natgillin/translations-raw huggingface dataset:
Treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies The efficacy of rucaparib was investigated in 106 patients in 2 multicentre, single-arm, open-label clinical studies, Study 10 and ARIEL2, in patients with advanced BRCA-mutant epithelial ovarian, fallopian tube or primary peritoneal cancer who had progressed after 2 or more prior chemotherapies (the primary efficacy population).
Liječenje raka jajnika s BRCA mutacijama nakon 2 ili više kemoterapija Djelotvornost rukapariba ispitana je na 106 bolesnica u 2 multicentrična, otvorena klinička ispitivanja na jednoj skupini, Ispitivanje 10 i ARIEL2, na bolesnicama s uznapredovalim epitelnim rakom jajnika, jajovoda ili primarnim peritonealnim rakom s BRCA mutacijama koje su imale progresiju nakon 2 ili više prethodnih kemoterapija (populacija za ocjenu primarnog ishoda djelotvornosti).
Rucaparib showed no effect on Cmax of caffeine while moderately increasing AUCinf of caffeine by 2.55 fold (90% CI: 2.12, 3.08).
Rukaparib nije pokazao učinak na Cmax kofeina dok je umjereno povećao AUCinf kofeina za 2,55 puta (90% CI: 2,12; 3,08).
If you stop taking Rubraca
Ako prestanete uzimate lijek Rubraca
In vitro, rucaparib is an inhibitor of the BCRP and P-gp efflux transporters.
In vitro, rukaparib inhibira BCRP i P-gp efluks transportere.
In a medicinal product interaction study in cancer patients, the effects of steady-state rucaparib at 600 mg twice daily on CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp were evaluated with single oral doses of sensitive probes (caffeine, S-warfarin, omeprazole, midazolam, and digoxin, respectively).
U ispitivanju interakcije lijekova u bolesnica oboljelih od raka, pri dozi od 600 mg dva puta dnevno, u stanju dinamičke ravnoteže, procijenjeni su učinci rukapariba na CYP1A2, CYP2C9, CYP2C19, CYP3A i P-glikoprotein (P-gp) uz jednu peroralnu dozu osjetljivih proba (kofein, S-varfarin, omeprazol, midazolam i digoksin).
Rucaparib down regulated CYP2B6 in human hepatocytes at clinically relevant exposures.
Rukaparib je doveo do regulacije na niže (engl. down regulation) CYP2B6 u ljudskim hepatocitima pri klinički relevantnim izloženostima.
Leukopeniab, Lymphopeniab, Febrile neutropenia
Često leukopenijab, limfopenijab, febrilna neutropenija
Inhibition of MRP4 by rucaparib cannot be fully ruled out at clinical exposures.
Inhibicija MRP4 rukaparibom pri kliničkoj izložnosti ne može se u potpunosti isključiti.
When co-administering medicinal products that are CYP2C9 substrates with a narrow therapeutic index (e.g., warfarin, phenytoin), dose adjustments may be considered, if clinically indicated.
Kad se istodobno primjenjuju lijekovi koji su supstrati CYP2C9 s uskim terapijskim indeksom (npr. varfarin, fenitoin), mogu se razmotriti prilagodbe doze ako je klinički indicirano.
In patients with cancer following rucaparib 600 mg taken twice daily, the mean steady-state Cmax was 1940 ng/mL and AUC0-12h was 16900 h⋅ng/mL with Tmax of 1.9 hours.
U bolesnica s rakom nakon doziranja rukapariba 600 mg dva puta dnevno, srednja vrijednost Cmax u stanju dinamičke ravnoteže bila je 1940 ng/ml, a vrijednost AUC0-12h bila je 16900 h⋅ng/ml s Tmax od 1,9 sati.
Median overall survival - months (95% CI)
Medijan ukupnog preživljenja - mjeseci (95 %
Patients with mild renal impairment (N=149; CLcr between 60 and 89 mL/min, as estimated by the Cockcroft-Gault method) and those with moderate renal impairment (N=76; CLcr between 30 and 59 mL/min) showed approximately 15% and 33% higher steady-state AUC, respectively, compared to patients with normal renal function (N=147; CLcr greater than or equal to 90 mL/min).
Bolesnice s blagim oštećenjem funkcije bubrega (N=149; CLcr između 60 i 89 ml/min, procijenjeno Cockcroft-Gaultovom metodom) i one s umjerenim oštećenjem funkcije bubrega (N=76; CLcr između 30 i 59 ml/min) pokazale su otprilike 15 % odnosno 33 % veći AUC u stanju dinamičke ravnoteže, u usporedbi s bolesnicama s normalnom funkcijom bubrega (N=147; CLcr veći od ili jednak 90 ml/min).
Third dose reduction
Treće smanjenje doze
In order to further confirm the safety and efficacy of rucaparib in the treatment of platinum sensitive, relapsed or progressive, BRCA mutated (germline and/ or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, the MAH should submit the results of study CO-338-043 (ARIEL4), a phase 3, multicentre, open-label, randomised study evaluating the efficacy and safety of rucaparib versus chemotherapy for treatment of relapsed ovarian cancer.
Kako bi se dodatno potvrdila sigurnost i djelotvornost rukapariba u liječenju relapsnog ili progresivnog, na platinu osjetlivog, epitelnog raka jajnika, jajovoda ili primarnog peritonealnog raka, visokog gradusa, s BRCA mutacijama (germinativnim i/ili somatskim), nositelj odobrenja za stavljanje lijeka u promet treba dostaviti rezultate ispitivanja CO-338-043 (ARIEL4), multicentričnog, otvorenog, randomiziranog ispitivanja faze 3 za procjenu djelotvornosti i sigurnosti rukapariba u usporedbi s kemoterapijom za liječenje relapsnog raka jajnika.
In addition, according to its mechanism of action rucaparib may have the potential to impair fertility in humans.
Nadalje, na temelju mehanizma djelovanja, rukaparib može imati potencijal za uzrokovanje poremećaja plodnosti kod žena.
Rucaparib induced CYP1A2, and down regulated CYP2B6 and CYP3A4 in human hepatocytes at clinically relevant exposures.
Rukaparib je inducirao CYP1A2 i regulirao na niže CYP2B6 i CYP3A4 u ljudskim hepatocitima pri klinički relevantnim izloženostima.
• redness, swelling, and pain on the palms of the hands and, or the soles of the feet
• crvenilo, oticanje i bol u dlanovima i tabanima • crvene mrlje na koži
Very common (may affect more than 1 in 10 people):
Vrlo često (može se javiti u više od 1 u 10 osoba):
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Missed doses If a dose is missed, the patient should resume taking Rubraca with the next scheduled dose.
Ako je doza propuštena, bolesnica treba nastaviti uzimati lijek Rubraca u uobičajeno vrijeme predviđeno za sljedeću dozu.
Talk to your doctor, pharmacist or nurse before or during taking Rubraca.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Rubraca.
A pregnancy test before initiating treatment is recommended in women of reproductive potential.
Ženama u reproduktivnoj dobi preporučuje se napraviti test na trudnoću prije početka liječenja.
Rucaparib showed no effect on Cmax of digoxin while marginally increasing AUC0-72h by 1.20 fold (90% CI: 1.12 to 1.29).
Rukaparib nije pokazao učinak na Cmax digoksina dok je marginalno povećao AUC0-72h za 1,20 puta (90 % CI: 1,12; 1,29).
Adverse reactions that most commonly led to dose reduction or interruption were anaemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%).
Nuspojave koje su najčešće dovele do smanjenja doze ili prekida bile su anemija (20 %), umor/astenija (18 %), mučnina (16 %), trombocitopenija (15 %) i povišene vrijednosti AST-a/ALT-a (10 %).
Rucaparib induced structural chromosomal aberrations in the in vitro human lymphocyte chromosomal aberration assay.
Rukaparib je inducirao strukturalne kromosomske aberacije u in vitro testu kromosomskih aberacija na ljudskim limfocitima.
The ≥ Grade 3 adverse reactions occurring in > 5% of patients were anaemia (23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%), thrombocytopenia (6%), and nausea (5%).
Nuspojave stupnja ≥ 3 koje su se pojavile u > 5 % bolesnica bile su anemija (23 %), povišene vrijednosti ALT-a (10 %), umor/astenija (10 %), neutropenija (8 %), trombocitopenija (6 %) i mučnina (5 %).
• Do not breast-feed during treatment with Rubraca, and for two weeks after taking the last dose.
• Nemojte dojiti tijekom liječenja lijekom Rubraca te još dva tjedna od uzimanja posljednje doze.
In the tBRCA population, 31% of patients (40/130) in the rucaparib group and 35% of patients (23/66) in the placebo group had measurable disease at baseline.
U populaciji s tBRCA-om, 31 % ispitanica (40/130) u skupini koja je primala rukaparib i 35 % ispitanica (23/66) u skupini koja je primala placebo imalo je mjerljivu bolest na početku ispitivanja.
In vitro, rucaparib reversibly inhibited CYP1A2, CYP2C19, CYP2C9, and CYP3A, and to a lesser extent CYP2C8, CYP2D6, and UGT1A1.
In vitro, rukaparib je reverzibilno inhibirao CYP1A2, CYP2C19, CYP2C9 i CYP3A i u manjoj mjeri CYP2C8, CYP2D6 i UGT1A1.
• medicines to treat migraines and headaches - such as dihydroergotamine or ergotamine
• lijekove za liječenje migrena i glavobolja - kao što su dihidroergotamin ili ergotamin
There are limited clinical data in patients with moderate or severe hepatic impairment (ie, any total bilirubin greater than 1.5 times ULN), therefore rucaparib is not recommended for use in patients with moderate or severe hepatic impairment.
Postoje ograničeni klinički podaci u bolesnica s umjerenim ili teškim oštećenjem funkcije jetre (tj. svaka vrijednost ukupnog bilirubina veća od 1,5-struke vrijednosti GGN), stoga se rukaparib ne preporučuje za primjenu u bolesnica s umjerenim ili teškim oštećenjem funkcije jetre.
• medicines to treat stomach problems - such as cisapride, omeprazole
• lijekove za liječenje želučanih problema - kao što je cisaprid, omeprazol
• anticoagulant medicines which helps the blood flow freely, such as warfarin
• antikoagulanse koji pomažu u nesmetanom protoku krvi - kao što je varfarin
The primary efficacy outcome was investigator-assessed progression-free survival (invPFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1).
Response Evaluation Criteria in Solid Tumours, RECIST), verzija 1.1 (v1.1).
In vitro, rucaparib is metabolised primarily by CYP2D6, and to a lesser extent by CYP1A2, and CYP3A4.
In vitro, rukaparib se metabolizira primarno pomoću CYP2D6, a u manjoj mjeri pomoću CYP1A2 i CYP3A4.
CI: Confidence interval
NP: Nije postignuto CI: Interval pouzdanosti
In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies of some adverse reactions increased: Grade 3 or 4 anaemia (31%), Grade 3 or 4 thrombocytopenia (12%), and Grade 3 fatigue/asthenia (15%) were higher than in patients with mild renal impairment (CLcr > 59-80 mL/min) or normal renal function (CLcr > 80 mL/min) (21%, 5%, and 8%).
U bolesnica s umjereno oštećenom funkcijom bubrega (CLcr od 30-59 ml/min), učestalosti nekih nuspojava su se povećale: anemija 3. ili 4. stupnja (31 %), trombocitopenija 3. ili 4. stupnja (12 %) i umor/astenija 3. stupnja (15 %) bile su više nego u bolesnica sa umjereno oštećenom funkcijom bubrega (CLcr > 59-80 ml/min) ili normalnom funkcijom bubrega (CLcr > 80 ml/min) (21 %, 5 % i
Data suggest that rucaparib is a moderate inhibitor of CYP1A2, and a mild inhibitor of CYP2C9, CYP2C19, and CYP3A.
Podaci ukazuju da je rukaparib umjereni inhibitor CYP1A2 i blagi inhibitor CYP2C9, CYP2C19 i CYP3A.
• medicines used to treat asthma - such as theophylline
• lijekove koji se koriste za liječenje astme - kao što je teofilin
Caution should be exercised and additional International Normalised Ratio (INR) monitoring with co-administration of warfarin and therapeutic drug level monitoring of phenytoin should be considered, if used concomitantly with rucaparib.
International Normalised Ratio, INR) kod istodobne primjene varfarina odnosno praćenje terapijske razine fenitoina ako se primjenjuje istodobno s rukaparibom.
A population PK analysis was performed to evaluate the effect of renal impairment on the clearance of rucaparib in patients receiving rucaparib 600 mg twice daily.
Populacijska PK analiza provedena je za procjenu učinka oštećenja funkcije jetre na klirens rukapariba u bolesnica koje su primale 600 mg dva puta dnevno.
In an exploratory analysis, a response was noted in 38% (95% CI 23% - 54%) of patients (n=15) on rucaparib compared to 9% (95% CI 1%28%) of patients (n=2) on placebo (2-sided p-value = 0.0055), including 7 (18%) patients in the rucaparib group who achieved a complete remission.
Pri eksplorativnoj analizi zabilježen je odgovor u 38 % (95 % CI 23 % - 54 %) ispitanica (n = 15) za rukaparib u odnosu na 9 % (95 % CI 1 % - 28 %) ispitanica (n = 2) za placebo (dvostrana p vrijednost = 0,0055), uključujući 7 ispitanica (18 %) u skupini koja je primala rukaparib koje su postigle potpunu remisiju.
If a patient vomits after taking Rubraca, the patient should not retake the dose and should take the next scheduled dose.
Ako bolesnica povrati nakon uzimanja lijeka Rubraca, ne smije ponovno uzeti dozu već sljedeću dozu treba uzeti u uobičajeno vrijeme predviđeno za sljedeću dozu.
Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
Učinak P-gp i BCRP inhibitora na PK rukapariba ne može se isključiti.
Increased blood creatinine, Hypercholesterolaemiab
Manje često povišene vrijednosti kreatinina u krvi, hiperkolesterolemijab
In an exploratory analysis in this subgroup, a response was noted in 18% (95% CI 12% - 26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% - 17%) of patients (n=5) on placebo (2-sided p-value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.
Pri istraživačkoj analizi te podskupine zabilježen je odgovor u 18 % (95 % CI 12 % - 26 %) ispitanica (n = 26) koje su primale rukaparib u odnosu na 8 % (95 % CI 3 % - 17 %) ispitanica (n = 5) koje su primale placebo (dvostrana p vrijednost = 0,0069), uključujući 10 ispitanica (7 %) u skupini koja je primala rukaparib koje su postigle potpunu remisiju.
Nervous system disorders Very common
Poremećaji živčanog sustava Vrlo često disgeuzija, vrtoglavica
If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Rubraca should be discontinued.
Ako se potvrdi MDS/AML nakon ispitivanja vezano uz produljenu hematološku toksičnost, s primjenom lijeka Rubraca je potrebno prestati.
Median progression-free survival - days (95% CI)
Medijan preživljenja bez progresije - u danima (95 % CI)
• Tablet coating: - Rubraca 200 mg film-coated tablets Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133) and indigo carmine aluminium lake (E132).
• Ovojnica tablete: - Rubraca 200 mg filmom obložene tablete: Poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 4000 (E1521), talk (E553b), brilliant blue FCF aluminium lake (E133) i indigo carmine aluminium lake
• anticonvulsant medicines used to treat fits (seizures) and epilepsy - such as phenytoin
• antikonvulzante koji se koriste u liječenju napadaja i epilepsije - kao što je fenitoin
Most patients could continue rucaparib with or without treatment modification without recurrence of
Većina bolesnica mogla je nastaviti primati rukaparib bez ili uz prilagodbu liječenja a bez ponovne pojave abnormalnosti u testovima funkcije jetre ≥ 3. stupnja.
In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
In vitro, rukaparib je snažan inhibitor MATE1 i MATE2-K, umjeren inhibitor OCT1 i slab inhibitor OCT2.
Fertility studies have not been conducted with rucaparib.
Nisu provedena ispitivanja plodnosti s rukaparibom.
Patients with Renal Impairment
Bolesnice s oštećenom funkcijom bubrega
No studies have been conducted to investigate the pharmacokinetics of rucaparib in paediatric patients.
Nisu provedena ispitivanja farmakokinetike rukapariba u pedijatrijskoj populaciji.
PFS events, n (%) PFS, median in months (95% CI)
PFS, medijan u mjesecima (95
There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Nije obavezno testiranje na gen BRCA prije primjene lijeka Rubraca za terapiju održavanja u odraslih bolesnica s relapsnim epitelnim rakom jajnika (engl. epithelial ovarian cancer, EOC), jajovoda (engl. fallopian tube cancer, FTC) ili primarnim peritonealnim rakom (engl. primary peritoneal cancer, PPC) visokog gradusa koje imaju potpun ili djelomičan odgovor na kemoterapiju na bazi platine.
• Tablet content: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate.
• Sadržaj tablete: mikrokristalična celuloza, natrijev škroboglikolat (vrsta A), koloidni, bezvodni silicijev dioksid i magnezijev stearat
PAES: In order to further investigate the efficacy of rucaparib maintenance treatment in patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, the MAH should submit the final analysis of OS and updated analyses of PFS2, chemotherapy-free interval and time to start of subsequent anti-cancer treatment of the phase 3, randomised, double-blind study CO-338-014
Ispitivanje djelotvornosti nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Kako bi se dodatno ispitala djelotvornost rukapariba u terapiji održavanja u bolesnica s relapsnim epitelnim rakom jajnika, jajovoda ili primarnim peritonealnim rakom visokog gradusa, koje imaju odgovor (potpuni ili djelomični) na kemoterapiju na bazi platine, nositelj odobrenja treba dostaviti konačnu analizu ukupnog preživljenja (OS) i ažurirane analize za PFS2, interval bez kemoterapije i vrijeme početka sljedećeg antitumorskog liječenja u okviru randomiziranog, dvostruko slijepog ispitivanja faze 3 CO-338-014.
Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome, Erythema
Često makulo-papularni osip, sindrom palmarno-plantarne eritrodizestezije, eritem
Study 10 population characteristics in 42 patients were: median age 57 years (range 42 to 84), white (83%), ECOG performance status 0 (62%) or 1 (38%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (36%), median time since ovarian cancer diagnosis 43 months [range: 6178], median progression-free interval from the last platinum treatment 8.0 months [range: 6.0
Karakteristike populacije Ispitivanja 10 na 42 bolesnice bile su: medijan dobi od 57 godina (raspon 42 do 84), bjelkinje (83 %), funkcionalni status prema ECOG-u bio je 0 (62 %) ili 1 (38 %), rak jajnika visokog gradusa (100 %), 3 ili više prethodnih linija kemoterapije (36 %), medijan vremena od dijagnoze raka jajnika iznosio je 43 mjeseca [raspon: 6 - 178], medijan intervala bez progresije od posljednjeg liječenja platinom iznosio je 8,0 mjeseci [raspon: 6,0 - 116,4].
In the ITT population, 38% of patients (141/375) in the rucaparib group and 35% of patients (66/189) in the placebo group had measurable disease at baseline.
U populaciji ITT, 38 % ispitanica (141/375) u skupini koja je primala rukaparib i 35 % ispitanica (66/189) u skupini koja je primala placebo imalo je mjerljivu bolest na početku ispitivanja.
In patients ≥ 75 years old, frequencies of some adverse reactions increased: increased blood creatinine (32%), dizziness (20%), pruritus (15%), and memory impairment (4%) were higher than in patients < 75 years old (18%, 15%, 9% and 1% respectively).
≥ 75 godina, učestalosti nekih nuspojava su se povećale: povišen kreatinin u krvi (32 %), omaglica (20 %), pruritus (15 %) i poremećaj pamćenja (4 %) bile su više nego u bolesnica u dobi
This is because Rubraca can cause low blood counts of:
To je stoga što pretrage krvi mogu pokazati nizak broj krvnih stanica:
Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions
Tablični prikaz nuspojava prema MedDRA klasifikaciji organskih sustava Nuspojave
Decreased appetite, Increased blood creatinineb
Vrlo često smanjen apetit, povišene vrijednosti kreatinina u krvib
Blood samples for 94% (186/196) of the tBRCA patients were evaluated using a central blood germline BRCA (gBRCA) test. Based on these results, 70% (130/186) of the tBRCA patients had a gBRCA mutation and 30% (56/186) had a somatic BRCA mutation.
Na temelju tih rezultata, 70 % (130/186) bolesnica s tBRCA imalo je mutaciju gBRCA, a 30 % (56/186) imalo je somatsku mutaciju gena BRCA.
Median duration of responsea - days (95% CI)
Medijan trajanja odgovoraa - u danima (95 %
Rucaparib increased S-warfarin Cmax by 1.05 fold (90% CI: 0.99 to 1.12) and AUC0-96h by 1.49 fold (90% CI: 1.40 to 1.58), respectively.
Rukaparib je povećao Cmax S-varfarina za 1,05 puta (90% CI: 0,99; 1,12) i AUC0-96h za 1,49 puta (90 % CI: 1,40; 1,58).
Microcrystalline cellulose Sodium starch glycolate (Type A) Colloidal anhydrous silica Magnesium stearate
Jezgra tablete mikrokristalična celuloza natrijev škroboglikolat (vrsta A) silicijev dioksid, koloidni, bezvodni magnezijev stearat
Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Rukaparib je snažan inhibitor MATE1 i MATE2-K, umjeren inhibitor OCT1 te slab inhibitor OCT2.
Potential in vivo BCRP inhibition cannot be excluded.
Ne može se isključiti potencijalna in vivo BCRP
Thrombocytopeniab, Neutropeniab, Febrile neutropenia, Leukopeniab
Često trombocitopenijab, neutropenijab, febrilna neutropenija, leukopenijab
Increased transaminases
Često povišene vrijednosti transaminazab
ARIEL2 population characteristics in 64 patients were: median age 60 years (range 33 to 80), white(75%), ECOG performance status 0 (61%) or 1 (39%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (78%), median time since ovarian cancer diagnosis 53 months [range: 22-197], median progression-free interval from the last platinum treatment 7.6 months [range:
Karakteristike populacije ispitivanja ARIEL2 u 64 bolesnice bile su: medijan dobi od 60 godina (raspon 33 do 80), bjelkinje (75 %), funkcionalno stanje prema Istočnoj kooperativnoj onkološkoj skupini bilo je 0 (61 %) ili 1 (39 %), rak jajnika visokog gradusa (100%), 3 ili više prethodnih linija kemoterapije (78 %), medijan vremena od dijagnoze raka jajnika iznosio je 53 mjeseca [raspon: 22 - 197], medijan intervala bez progresije od posljednjeg liječenja platinom iznosio je 7,6 mjeseci [raspon: 0,7 - 26,5].
Summary of primary efficacy findings for patients with BRCA-mutant ovarian cancer who received rucaparib 600 mg twice daily and two or more prior chemotherapy regimens based on investigator assessment of response
Tablica 5. Sažetak rezultata primarnog ishoda djelotvornosti na osnovu ispitivačeve procjene odgovora za bolesnice s rakom jajnika s BRCA mutacijama koje su primale rukaparib 600 mg dvaput dnevno i dva ili više prethodnih režima kemoterapije
Randomisation was stratified by best response to last platinum therapy (complete or partial), time to progression following the penultimate platinum therapy (6 to ≤ 12 months and > 12
Randomizacija je stratificirana prema najboljem odgovoru na posljednju terapiju platinom (potpuni ili djelomični), vremenu do progresije bolesti nakon pretposljednje terapije platinom (6 do ≤ 12 mjeseci i > 12 mjeseci) te statusu tumorskih biomarkera (tBRCA, deficijencija homologne rekombinacije koja nije BRCA [nbHRD] i negativni biomarkeri).
Very common
Često umorc
Tablet coating Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000 (E1521)
Ovojnica tablete Poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 4000 (E1521)
No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Nije potrebna prilagodba početne doze u bolesnica s blagim ili umjerenim oštećenjem funkcije bubrega (vidjeti dio 5.2).
Medicinal product interactions
Interakcije lijeka
b. Two-sided p-value c. HRD includes all patients with a deleterious germline or somatic BRCA mutation or non-tBRCA with high genomic loss of heterozygosity, as determined by the clinical trial assay (CTA).
HRD uključuje sve ispitanice sa štetnom germinativnom ili somatskom mutacijom u genu BRCA ili ispitanice bez tBRCA s visokim genomskim gubitkom heterozigotnosti, koji utvrđuje test kliničkog ispitivanja (engl.