natgillin/translations-raw huggingface dataset:
In vitro, olaparib inhibits the efflux transporter P-gp (IC50 = 76 µM), therefore it cannot be excluded that olaparib may cause clinically relevant drug interactions with substrates of P-gp (e.g. simvastatin, pravastatin, dabigatran, digoxin and colchicine).
In vitro olaparib zavira efluksni prenašalec P-gp (IC50 = 76 µM), zato ni mogoče izključiti klinično pomembnih medsebojnih delovanj olapariba s substrati P-gp (npr. s simvastatinom, pravastatinom, dabigatranom, digoksinom in kolhicinom).
• The doses of Lynparza capsules and tablets are not the same.
• Odmerki zdravila v kapsulah in tabletah zdravila Lynparza niso enaki.
• statins, for example simvastatin, pravastatin, rosuvastatin - used to lower blood cholesterol levels
• statini, na primer simvastatin, pravastatin, rosuvastatin - uporabljajo se za zmanjševanje koncentracije holesterola v krvi,
PFS (51% maturity)
PFS (51 % zrelost)
Paediatric population No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients.
Pediatrična populacija Študij farmakokinetike olapariba pri pediatričnih bolnikih niso izvedli.
There are limited clinical data in patients aged 75 years and over.
Kliničnih podatkov o bolnikih, starih 75 let ali več, je malo.
Olaparib 300 mg bd n=205
olaparib 300 mg 2x na dan n = 205
Response to prior platinum chemotherapy was complete in 45% and partial in 55% of the patients.
Odziv na predhodno kemoterapijo na osnovi platine je bil popoln pri 45 % bolnic in delen pri 55 % bolnic.
Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2mutations, who have HER2 negative locally advanced or metastatic breast cancer.
Zdravilo Lynparza je indicirano kot monoterapija za zdravljenje odraslih bolnikov z germinalno mutacijo gena BRCA1/2, ki imajo HER2-negativnega lokalno napredovalega ali metastatskega raka dojk.
You should have received chemotherapy medicines either before or after your cancer has spread.
Pred ali po razširitvi raka ste morali prejemati zdravila za kemoterapijo.
Large rearrangements in the BRCA1/2 genes were detected in 5.5% (21/383) of the randomised patients.
Velike preureditve genov BRCA1/2 so ugotovili pri 5,5 % (21/383) randomiziranih bolnic.
• The doses of Lynparza tablets and capsules are not the same.
• Odmerki zdravila v tabletah in kapsulah zdravila Lynparza niso enaki.
Lynparza can be administered in patients with mild renal impairment (creatinine clearance 51 to 80 ml/min) with no dose adjustment.
Zdravilo Lynparza se lahko pri bolnikih z blago okvaro ledvic (očistek kreatinina 51 do 80 ml/min) uporablja brez prilagoditve odmerka.
Approximately a quarter of placebo-treated patients in the BRCA-mutated subgroup (14/62; 22.6%) received a subsequent PARP inhibitor.
Približno četrtina tistih bolnic v podskupini z mutacijo gena BRCA, ki so prejemale placebo (14/62, 22,6 %) je nato dobilo zaviralec PARP.
Maintenance treatment of platinum-sensitive relapsed (PSR) ovarian cancer SOLO2 Study
Vzdrževalno zdravljenje na platino občutljive ponovitve (PSR) raka jajčnikov Študija SOLO2
The metabolism of olaparib is extensive.
Presnova olapariba je obsežna.
Do not switch to Lynparza tablets unless your doctor tells you
Ne preidite na jemanje tablet zdravila Lynparza, razen če vam tako naroči zdravnik.
Lynparza monotherapy has been associated with adverse reactions generally of mild or moderate severity (CTCAE grade 1 or 2) and generally not requiring treatment discontinuation.
Monoterapija z zdravilom Lynparza je bila povezana z neželenimi učinki, ki so bili na splošno blage ali zmerne resnosti (stopnja po CTCAE 1 ali 2) in na splošno niso zahtevali prekinitve zdravljenja.
In the TNBC patient subgroup the confirmed ORR was 48% (41/86) in the olaparib arm and 12% (4/33) in the comparator arm.
V podskupini bolnikov s TNBC je bil potrjeni ORR 48 % (41/86) v skupini z olaparibom in 12 % (4/33) v skupini s primerjalnim zdravilom.
What Lynparza looks like and contents of the pack
Izgled zdravila Lynparza in vsebina pakiranja
There are very limited data in patients with a somatic BRCA mutation.
Podatkov pri bolnicah s somatskimi mutacijami gena BRCA je zelo malo.
Other special populations Limited safety data are available in elderly (age  75 years) and non-Caucasian patients.
Druge posebne skupine bolnikov Varnostnih podatkov pri starejših bolnikih (starih  75 let) in bolnikih, ki niso belci, je malo.
Patients must have received treatment with an anthracycline unless contraindicated and a taxane in either a (neo)adjuvant or metastatic setting.
Bolniki so morali prejemati zdravljenje z antraciklinom, razen če je bil kontraindiciran, in taksanom, bodisi v okviru (neo)adjuvantnega zdravljenja ali zdravljenja metastatske bolezni.
There was no strategy for multiple testing in place for the sub-group analyses.
Za analize podskupin ni bila uporabljena korekcija za večkratna testiranja.
• rash or itchy rash on swollen, reddened skin (dermatitis)
• izpuščaj ali srbeč izpuščaj na otekli, pordeli koži (dermatitis)
Detection of BRCA1/2 mutations
Odkrivanje mutacij genov BRCA1/2
• dabigatran - used to thin the blood
• dabigatran - uporablja se za redčenje krvi,
The pharmacokinetics of olaparib at the 300 mg tablet dose are characterised by an apparent plasma clearance of ~7 L/h, an apparent volume of distribution of ~158 L and a terminal half-life of 15 hours.
Farmakokinetika med uporabo olapariba v tabletah 300 mg kaže navidezni plazemski očistek ~7 L/uro, navidezni volumen porazdelitve ~158 L in končni razpolovni čas 15 ur.
BRCA1/2 wt/VUS
Z mutacijo gena BRCA1/2 BRCA1/2 wt/VUS
Maintenance treatment of platinum sensitive relapsed ovarian cancer:
Vzdrževalno zdravljenje na platino občutljive ponovitve raka jajčnikov:
Secondary endpoints included PFS2, OS, objective response rate (ORR) and HRQoL.
Sekundarni opazovani dogodki so obsegali PFS2, OS, delež objektivnega odziva (ORR) in zdravstveno kakovost življenja (HRQoL).
You will be asked to take 6 capsules (300 mg) twice a day - a total of 12 capsules each day.
Jemati boste morali 6 kapsul (300 mg) dvakrat na dan - skupaj 12 kapsul vsak dan,
No placebo-treated patients discontinued due to vomiting or dyspepsia.
Nobena prejemnica placeba ni prekinila zdravljenja zaradi bruhanja ali dispepsije.
Median age was 59 years in both arms.
Mediana starost je bila v obeh skupinah 59 let.
• changes in taste of foods (dysgeusia)
• spremenjeno okušanje hrane (dizgevzija)
All patients comprises of the following subgroups: BRCA1/2-mutated, BRCA1/2 wt/VUS and BRCA1/2 status unknown (11 patients with status unknown, not shown as a separate subgroup in table).
Vse bolnice obsega naslednje podskupine: mutacijo gena BRCA1/2, BRCA1/2 wt/VUS in neznano stanje BRCA1/2 (11 bolnic z neznanim statusom, v preglednici niso prikazane kot ločena podskupina).
After a number of rounds of replication, genomic instability can reach insupportable levels and result in cancer cell death, as cancer cells have a high DNA damage load relative to normal cells.
Po številnih ponovitvah replikacije lahko genomska nestabilnost doseže nevzdržno raven in povzroči odmrtje rakave celice, ker imajo rakave celice v primerjavi z normalnimi veliko okvar DNA.
• glibenclamide, metformin, repaglinide - used to treat diabetes
• glibenklamid, metformin, repaglinid - uporabljajo se za zdravljenje sladkorne bolezni,
Nausea was generally reported very early, with first onset within the first month of Lynparza treatment in the majority of patients.
O navzei so na splošno poročali zelo zgodaj in se je pri večini bolnic prvič pojavila v prvem mesecu zdravljenja z zdravilom Lynparza.
Patients who take Lynparza may experience fatigue, asthenia or dizziness.
Bolnikom, ki jemljejo zdravilo Lynparza, se lahko pojavijo utrujenost, astenija ali omotica.
Median age was 56 years in both arms.
Mediana starost je bila v obeh skupinah 56 let.
It is also not recommended to consume grapefruit juice while on Lynparza therapy as it is a CYP3A inhibitor.
Prav tako med zdravljenjem z zdravilom Lynparza ni priporočljivo pitje grenivkinega soka, ker ta zavira CYP3A.
The majority of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers.
Večina opisanih primerov je bilo pri nosilkah germinalne mutacije gena dovzetnosti za raka dojk 1 ali 2 (gBRCA1/2).
Based on Kaplan-Meier estimates, the proportion of patients that were progression free at 24 and 36 months were 74% and 60% for olaparib versus 35% and 27% for placebo; the median follow-up time was 41 months for both the olaparib and placebo arms.
Na podlagi Kaplan-Meierjevih ocen je bil delež bolnic brez napredovanja bolezni v skupini z olaparibom po 24 mesecih 74 % in po 36 mesecih 60 %, v skupini s placebom pa sta bila ta deleža 35 % in 27 %; mediani čas spremljanja je bil 41 mesecev tako v skupini z olaparibom kot v skupini s placebom.
All patients had evidence of gBRCA1/2m at baseline.
Vse bolnice so imele izhodiščno potrjeno gBRCA1/2m.
In rat embryofoetal development studies, and at dose levels that did not induce significant maternal toxicity, olaparib caused reduced embryofoetal survival, reduced foetal weight and foetal developmental abnormalities, including major eye malformations (e.g. anophthalmia, microphthalmia), vertebral/rib malformation and visceral and skeletal abnormalities.
V študijah embrio-fetalnega razvoja pri podganah je olaparib v odmerkih, ki niso imeli pomembnih toksičnih učinkov pri samicah-materah, zmanjšal embrio-fetalno preživetje in telesno maso plodov ter je povzročil razvojne nepravilnosti plodov vključno s hudimi malformacijami oči (npr. anoftalmijo, mikroftalmijo), malformacije vretenc oziroma reber ter visceralne in skeletne nepravilnosti.
Co-administration with food slowed the rate (tmax delayed by 2 hours) and marginally increased the extent of absorption of olaparib (AUC increased by approximately 20%).
Sočasna uporaba s hrano je upočasnila hitrost absorpcije (podaljšanje tmax za 2 uri) in mejno povečala obseg absorpcije olapariba (povečanje vrednosti AUC za približno 20 %).
It can be used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Uporabi se lahko potem, ko se je rak odzval na predhodno zdravljenje s standardno kemoterapijo na osnovi platine.
The efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib (see also sections 4.4 and 4.6).
Učinkovitost nekaterih hormonskih kontraceptivov se lahko zmanjša, če so uporabljeni sočasno z olaparibom (glejte tudi poglavji 4.4 in 4.6).
The recommended Lynparza monotherapy dose is not suitable for combination with myelosuppressive anticancer medicinal products.
Zdravilo Lynparza se uporablja kot monoterapija in ni primerno za uporabo v kombinaciji z mielosupresivnimi zdravili proti raku.
Up to 20, 37 and 20 metabolites were detected in plasma, urine and faeces, respectively, the majority of them representing < 1% of the dosed material.
V plazmi so odkrili do 20 presnovkov, v urinu do 37 in v blatu do 20; večina od teh je predstavljala < 1 % uporabljenega zdravila.
As subsequent therapy, 0.5% and 8% of patients received a PARP inhibitor in the treatment and comparator arms, respectively; 29% and 42% of patients, respectively, received subsequent platinum therapy.
Kot nadaljnje zdravljenje je 0,5 % bolnikov v terapevtski in 8 % bolnikov v primerjalni skupini prejelo zaviralec PARP, 29 % bolnikov v prvi in 42 % v drugi skupini pa je v nadaljevanju prejelo zdravljenje s platino.
Pre-planned subgroup analysis by BRCA-mutation status identified patients with BRCA-mutated ovarian cancer (n=136, 51.3%) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
Poleg tega je vnaprej načrtovana analiza podskupin po mutacijskem stanju gena BRCA pokazala, da so bolnice z rakom jajčnikov in mutacijo gena BRCA (n = 136, 51,3 %) tista podskupina, ki ji je vzdrževalna monoterapija z olaparibom klinično najbolj koristila.
Baseline testing, followed by monthly monitoring, of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment (see section 4.8).
Preiskava celotne krvne slike je priporočljiva na začetku zdravljenja, potem vsak mesec prvih 12 mesecev zdravljenja in pozneje redno, da bi odkrili klinično pomembne spremembe katere koli vrednosti med zdravljenjem (glejte poglavje 4.8).
• You should have a pregnancy test before starting Lynparza, at regular times during treatment and 1 month after taking the last dose of Lynparza.
• Pred začetkom jemanja zdravila Lynparza morate opraviti test nosečnosti, ki ga morate ponavljati v rednih presledkih ves čas zdravljenja in še en mesec po vzetju zadnjega odmerka zdravila Lynparza.
Tell your doctor, pharmacist or nurse if you are taking any of the above or any other medicines.
Zdravniku, farmacevtu ali medicinski sestri povejte, če jemljete katero od navedenih zdravil ali katero koli drugo zdravilo.
PFS2 (65% maturity) - DCO 25 September 2017
PFS2 (65 % zrelost) - DCO 25. september 2017
• a type of ovarian cancer (BRCA-mutated) that has responded to the first treatment with standard platinum-based chemotherapy.
• raka jajčnikov posebne vrste (z mutacijo gena BRCA), ki se je odzval na prvo zdravljenje s standardno kemoterapijo na osnovi platine.
Each hard capsule contains 50 mg of olaparib.
Ena trda kapsula vsebuje 50 mg olapariba.
The efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib (see sections 4.4 and 4.6).
Učinkovitost nekaterih hormonskih kontraceptivov se lahko zmanjša, če so uporabljeni sočasno z olaparibom (glejte poglavji 4.4 in 4.6).
The duration of therapy with olaparib in patients who developed MDS/AML varied from < 6 months to > 2 years.
Pri bolnicah, ki so zbolele za MDS/AML, je zdravljenje z olaparibom trajalo od < 6 mesecev do > 2 leti.
In this study 391 patients were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or placebo.
V tej študiji so 391 bolnic v razmerju 2:1 randomizirali bodisi na prejemanje zdravila Lynparza (300 mg [2 x 150 mg v tabletah] dvakrat na dan) bodisi na prejemanje placeba.
Table 8
Slika 8.
Response to prior platinum chemotherapy was complete in 47% and partial in 53% of the patients.
Odziv na predhodno kemoterapijo na osnovi platine je bil popoln pri 47 % bolnic in delen pri 53 % bolnic.
Patients should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
Bolnice morajo začeti zdravljenje z zdravilom Lynparza najpozneje v 8 tednih po zadnjem odmerku sheme zdravljenja na osnovi platine.
Therefore, caution should be exercised when sensitive CYP3A substrates or substrates with a narrow therapeutic margin (e.g. simvastatin, cisapride, cyclosporine, ergot alkaloids, fentanyl, pimozide, sirolimus, tacrolimus and quetiapine) are combined with olaparib.
Zato je potrebna previdnost pri sočasni uporabi olapariba z občutljivimi substrati CYP3A4 ali substrati, ki imajo ozko terapevtsko okno (npr. s simvastatinom, cisapridom, ciklosporinom, ergot alkaloidi, fentanilom, pimozidom, sirolimusom, takrolimusom in kvetiapinom).
The analysis was performed using a Cox proportional hazard model including response to previous platinum chemotherapy (CR or PR), and time to disease progression (>6-12 months and >12 months) in the penultimate platinum-based chemotherapy as covariates.
Analiza je bila narejena s Coxovim modelom sorazmernih ogroženosti, ki je kot sospremenljivko vključeval odziv na predhodno kemoterapijo na osnovi platine (CR ali PR) in časom do napredovanja bolezni (> 6-12 mesecev ali več kot 12 mesecev) med predzadnjo kemoterapijo na osnovi platine.
Treatment may be interrupted to manage adverse reactions such as nausea, vomiting, diarrhoea, and anaemia and dose reduction can be considered (see section 4.8).
Zdravljenje je mogoče prekiniti za obvladanje neželenih učinkov, kot so navzea, bruhanje, driska ali anemija; v poštev pride zmanjšanje odmerka (glejte poglavje 4.8).
There were 389 patients who were germline BRCA1/2m and 2 who were somatic BRCA1/2m in SOLO1.
V študiji SOLO1 je bilo 389 bolnic z germinalno BRCA1/2m in 2 s somatsko BRCA1/2m.
P value (2-sided)
Vrednost p (2-stranska)
A clinical study to evaluate the impact of rifampicin, a known CYP3A inducer, has shown that co-administration with olaparib decreased olaparib mean Cmax by 71% (90% CI: 76-67%) and mean AUC by 87% (90% CI: 89-84%).
Klinična študija za oceno vpliva rifampicina, ki je znan induktor CYP3A, je pokazala, da je njegova sočasna uporaba z olaparibom zmanjšala srednjo vrednost Cmax olapariba za 71 % (90 % IZ: 76 do 67 %) in srednjo vrednost AUC olapariba za 87 % (90 % IZ: 89 do 84 %).
If pneumonitis is confirmed, Lynparza treatment should be discontinued and the patient treated appropriately.
Če je pnevmonitis potrjen, je treba zdravljenje z zdravilom Lynparza prekiniti in bolnika ustrezno zdraviti.
Capsule content Lauroyl macrogol-32 glycerides
Vsebina kapsule makrogolglicerol lavrat-32
Vomiting was reported early, with first onset within the first two months of Lynparza treatment in the majority of patients.
O bruhanju so poročali zgodaj in se je pri večini bolnic prvič pojavilo v prvih dveh mesecih zdravljenja z zdravilom Lynparza.
Patients with PR at study entry either achieved CR (15% in olaparib arm and 4% in the placebo arm at 24 months, remained in CR at 36 months) or had further PR/stable disease (43% in olaparib arm and 15% in the placebo arm at 24 months; 17% in olaparib arm and 15% in placebo arm at 36 months).
Bolnice z delnim odzivom (PR) ob vstopu v študijo so bodisi dosegle popoln odziv (CR) (15 % v skupini z olaparibom in 4 % v skupini s placebom po 24 mesecih; so ostale v popolnem odzivu (CR) po 36 mesecih) bodisi so bile še naprej v delnem odzivu (PR)/imele stabilno bolezen (43 % v skupini z olaparibom in 15 % v skupini s placebom po 24 mesecih; 17 % v skupini z olaparibom in 15 % v skupini s placebom po 36 mesecih).
If you take more Lynparza than your normal dose, contact your doctor or nearest hospital straight away.
Če ste vzeli večji odmerek zdravila Lynparza, kot bi smeli Če vzamete odmerek zdravila Lynparza, ki je večji od vašega normalnega odmerka, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
The pharmacokinetics of olaparib at the 400 mg twice daily capsule dose are characterised by an apparent plasma clearance of ~8.6 L/h, an apparent volume of distribution of ~167 L and a terminal half-life of 11.9 hours.
Farmakokinetika med uporabo olapariba v kapsulah 400 mg dvakrat na dan kaže navidezni plazemski očistek ~8,6 L/uro, navidezni volumen porazdelitve ~167 L in končni razpolovni čas 11,9 ure.
PFS (77% maturity) - DCO 09 December 2016
PFS (77 % zrelost) - DCO 09. december 2016
Film-coated tablets Multipack: 112 (2 packs of 56) film-coated tablets
filmsko obložene tablete skupno pakiranje: 112 (2 pakiranji po 56) filmsko obloženih tablet
The most frequent adverse reactions leading to dose interruption or dose reduction were anaemia, nausea and vomiting.
Najpogostejši neželeni učinki, ki so povzročili prekinitev uporabe ali zmanjšanje odmerka, so bili anemija, navzea in bruhanje.
• fentanyl - used to treat cancer pain
• fentanil - uporablja se za zdravljenje bolečin zaradi raka,
• herbal remedies containing St John's Wort (Hypericum perforatum) - used mainly for depression
• zeliščna zdravila, ki vsebujejo šentjanževko (Hypericum perforatum) - v glavnem se uporablja za zdravljenje depresije,
Median age was 53 years in both arms.
Mediana starost je bila v obeh skupinah 53 let.
The most frequently observed adverse reactions across clinical trials in patients receiving Lynparza monotherapy (≥ 10%) were nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness, upper abdominal pain, cough, dyspnoea, anaemia, neutropenia, thrombocytopenia and leukopenia.
V kliničnih preizkušanjih so pri monoterapiji z zdravilom Lynparza najpogosteje (≥ 10 %) opažali naslednje neželene učinke: navzeo, bruhanje, drisko, dispepsijo, utrujenost, glavobol, motnje okušanja, zmanjšanje apetita, omotico, bolečine v zgornjem delu trebuha, kašelj, dispnejo, anemijo, nevtropenijo, trombocitopenijo in levkopenijo.
Adverse reactions that most commonly led to permanent discontinuation were anaemia (1.3%), nausea (0.8%) and thrombocytopenia (0.5%).
Neželeni učinki, ki so najpogosteje povzročili trajno prenehanje uporabe, so bili anemija (1,3 %), navzea (0,8 %) in trombocitopenija (0,5 %).
In patients with mild hepatic impairment (Child-Pugh classification A), AUC increased by 15% and Cmax by 13% and in patients with moderate hepatic impairment (Child-Pugh classification B), AUC increased by 8% and Cmax decreased by 13% compared with patients with normal hepatic function.
Pri bolnicah z blago okvaro jeter (klasifikacija Child-Pugh A) se je vrednost AUC povečala za 15 % in vrednost Cmax za 13 %, pri bolnicah z zmerno okvaro jeter (klasifikacija Child-Pugh B) pa se je vrednost AUC povečala za 8 % medtem ko se je vrednost Cmax zmanjšala za 13 % v primerjavi z bolnicami z normalnim delovanjem jeter.
Following oral administration of olaparib via the tablet formulation (2 x 150 mg), absorption is rapid with median peak plasma concentrations typically achieved 1.5 hours after dosing.
Po peroralni uporabi olapariba v obliki tablet (dvakrat 150 mg) je absorpcija hitra in mediana največja koncentracija v plazmi je praviloma dosežena 1,5 ur po uporabi.
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.
Moški bolniki morajo med zdravljenjem in še 3 mesece po prejetju zadnjega odmerka zdravila Lynparza med spolnimi odnosi z nosečo žensko ali žensko v rodni dobi uporabljati kondom.
Therefore, caution should be taken if these medicinal products are co-administered with Lynparza and patients should be closely monitored.
Zato je v primeru sočasne uporabe teh zdravil in zdravila Lynparza potrebna previdnost, bolnike pa je potrebno skrbno spremljati.
If you think any of these may apply to you, talk to your doctor, pharmacist or nurse before or during treatment with Lynparza.
Če menite, da kaj od tega velja za vas, se pred začetkom zdravljenja z zdravilom Lynparza ali med zdravljenjem z njim posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In first-line ovarian cancer maintenance treatment, patients experienced nausea events (77% on olaparib, 38% on placebo), vomiting (40% on olaparib, 15% on placebo), diarrhoea (34% on olaparib, 25% on placebo) and dyspepsia (17% on olaparib, 12% on placebo).
Med vzdrževalnim zdravljenjem prve linije raka jajčnikov so se bolnicam pojavili navzea (77 % pri olaparibu, 38 % pri placebu), bruhanje (40 % pri olaparibu, 15 % pri placebu), driska (34 % pri olaparibu, 25 % pri placebu) in dispepsija (17 % pri olaparibu, 12 % pri placebu).
A ring-opened piperazin-3-ol moiety, and two mono-oxygenated metabolites (each ~10%) were the major circulating components, with one of the mono-oxygenated metabolites also being the major metabolite in the excreta (6% and 5% of the urinary and faecal radioactivity, respectively).
Glavne snovi v obtoku so bile piperazin-3-ol skupina z razklenjenim obročem in dva monooksigenirana presnovka (vsak ~10 %); eden od obeh monooksigeniranih presnovkov je bil tudi glavni izločeni presnovek (6 % radioaktivnosti v urinu in 5 % radioaktivnosti v blatu).
PR, defined as the presence of any measurable or non-measurable lesions at baseline or elevated CA-125, was reported in 27% and 23% of patients in the olaparib and placebo arms, respectively.
Delni odziv (PR), opredeljen kot prisotnost kakršne koli merljive ali nemerljive lezije izhodiščno ali zvišana raven CA-125, je imelo 27 % bolnic v skupini z olaparibom in 23 % bolnic v skupini s placebom.
Anaemia was the most common CTCAE grade ≥3 adverse reaction reported in clinical studies.
Anemija je bila v kliničnih študijah najpogosteje zabeleženi neželeni učinek ≥ 3. stopnje po CTCAE.