natgillin/translations-raw huggingface dataset:
Treatment was continued until radiological progression of the underlying disease, unacceptable toxicity or for up to 2 years.
Zdravljenje se je nadaljevalo do radiološkega napredovanja osnovne bolezni, nesprejemljive toksičnosti ali do največ 2 leti.
Proportion of patients event free
Delež bolnic brez dogodka
• protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine,
• zaviralce proteaz okrepljene z ritonavirjem ali kobicistatom, boceprevir, telaprevir, nevirapin,
These may be low counts for red or white blood cells or low platelet counts.
Lahko imate majhno število rdečih ali belih krvnih celic ali majhno število krvnih ploščic.
Chemotherapy (N = 97) Olaparib 300 mg twice daily (N = 205)
Kemoterapija (N = 97) Olaparib 300 mg dvakrat na dan (N = 205)
Detection of BRCA mutation
Ugotavljanje mutacije gena BRCA
Alu/Alu non-perforated blister containing 8 film-coated tablets.
Alu/Alu neperforirani pretisni omot z 8 filmsko obloženimi tabletami.
Levels appeared to return to normal after treatment discontinuation and did not appear to have any clinical consequences.
Vrednosti so se po prekinitvi zdravljenja normalizirale in po vsem sodeč ni bilo nobenih kliničnih posledic.
See section 4 for more information about these side effects, including the signs and symptoms you need to look out for (for example, fever or infection, bruising or bleeding).
Za informacije o teh neželenih učinkih glejte poglavje 4, vključno z znaki in simptomi, na katere morate biti pozorni (npr. vročina ali okužba, podplutbe ali krvavitev).
BRCA mutation status should be determined by an experienced laboratory using a validated test method (see section 5.1).
Mutacijsko stanje gena BRCA mora določiti izkušen laboratorij z validirano testno metodo (glejte poglavje 5.1).
• It is not known whether Lynparza passes into breast milk.
• Ni znano, ali zdravilo Lynparza prehaja v materino mleko.
The analysis was performed using a Cox proportional hazards model with factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Analiza je bila narejena s Coxovim modelom sorazmernih ogroženosti s faktorji za zdravljenje, etnično poreklo, občutljivost na platino in odziv na končno zdravljenje s platino.
On multiple dosing, an AUC accumulation ratio of 1.8 was observed and PK appeared to be time-dependent to a small extent.
Med uporabo večkratnih odmerkov je bil opaženi akumulacijski delež AUC 1,8 in farmakokinetika je bila v majhni meri odvisna od časa.
The majority of the metabolism was attributable to oxidation reactions with a number of the components produced undergoing subsequent glucuronide or sulfate conjugation.
Večina presnove poteka z oksidacijskimi reakcijami; pri tem nastanejo številne snovi, ki se nato konjugirajo z glukuronidom ali sulfatom.
Patients had tumour assessments at baseline and every 12 weeks for 3 years, and then every 24 weeks relative to date of randomisation, until objective radiological disease progression.
Bolnicam so ocene tumorja opravili izhodiščno, 3 leta vsakih 12 tednov ter nato na 24 tednov glede na datum randomizacije, do objektivnega radiološkega napredovanja bolezni.
Missing Number of prior lines of chemotherapy for metastatic breast cancer (%)
Število predhodnih kemoterapij za metastatskega raka dojk (%)
A pregnancy test should be performed on all women of childbearing potential prior to treatment and considered regularly throughout treatment.
Pri vseh ženskah v rodni dobi je potrebno pred zdravljenjem opraviti test nosečnosti in ga redno izvajati med celotnim zdravljenjem.
efavirenz - used for viral infections, including HIV
efavirenz - uporabljajo se za zdravljenje virusnih okužb, vključno s HIV,
Combination of olaparib with vaccines or immunosuppressant agents has not been studied.
Sočasna uporaba olapariba s cepivi ali imunosupresivnimi zdravili ni raziskana.
No adjustment in starting dose is required for elderly patients.
Starejšim bolnikom začetnega odmerka ni treba prilagoditi.
TNBC gBRCA mutation type (%) gBRCA1 gBRCA2 gBRCA1 and gBRCA2 ≥2 Metastatic sites (%) Location of the metastasis (%) Bone only
Tip mutacije gBRCA (%) gBRCA1 gBRCA2 gBRCA1 in gBRCA2 ≥ 2 metastatski mesti (%) Mesto metastaz (%) Samo kosti
However, no dose adjustment is required on the basis of ethnicity (see section 5.2).
Vendar odmerka ni treba prilagoditi glede na etnično poreklo (glejte poglavje 5.2).
Seven male patients were randomised (5 olaparib and 2 comparator).
Randomiziranih je bilo 7 moških bolnikov (5 na olaparib in 2 na primerjalno zdravilo).
Median time to first onset of anaemia was approximately 4 weeks (approximately 7 weeks for CTCAE grade ≥3 events).
Mediani čas do prvega pojava anemije je bil približno 4 tedne (približno 7 tednov za dogodke ≥ 3. stopnje po CTCAE).
For patients who remained in complete clinical response (i.e. no radiological evidence of disease), the maximum duration of treatment was 2 years; however, patients who had evidence of disease that remained stable (i.e. no evidence of disease progression) could continue to receive Lynparza beyond 2 years.
Pri bolnicah, ki so ostale v popolnem kliničnem odzivu (tj. brez radioloških znakov bolezni), je bilo najdaljše trajanje zdravljenja 2 leti, bolnice z znaki bolezni, ki je ostala stabilna (tj. brez znakov napredovanja bolezni), pa so lahko zdravilo Lynparza prejemale več kot 2 leti.
The most common histological type was serous (> 90%), endometrioid histology was reported in 6% of the patients.
Najpogostejša histološka vrsta je bila serozna (> 90 %), endometrioidna histologija pa je bila opisana pri 6 % bolnic.
The safety profile is based on pooled data from 1,826 patients with solid tumours treated with Lynparza monotherapy in clinical trials at the recommended dose.
Varnostni profil temelji na kumulativnih podatkih 1826 bolnic s solidnimi tumorji, ki so bile v kliničnih preizkušanjih zdravljene z monoterapijo z zdravilom Lynparza v priporočenem odmerku.
A benefit was also observed in patients with BRCA1/2 wild-type/variants of uncertain significance (BRCA1/2 wt/VUS), although of a lesser magnitude.
Korist so opažali tudi pri bolnicah z genom BRCA1/2 divjega tipa/variantami negotovega pomena (BRCA1/2 wt/VUS), čeprav manjše velikosti.
If you become pregnant during this time, you must talk to your doctor straight away.
Če med tem časom zanosite, se morate nemudoma posvetovati z zdravnikom.
In animal studies, no effect on conception was observed but there are adverse effects on embryofoetal survival (see section 5.3).
V študijah na živalih niso opažali vpliva na spočetje, ugotovljeni pa so neželeni učinki na embrio-fetalno preživetje (glejte poglavje 5.3).
Measurable disease (%) Progressive disease at time of randomization (%) Tumour grade at diagnosis Well differentiated (G1) Moderately differentiated (G2) Poorly differentiated (G3) Undifferentiated (G4) Unassessable (GX)
Merljiva bolezen (%) Progresivna bolezen ob času randomizacije (%) Stopnja tumorja ob diagnozi Visoko diferenciran (G1) Zmerno diferenciran (G2) Slabo diferenciran (G3)
TSST- an approximation of PFS2 (DCO 09 May
TSST - približek PFS2 (DCO 9. maj
No previous treatment with a PARP inhibitor, including olaparib, was permitted.
Predhodno zdravljenje z zaviralci PARP, vključno z olaparibom, ni bilo dovoljeno.
If preferred, you can keep Lynparza capsules out of the refrigerator (below 30°C) for up to 3 months.
Če vam bolj ustreza, lahko kapsule zdravila Lynparza največ 3 mesece shranjujete izven hladilnika (pri temperaturi do 30 °C).
• sore mouth (stomatitis).
• vnetje v ustih (stomatitis)
• rifampicin, rifapentine, rifabutin - used for bacterial infections, including tuberculosis (TB)
• rifampicin, rifapentin, rifabutin - uporabljajo se za zdravljenje bakterijskih okužb, vključno s tuberkulozo (TB),
The proportion of patients who progressed within 6 months of the last dose of platinum-based chemotherapy was 3.5% for olaparib and 8.4% for placebo.
Delež bolnic, pri katerih je bolezen napredovala v 6 mesecih po zadnjem odmerku kemoterapije na osnovi platine, je bil za olaparib 3,5 % in za placebo 8,4 %.
Probability of progression free survival
Verjetnost za preživetje brez napredovanja bolezni
Dose interruptions and reductions occurred most frequently in the first 3 months of treatment.
Prekinitve uporabe in zmanjšanja odmerka so bili najpogostejši v prvih 3 mesecih zdravljenja.
Carcinogenicity Carcinogenicity studies have not been conducted with olaparib.
Kancerogenost Študij kancerogenosti z olaparibom niso izvedli.
The study demonstrated a clinically relevant and statistically significant improvement in investigator assessed PFS for olaparib compared to placebo.
Študija je pokazala klinično pomembno in statistično značilno izboljšanje PFS po oceni raziskovalca za olaparib v primerjavi s placebom.
If you forget to take Lynparza
Če ste pozabili vzeti zdravilo Lynparza
Lynparza tablets may be taken without regard to meals.
Tablete zdravila Lynparza je mogoče jemati ne glede na obroke.
Female partners of male patients must also use highly effective contraception if they are of childbearing potential (see section 4.4).
Tudi partnerke moških bolnikov morajo uporabljati visoko učinkovito kontracepcijo, če so v rodni dobi (glejte poglavje 4.4).
If you are planning to breast-feed, tell your doctor.
Če nameravate dojiti, morate to povedati zdravniku.
Combination with anastrozole, letrozole and tamoxifen A clinical study has been performed to assess the combination of olaparib with anastrozole, letrozole or tamoxifen.
Kombinacija z anastrozolom, letrozolom in tamoksifenom Izvedli so klinično študijo za oceno kombinacije olapariba z anastrozolom, letrozolom in tamoksifenom.
In vitro, olaparib produced little/no inhibition of UGT1A4, UGT1A9, UGT2B7, or CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 and is not expected to be a clinically significant time dependent inhibitor of any of these CYP enzymes.
In vitro je olaparib le malo ali sploh nič zavrl UGT1A4, UGT1A9, UGT2B7 ali CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 ali 2E1 in ni pričakovati, da bi bil klinično pomemben časovno odvisen zaviralec katerega od encimov CYP.
• any other anticancer medicines
• katero koli drugo zdravilo proti raku,
Also, some other medicines can affect the way Lynparza works.
Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Lynparza.
The secondary endpoints TFST and PFS2 demonstrated a persistent and statistically significant improvement for olaparib compared with placebo (Table 4).
Sekundarna cilja študije TFST in PFS2 sta pokazala stalno in statistično značilno izboljšanje z olaparibom v primerjavi s placebom (preglednica 4).
Tests and checks Your doctor will check your blood before and during treatment with Lynparza.
Preiskave in kontrole Zdravnik vam bo pred zdravljenjem in med zdravljenjem z zdravilom Lynparza kontroliral kri.
Interval debulking surgery was performed in 35% of the patients and of these 82% had no macroscopic residual disease reported.
Intervalno je bila operacija za zmanjšanje tumorja opravljena pri 35 % teh bolnic in od teh jih 82 % ni imelo makroskopsko vidnih ostankov bolezni.
Paediatric population No studies have been conducted in paediatric patients.
Pediatrična populacija Študij pri pediatričnih bolnikih niso izvedli.
It is not known whether Lynparza may affect the effectiveness of some hormonal contraceptives.
Ni znano, ali zdravilo Lynparza poslabša učinkovitost nekaterih hormonskih kontraceptivov.
In cancers that lack functional components of HRR such as BRCA1 or 2, DNA DSBs cannot be repaired accurately or effectively.
Pri raku, ki nima funkcionalnih elementov HRR, kot sta BRCA1 ali 2, točno in učinkovito popravilo DSB DNA ni mogoče.
Male patients:
Moški bolniki:
It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.
Zdravljenje je priporočljivo nadaljevati do napredovanja osnovne bolezni ali nesprejemljive toksičnosti.
What Lynparza is and how it works
Kaj je zdravilo Lynparza in kako deluje
• Take Lynparza at least one hour after eating food.
• Zdravilo Lynparza vzemite vsaj eno uro po jedi.
Lynparza with drink
Zdravilo Lynparza skupaj s pijačo
(E172), iron oxide black (E172) (150 mg tablets only).
(E172), črni železov oksid (E172) (samo 150 mg tablete).
Table 7 Patient demographic and baseline characteristics in OlympiAD
Demografske in izhodiščne značilnosti bolnikov v študiji OlympiAD
Patients could have received prior bevacizumab, except in the regimen immediately prior to randomisation.
Bolnice so predhodno lahko prejemale bevacizumab, razen v shemi tik pred randomizacijo.
Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness.
Pri vsakem organskem sistemu so prednostni izrazi razvrščeni po padajoči pogostnosti in nato po padajoči resnosti.
Myelodysplastic syndrome/Acute myeloid leukaemia The overall incidence of myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) in patients treated in clinical trials with Lynparza monotherapy, including long-term survival follow-up, was <1.5% and the majority of events had a fatal outcome.
Mielodisplastični sindrom/akutna mieloična levkemija Celokupna pojavnost mielodisplastičnega sindroma/akutne mieloične levkemije (MDS/AML - myelodysplastic syndrome/acute myeloid leukaemia) je bila pri bolnicah, ki so v kliničnih preizkušanjih prejemale monoterapijo z zdravilom Lynparza, vključno v obdobju dolgoročnega spremljanja preživetja, < 1,5 % in večina teh primerov je bila s smrtnim izidom.
Olaparib does not affect the pharmacokinetics of tamoxifen.
Olaparib ne vpliva na farmakokinetiko tamoksifena.
No significant interaction was observed with anastrozole or letrozole, whereas tamoxifen decreased exposure to olaparib by 27%.
Z anastrozolom in letrozolom niso opazili pomembnega medsebojnega delovanja, tamoksifen pa je zmanjšal izpostavljenost olaparibu za 27 %.
A value <1 favours olaparib.
Vrednost < 1 je v korist olapariba.
Very common side effects that may show up in blood tests:
Zelo pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi:
In the olaparib-treated group, 28.4% of patients remained on treatment for ≥2 years and 14.9% for ≥5 years.
V skupini, zdravljeni z olaparibom, je 28,4 % bolnic ostalo na zdravljenju ≥ 2 leti in 14,9 % ≥ 5 let.
Lynparza has moderate influence on the ability to drive and use machines.
Zdravilo Lynparza ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Retrospective testing of patients with available tumour samples was performed using central testing and generated successful results in 341 patients, of which 95% had an eligible mutation (known [n=47] or likely pathogenic [n=277]) and 2 gBRCAwt patients were confirmed to have sBRCAm only.
Retrospektivno testiranje bolnic, za katere so bili na voljo vzorci tumorja, je bilo opravljeno s centralnim testiranjem in je dalo uspešne rezultate pri 341 bolnicah, od katerih jih je 95 % imelo ustrezno mutacijo (znano [n = 47] ali verjetno patogeno [n = 277]) in pri 2 gBRCAwt bolnicah je bilo potrjeno, da imata le sBRCAm.
Other medicines and Lynparza
Druga zdravila in zdravilo Lynparza
The capsules must be discarded after this period.
Po preteku tega obdobja je treba kapsule zavreči.
The European Medicines Agency has waived the obligation to submit the results of studies with Lynparza in all subsets of the paediatric population, in ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Lynparza za vse skupine pediatrične populacije pri karcinomu jajčnikov (izključujoč rabdomiosarkom in tumorje kličnih celic) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• ergot alkaloids - used to treat migraines and headaches
• ergot alkaloidi - uporabljajo se za zdravljenje migrene in glavobolov,
PFS2 (31% maturity)
PFS2 (31 % zrelost)
Vomiting events led to interruption in 10% of olaparib-treated patients; no olaparib-treated patients experienced a vomiting event leading to dose reduction.
Primeri bruhanja so vodili do prekinitve zdravljenja pri 10 % bolnic, zdravljenih z olaparibom; nobeni od bolnic, zdravljenih z olaparibom, se ni pojavilo bruhanje, ki bi vodilo do zmanjšanja odmerka.
Figure 7 PFS (BICR), Forest plot, by prespecified subgroup
PFS (BICR), drevesni diagram po vnaprej določenih podskupinah
• cisapride - used to treat stomach problems
• cisaprid - uporablja se za zdravljenje težav z želodcem,
Data demonstrating clinical validation of tumour BRCA1/2 tests in breast cancer are not currently available.
Podatkov, ki bi dokazovali klinično veljavnost testov mutacij BRCA1/2 v tumorju pri raku dojk, trenutno ni.
gBRCA1/2 mutation status should be determined by an experienced laboratory using a validated test method.
Prisotnost mutacije gBRCA1/2 mora ugotoviti izkušen laboratorij z validirano testno metodo.
Dose interruptions occurred most frequently in the first 3 months and dose reductions in the first 3-6 months of treatment.
Prekinitve uporabe so bili najpogostejši v prvih 3 mesecih zdravljenja in zmanjšanja odmerka so bili najpogostejši v prvih 3 - 6 mesecih zdravljenja.
Age - year (median)
Starost - leta (mediana)
Anaemia was managed with dose interruptions and dose reductions (see section 4.2), and where appropriate with blood transfusions.
Anemijo so obravnavali s prekinitvijo uporabe oz. zmanjšanji odmerka (glejte poglavje 4.2) ter s transfuzijami krvi, kjer je bilo to primerno.
Consequently, Lynparza may be taken without regard to food (see section 4.2).
Zato je mogoče zdravilo Lynparza jemati ne glede na hrano (glejte poglavje 4.2).
In patients with mutations (changes) in certain genes called BRCA (breast cancer gene), who are at risk of developing some forms of cancer, PARP inhibitors are able to trigger the death of cancer cells by blocking an enzyme that helps repair DNA.
Pri bolnicah z mutacijami (spremembami) posebnih genov, imenovanih "gen raka dojk" (BRCA), ki imajo veliko tveganje za pojav določenih oblik raka, lahko zaviralci PARP sprožijo odmrtje rakavih celic tako, da blokirajo encim, udeležen pri popravljanju DNK.
In BRCA-mutated patients (n=136) there was a statistically significant improvement in PFS, TFST and TSST.
Pri bolnicah z mutacijo gena BRCA (n = 136) so ugotovili statistično značilno izboljšanje PFS, TFST in TSST.
Frequency of CTCAE grade 3 and above
Pogostnost vseh stopenj po CTCAE Pogostnost stopenj 3 in več po CTCAE
By central germline testing, deleterious or suspected deleterious mutations were identified in 95.3% (365/383) and 4.7% (18/383) of patients, respectively.
S centralnim testiranjem germinalne linije so bile škodljive mutacije ugotovljene pri 95,3 % (365/383) in domnevno škodljive pri 4,7 % (18/383) bolnic.
They received an average of 3 previous chemotherapy regimens (range 2-11) and 2.6 previous platinum-containing chemotherapies (range 2-8).
Prejele so povprečno 3 predhodne sheme kemoterapije (razpon: od 2 do 11) in 2,6 predhodnih kemoterapij na osnovi platine (razpon: od 2 do 8).
Majority of the material was excreted as metabolites.
Večina materiala se je izločila v obliki presnovkov.
events/patients
dogodkov/bolnice
Patients were stratified based on: receipt of prior chemotherapy regimens for metastatic breast cancer (yes/no), hormone receptor (HR) positive vs triple negative (TNBC), prior platinum treatment for breast cancer (yes/no).
Bolnike so stratificirali glede na: prejemanje predhodnih shem kemoterapije za metastatskega raka dojk (da/ne), pozitivni hormonski receptorji (HR) v primerjavi s trojno negativnim rakom dojk (TNBC - triple negative breast cancer) ter predhodno zdravljenje s platino zaradi raka dojk (da/ne).
• a certain type of breast cancer (BRCA-mutated, HER2-negative) which has spread beyond the original tumour.
• določene vrste raka dojk (HER2-negativen rak dojk z mutacijo gena BRCA), ki se je razširil zunaj prvotnega tumorja.
• low white blood cell count (lymphopenia) which may decrease your ability to fight infection and may be associated with fever
• majhno število belih krvnih celic v krvi (limfocitopenija), zaradi česar se lahko zmanjša vaša sposobnost za premagovanje okužb in je lahko povezano z vročino,
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”.
Informacije o drugih sestavinah tega zdravila To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg ali 150 mg tableto, kar v bistvu pomeni ‘brez natrija'.
PFS - DCO 30 June 2010
PFS - DCO 30. junij 2010
Enrolment did not require evidence of BRCA1/2 mutation (BRCA mutation status for some patients was determined retrospectively).
Za vključitev ni bil potreben dokaz mutacije gena BRCA1/2 (stanje mutacije gena BRCA je bilo pri nekaterih bolnicah določeno retrospektivno).
What Lynparza is and what it is used for What you need to know before you take Lynparza How to take Lynparza
Kaj je zdravilo Lynparza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lynparza Kako jemati zdravilo Lynparza Možni neželeni učinki
Ovarian cancer Lynparza is indicated as monotherapy for the:
Rak jajčnikov Zdravilo Lynparza je indicirano kot monoterapija za:
Lynparza is supplied in packs containing 56 film-coated tablets (7 blisters of 8 tablets each), or multipacks containing 112 (2 packs of 56) film-coated tablets.
Zdravilo Lynparza je opremljeno v pakiranjih, ki vsebujejo 56 filmsko obloženih tablet (7 pretisnih omotov, od katerih vsak vsebuje 8 tablet), ali v skupnih pakiranjih, ki vsebuje 112 (2 pakiranji po 56) filmsko obloženih tablet.
The magnitude of the effect of moderate to strong inducers (e.g. efavirenz, rifabutin) on olaparib exposure is not established, therefore the co-administration of Lynparza with these medicinal products is also not recommended (see section 4.4).
Velikost učinka zmernih do močnih induktorjev (npr. efavirenza, rifabutina) na izpostavljenost olaparibu ni ugotovljena, zato sočasna uporaba zdravila Lynparza s takšnimi zdravili prav tako ni priporočljiva (glejte poglavje 4.4).
Your doctor has prescribed Lynparza capsules for you.
Zdravnik vam je predpisal kapsule zdravila Lynparza.
Olaparib inhibited UGT1A1 in vitro, however, PBPK simulations suggest this is not of clinical importance.
Olaparib je in vitro zaviral UGT1A1, toda PBPK-simulacije kažejo, da to ni klinično pomembno.
Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1).
Bolniki morajo biti predhodno zdravljeni z antraciklinom in taksanom v okviru (neo)adjuvantnega zdravljenja ali zdravljenja metastatske bolezni, razen če za ti zdravljenji niso primerni (glejte poglavje 5.1).
In Study 19, 20 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
V študiji 19 so pri 20 bolnicah ugotovili somatsko tumorsko mutacijo gena BRCA (mutacijo v tumorju, a divji tip v klični liniji).
Data from a double-blind placebo-controlled study showed median increase up to 23% from baseline remaining consistent over time and returning to baseline after treatment discontinuation, with no apparent clinical sequelae.
Podatki dvojno slepe, s placebom kontrolirane študije so pokazali mediano povečanje do 23 % v primerjavi z izhodiščem, konsistentno skozi čas in z vrnitvijo na izhodišče po prekinitvi zdravljenja, brez opaznih kliničnih posledic.
Lynparza is provided in HDPE plastic bottles containing 112 hard capsules.
Zdravilo Lynparza je na voljo v plastenkah iz HDPE, ki vsebujejo 112 trdih kapsul.
All patients
Vse bolnice
90% of patients had creatinine values of CTCAE grade 0 at baseline and 10% were CTCAE grade 1 at baseline.
90 % bolnic je imelo izhodiščno vrednosti kreatinina po CTCAE 0. stopnje in 10 % 1. stopnje.