,8%.
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.
Croatian: Preporučena doza lijeka Lynparza je 300 mg (dvije tablete od 150 mg) dvaput na dan, što odgovara ukupnoj dnevnoj dozi od 600 mg.
English: Platinum free interval was > 12 months in 60% and >6-12 months in 40% of the patients.
Croatian: Interval bez platine bio je >12 mjeseci u 60% i >6-12 mjeseci u 40% bolesnica
English: The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo).
Croatian: Ispitivačevu ocjenu PFS-a poduprla je zaslijepljena neovisna centralizirana radiološka procjena PFS-a (HR: 0,25; 95% CI: 0,18-0,35; p<0,0001; medijan: 30,2 mjeseca uz olaparib naspram 5,5 mjeseci uz placebo).
English: Maintenance treatment of platinum-sensitive relapsed (PSR) ovarian cancer SOLO2 Study
Croatian: Terapija održavanja kod recidiva karcinoma jajnika osjetljivog na platinu Ispitivanje SOLO2
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 decrease and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased;
Croatian: Anemija uključuje sljedeće preporučene pojmove: anemija, makrocitna anemija, eritropenija, snižena razina hematokrita, snižena razina hemoglobina, normokromna anemija, normokromno-normocitna anemija, normocitna anemija i smanjen broj crvenih krvnih stanica; Neutropenija uključuje sljedeće preporučene pojmove: agranulocitoza, febrilna neutropenija, smanjen broj granulocita, granulocitopenija, idiopatska neutropenija, neutropenija, neutropenijska infekcija, neutropenijska sepsa i smanjen broj neutrofila; Trombocitopenija uključuje sljedeće preporučene pojmove: smanjen broj trombocita, smanjeno stvaranje trombocita, snižena razina trombocitokrita i trombocitopenija; Leukopenija uključuje sljedeće preporučene pojmove: leukopenija i smanjen broj bijelih krvnih stanica; Limfopenija uključuje sljedeće preporučene pojmove: smanjen broj B-limfocita, smanjen broj limfocita,limfopenija i smanjen broj
English: For the secondary endpoint of OS, the HR for olaparib versus placebo was 0.62 (95% CI 0.42-0.93; p=0.02140; median 34.9 months versus 30.2 months) (Table 2).
Croatian: Omjer hazarda za olaparib u odnosu na placebo za sekundarnu mjeru ishoda (OS) iznosio je 0,62 (95% CI 0,42-0,93; p=0,02140; medijan od 34,9 mjeseci naspram 30,2 mjeseca) (Tablica 2).
English: • indigestion or heartburn (dyspepsia)
Croatian: • probavne smetnje ili žgaravica (dispepsija)
English: In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (elevations) from baseline in blood creatinine was approximately 10%.
Croatian: U kliničkim ispitivanjima lijeka Lynparza incidencija promjene (povećanja) početne vrijednosti kreatinina u krvi prema CTCAE kriterijima ≥ 2 stupnja iznosila približno 10%.