FrancophonIA/ELRC3.0 huggingface dataset:
English: • digoxin, diltiazem, furosemide, verapamil, valsartan - used to treat heart conditions or high blood pressure
Danish: • digoxin, diltiazem, furosemid, verapamil, valsartan - anvendes til behandling af hjertelidelser eller forhøjet blodtryk
English: • You should have a pregnancy test before starting Lynparza, at regular times during treatment and 1 month after taking the last dose of Lynparza.
Danish: • Du skal tage en graviditetstest, inden du påbegynder behandling med Lynparza, regelmæssigt under behandlingen samt 1 måned efter du har taget din sidste dosis af Lynparza.
English: 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).
Danish: Alle patienter består af følgende subgrupper: BRCA1/2-muteret, BRCA1/2 wt/VUS og BRCA1/2-status ukendt (11 patienter med status ukendt, ikke vist som en separat undergruppe i tabellen).
English: 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.
Danish: Farmakokinetikken for olaparib ved en kapseldosis på 400 mg to gange dagligt er kendetegnet ved en tilsyneladende plasmaclearance på ~8,6 l/time, et tilsyneladende distributionsvolumen på ~167 l og en terminal halveringstid på 11,9 timer.
English: In BRCA1/2-deficient in vivo models, olaparib given after platinum treatment resulted in a delay in tumour progression and an increase in overall survival compared to platinum treatment alone that correlated with the period of olaparib maintenance treatment.
Danish: I BRCA1/2-defekte in vivo-modeller resulterede olaparib givet efter platinbehandling i en forsinkelse i tumorprogression og en stigning i samlet overlevelse i sammenligning med platinbehandling alene, hvilket korrelerede med perioden med vedligeholdelsesbehandling med olaparib.
English: Lynparza is a white, opaque, hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.
Danish: Lynparza er en hvid, uigennemsigtig hård kapsel mærket med “OLAPARIB 50 mg” og AstraZenecas logo med sort blæk.
English: 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.
Danish: Derfor bør der udvises forsigtighed, når sensitive CYP3A-substrater eller substrater med en snæver terapeutisk margin (fx simvastatin, cisaprid, ciclosporin, sekalealkaloider, fentanyl, pimozid, sirolimus, tacrolimus og quetiapin) kombineres med olaparib.
English: Maintenance treatment of platinum-sensitive relapsed (PSR) ovarian cancer SOLO2 Study
Danish: Vedligeholdelsesbehandling af platinsensitiv recidiverende (PSR) ovariecancer SOLO2-studiet
English: 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).
Danish: I førstelinjevedligeholdelsesbehandling af ovariecancer oplevede patienterne kvalme (77 % på olaparib, 38 % på placebo), opkastning (40 % på olaparib, 15 % på placebo), diarré (34 % på olaparib, 25 % på placebo) og dyspepsi (17 % på olaparib, 12 % på placebo).
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.
Danish: Subgruppeanalysen indikerede, at der var en fordel i PFS for olaparib versus komparator i TNBC (HR 0,43; 95 % CI: 0,29-0,63, n=152) og HR+ (HR 0,82; 95 % CI: 0,55-1,26, n=150) patientsubgrupperne.
English: In vitro, olaparib is a substrate of the efflux transporter P-gp, however, this is unlikely to be of clinical significance (see section 4.5).
Danish: In vitro er olaparib et substrat af efflukstransporteren P-gp, men det er usandsynligt, at det er af klinisk signifikans (se pkt.
English: In this study 302 patients with a documented deleterious or suspected deleterious gBRCA mutation were randomised 2:1 to receive either Lynparza (300 mg [2 x 150 mg tablets] twice daily) or physician's choice of chemotherapy (capecitabine 42%, eribulin 35%, or vinorelbine 17%) until progression or unacceptable toxicity.
Danish: I dette studie blev 302 patienter med en bekræftet risikogivende eller formodet risikogivende gBRCA-mutation randomiseret 2:1 til at få enten Lynparza (300 mg [2 x 150 mg tabletter] to gange dagligt) eller lægens valg af kemoterapi (capecitabin 42 %, eribulin 35 % eller vinorelbin 17 %) indtil progression eller uacceptabel toksicitet.
English: The majority of patients remained on the 400 mg bd starting dose of olaparib.
Danish: Størstedelen af patienterne forblev på startdosen 400 mg olaparib bd.
English: Other laboratory findings
Danish: Andre laboratoriefund
English: Male patients must use a condom during therapy and for 3 months after receiving the last dose of Lynparza when having sexual intercourse with a pregnant woman or with a woman of childbearing potential.
Danish: Mandlige patienter skal bruge kondom under behandlingen og i 3 måneder efter sidste dosis med Lynparza, når de har samleje med en gravid kvinde eller en kvinde i den fertile alder.
English: In the olaparib and placebo arms, 17% and 20% of patients had prior bevacizumab, respectively.
Danish: I olaparib- og placeboarmene havde henholdsvis 17 % og 20 % af patienterne tidligere modtaget bevacizumab.
English: The Grade ≥ 3 adverse reactions occurring in > 2% of patients were anaemia (16%), neutropenia (6%), fatigue/asthenia (6%), leukopenia (3%), thrombocytopenia (2%) and vomiting (2%).
Danish: Bivirkningerne af grad ≥ 3, der forekom hos > 2 % af patienterne var anæmi (16 %), neutropeni (6 %), træthed/asteni (6 %), leukopeni (3 %), trombocytopeni (2 %) og opkastning (2 %).
English: • herbal remedies containing St John's Wort (Hypericum perforatum) - used mainly for depression
Danish: • naturlægemidler, der indeholder perikon (Hypericum perforatum) - anvendes hovedsageligt mod depression
English: Embryofoetal toxicity
Danish: Embryoføtal toksicitet
English: Secondary efficacy endpoints included OS (overall survival), DCR (disease control rate) defined as confirmed CR/PR + SD (stable disease), HRQoL (health related quality of life), and disease related symptoms.
Danish: Sekundære virkningsendepunkter omfattede OS (samlet overlevelse), DCR (sygdomskontrolrate) defineret som bekræftet CR/PR + SD (stabil sygdom), HRQoL (helbredsrelateret livskvalitet) og sygdomsrelaterede symptomer.
English: The efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib (see sections 4.4 and 4.6).
Danish: Virkningen af nogle hormonelle antikonceptiva kan reduceres ved samtidig administration med olaparib (se punkt 4.4 og
English: Lynparza is not recommended for use in patients with severe hepatic impairment (Child-Pugh classification C), as safety and pharmacokinetics have not been studied in these patients.
Danish: Lynparza frarådes til patienter med svært nedsat leverfunktion (Child-Pugh klassifikation C), da sikkerhed og farmakokinetik ikke er undersøgt hos disse patienter.
English: • methotrexate - used to treat cancer, rheumatoid arthritis and psoriasis.
Danish: • methotrexat - anvendes til behandling af kræft, leddegigt og psoriasis.
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.
Danish: Patienter, som havde fået to eller flere platinholdige regimer og hvis sygdom var vendt tilbage > 6 måneder efter afslutning af den næstsidste platinbaserede kemoterapi, blev inkluderet.
English: • sore mouth (stomatitis).
Danish: • ømhed i munden (mundbetændelse).
English: Other medicines and Lynparza
Danish: Brug af anden medicin sammen med Lynparza
English: Multipack containing 112 (2 packs of 56) film-coated tablets.
Danish: Multipakning, der indeholder 112 (2 pakninger a 56) filmovertrukne tabletter.
English: There are no data in patients with severe impairment or end-stage renal disease (creatinine clearance <30 ml/min).
Danish: Der er ingen data for patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (kreatininclearance < 30 ml/min).
English: Genetic counselling for patients tested for mutations in BRCA1/2 genes should be performed according to local regulations.
Danish: Der skal gives genetisk rådgivning til patienter testet for mutationer i BRCA1/2-gener i henhold til lokale bestemmelser.
English: Missing dose If a patient misses a dose of Lynparza, they should take their next normal dose at its scheduled time.
Danish: Hvis en patient glemmer at tage en dosis Lynparza, skal næste normale dosis tages på det planlagte tidspunkt.
English: Platinum free interval was >12 months in 60% and >6-12 months in 40% of the patients.
Danish: Platinfrit interval var > 12 måneder hos 60 % og > 6-12 måneder hos 40 % af patienterne.
English: Dose adjustments for co-administration with CYP3A inhibitors Concomitant use of strong or moderate CYP3A inhibitors is not recommended and alternative agents should be considered.
Danish: Dosisjustering ved samtidig administration af CYP3A-inhibitorer Samtidig anvendelse af stærke eller moderate CYP3A-inhibitorer frarådes, og alternative midler bør overvejes.
English: In replicating cells this leads to DNA double strand breaks (DSBs) when replication forks meet the PARP-DNA adduct.
Danish: I replikerende celler fører dette til DNA-dobbeltstrengsbrud (DSB), når replikationsgafler møder PARP-DNA-adduktet.
English: • The usual recommended dose is 8 capsules (400 mg) taken by mouth twice a day (a total of 16 capsules each day).
Danish: • Den normale anbefalede dosis er 8 kapsler (400 mg), der tages gennem munden to gange dagligt (i alt 16 kapsler hver dag).
English: Platinum free interval was > 12 months in 60% and 6-12 months in 40% of the patients.
Danish: Platinfrit interval var > 12 måneder hos 60 % og 6-12 måneder hos 40 % af patienterne.
English: In Study 19, the incidence of anaemia was 22.8% (CTCAE grade ≥3 7.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 2.9%, 5.1% and 0%, respectively; 16.2% of patients treated with olaparib needed one or more blood transfusions during the treatment.
Danish: I Study 19 var forekomsten af anæmi 22,8% (CTCAE grad ≥3 7,4%), og forekomsten af dosisafbrydelser, reduktioner og afbrydelser på grund af anæmi var henholdsvis 2,9 %, 5,1 % og 0 %; 16,2 % af patienterne, som blev behandlet med olaparib, havde brug for en eller flere blodtransfusioner under behandlingen.
English: For patients with platinum sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, it is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.
Danish: Vedligeholdelsesbehandling af platinsensitiv recidiverende ovariecancer: Til patienter med platinsensitiv recidiverende high-grade epitelial ovarie-, tuba- eller primær peritonealcancer anbefales det, at behandlingen fortsættes, indtil progression af den underliggende sygdom eller uacceptabel toksicitet.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og flasken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: TFST (58% maturity) Number of events: Total number of patients (%)
Danish: TFST (58% modenhed) Antal hændelser: Samlet antal patienter
English: The majority of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers.
Danish: Størstedelen af rapporterne var om germline-mutationsbærere af brystcancerdisponeret gen 1 eller 2 (gBRCA1/2).
English: -----olaparib 400 mg bd twice daily, ____ placebo, x-axis=time from randomisation in months, yaxis=PFS (progression-free survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo
Danish: -----olaparib 400 mg bd to gange dagligt, ____ placebo, x-akse=tiden fra randomisering i måneder, yakse=PFS (progressionsfri overlevelse), n-olaparib= antal patienter i risiko -olaparib, n-placebo=antal patienter i risiko-placebo
English: Studies in animals have shown reproductive toxicity including serious teratogenic effects and effects on embryofoetal survival in the rat at maternal systemic exposures lower than those in humans at therapeutic doses (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet, herunder svære teratogene virkninger og virkninger på embryoføtal overlevelse hos rotter ved maternel systemisk eksponering, der er lavere end eksponeringen i mennesker ved terapeutiske doser (se pkt.
English: Ovarian cancer was the primary tumour in 86% of the patients.
Danish: Ovariecancer var den primære tumor hos 86 % af patienterne.
English: • fentanyl - used to treat cancer pain
Danish: • fentanyl - anvendes til behandling af smerter i forbindelse med kræft
English: Therefore, known strong inducers of this isozyme (e.g. phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarbital and St John's Wort) are not recommended with Lynparza, as it is possible that the efficacy of Lynparza could be substantially reduced.
Danish: Derfor frarådes administration af kendte stærke induktorer af dette isozym (fx phenytoin, rifampicin, rifapentin, carbamazepin, nevirapin, phenobarbital og perikon) sammen med Lynparza, da det er muligt, at effekten af Lynparza kan blive væsentligt nedsat.
English: In clinical studies with the tablet formulation, the incidence of anaemia adverse reactions was 38.8% (CTCAE grade ≥3 17.4%) and the incidences of dose interruptions, reductions and discontinuations for anaemia were 15.7%, 10.8% and 1.9%, respectively; 20.9% of patients treated with olaparib needed one or more blood transfusions.
Danish: I kliniske studier med tabletformuleringen var forekomsten af bivirkningen anæmi 38,8 % (CTCAE grad ≥3 17,4 %), og forekomsten af dosisafbrydelser, reduktioner og afbrydelser på grund af anæmi var henholdsvis 15,7 %, 10,8 % og 1,9 %; 20,9 % af patienterne, som blev behandlet med olaparib, havde brug for en eller flere blodtransfusioner.
English: 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%).
Danish: Et klinisk studie, der evaluerede påvirkningen fra rifampicin, en kendt CYP3A-induktor, viste, at administration sammen med olaparib reducerede den gennemsnitlige olaparib Cmax med 71 % (90 % CI: 76-67 %) og det gennemsnitlige AUC med 87 % (90 % CI: 89-84 %).
English: The safety and efficacy of olaparib in patients with gBRCA1/2-mutations who had HER2-negative metastatic breast cancer were studied in a Phase III randomised, open-label, controlled trial (OlympiAD).
Danish: Sikkerhed og virkning af olaparib hos patienter med gBRCA1/2-mutationer, der har HER2-negativ metastatisk brystcancer, blev undersøgt i et randomiseret, åben label, kontrolleret fase III-studie (OlympiAD).
English: Important differences in posology between Lynparza tablets and capsules Lynparza tablets (100 mg and 150 mg) should not be substituted for Lynparza capsules (50 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Danish: Vigtige forskelle i dosering mellem Lynparza tabletter og kapsler Lynparza tabletter (100 mg og 150 mg) må ikke erstattes af Lynparza kapsler (50 mg) på milligram til milligram basis på grund af forskelle i dosering og biotilgængelighed af de individuelle formuleringer.
English: This is because Lynparza can affect the way some other medicines work.
Danish: Det er fordi Lynparza kan påvirke den måde, hvorpå noget anden medicin virker, og noget anden medicin kan påvirke den måde, hvorpå Lynparza virker.
English: White, opaque, size 0 hard capsule, marked with “OLAPARIB 50 mg” and the AstraZeneca logo in black ink.
Danish: Hvid, uigennemsigtig, hård kapsel i størrelse 0, mærket med “OLAPARIB 50 mg” og AstraZenecas logo med sort blæk.
English: The analysis was performed using a Cox proportional hazards model with factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Danish: Analysen blev udført under anvendelse af en Cox-proportional hazards-model med faktorer for behandling, etnisk oprindelse, platinsensitivitet og respons på endelig platinbehandling.
English: What you need to know before you take Lynparza
Danish: Det skal du vide, før du begynder at tage Lynparza
English: Detection of BRCA1/2 mutations
Danish: Detektering af BRCA1/2-mutationer
English: -----olaparib 400 mg bd twice daily, ____placebo, x-axis=time from randomisation in months, yaxis=OS (overall survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo
Danish: -----olaparib 400 mg bd to gange dagligt, ____placebo, x-akse=tiden fra randomisering i måneder, y-akse=OS (samlet overlevelse), n-olaparib= antal patienter i risiko-olaparib, n-placebo=antal patienter i risiko-placebo
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.
Danish: Patienter med platinsensitiv recidiverende (PSR) high-grade epitelial ovarie-, tuba-, eller primær peritonealcancer, som reagerer (helt eller delvist) på platinbaseret kemoterapi, bør påbegynde behandling med Lynparza senest 8 uger efter afslutning af den sidste dosis af det platinholdige regime.
English: The primary endpoint was PFS assessed by blinded independent central review (BICR) using RECIST 1.1.
Danish: Det primære endepunkt var PFS vurderet ved blindet uafhængig central vurdering (BICR) ved anvendelse af RECIST 1.1.
English: • glibenclamide, metformin, repaglinide - used to treat diabetes
Danish: • glibenclamid, metformin, repaglinid - anvendes til behandling af sukkersyge
English: Mechanism of action and pharmacodynamic effects Olaparib is a potent inhibitor of human poly (ADP-ribose) polymerase enzymes (PARP-1, PARP-2, and PARP-3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo either as a standalone treatment or in combination with established chemotherapies.
Danish: Virkningsmekanisme og farmakodynamisk virkning Olaparib er en potent inhibitor af humane poly (ADP-ribose) polymeraseenzymer (PARP-1, PARP-2 og PARP-3) og har vist sig at hæmme væksten af udvalgte tumorcellelinjer in vitro og tumorvækst in vivo enten som monoterapi eller i kombination med etableret kemoterapi.
English: Very common Anaemia Common Neutropenia a, Thrombocytopenia a,
Danish: Meget almindelig Anæmi a, neutropeni a, trombocytopeni a,
English: • You must not donate sperm while taking Lynparza and for 3 months after taking the last dose.
Danish: • Du må ikke donere sæd, mens du tager Lynparza og i 3 måneder efter at have taget den sidste dosis.
English: Adverse reactions that most commonly led to permanent discontinuation were anaemia (1.3%), nausea (0.8%) and thrombocytopenia (0.5%).
Danish: De bivirkninger, der oftest medførte permanent seponering var anæmi (1,3 %), kvalme (0,8 %) og trombocytopeni
English: 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.
Danish: Analysen blev udført ved anvendelse af en Cox-proportional hazards-model, som inkluderede respons på tidligere platin-kemoterapi (CR eller PR) og tid til sygdomsprogression (> 6-12 måneder og > 12 måneder) i den næstsidste platinbaserede kemoterapi som kovariater.
English: Distribution The in vitro plasma protein binding is approximately 82% at 10 µg/mL which is approximately Cmax.
Danish: Fordeling In vitro-plasmaproteinbindingen er ca. 82 % ved 10 µg/ml, som er ca. Cmax.
English: Summary of key efficacy findings for patients with gBRCA1/2-mutated HER2negative metastatic breast cancer in OlympiAD
Danish: Sammenfatning af de vigtigste effektresultater for patienter med gBRCA1/2-muteret HER2-negativ metastatisk brystcancer i OlympiAD
English: Response to prior platinum chemotherapy was complete in 47% and partial in 53% of the patients.
Danish: Respons på tidligere platinkemoterapi var fuldstændigt hos 47 % og delvist hos 53 % af patienterne.
English: Demographic and baseline characteristics were generally well balanced between the olaparib and comparator arms (see Table 7).
Danish: Demografiske og baseline egenskaber var generelt velafbalancerede mellem olaparib- og komparatorarmene (se tabel 7).
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.
Danish: Patienter med CR defineret af investigatoren havde HR på 0,34 (95 % CI 0,24-0,47); median PFS ikke opnået for olaparib vs. 15,3 måneder for placebo.
English: Table 1 Tabulated list of adverse reactions
Danish: Tabel 1 Opstilling af bivirkninger i tabelform
English: The recommended dose of Lynparza is 400 mg (eight capsules) taken twice daily, equivalent to a total daily dose of 800 mg.
Danish: Den anbefalede dosis af Lynparza er 400 mg (otte kapsler), som tages to gange dagligt, svarende til en samlet daglig dosis på 800 mg.
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”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 100 mg eller 150 mg tablet, dvs. det er i det væsentlige natriumfrit.
English: Male patients should not donate sperm during therapy and for 3 months after receiving the last dose of Lynparza.
Danish: Mandlige patienter må ikke donere sæd under behandlingen og i 3 måneder efter sidste dosis med Lynparza.
English: 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).
Danish: In vitro hæmmer olaparib efflukstransportøren P-gp (IC50 = 76 µm), hvorfor det ikke kan udelukkes, at olaparib kan forårsage klinisk relevante lægemiddelinteraktioner med substrater for P-gp (fx simvastatin, pravastatin, dabigatran, digoxin og colchicin).
English: Contraception, pregnancy and breast-feeding
Danish: Antikonception, graviditet og amning
English: The study compared the efficacy of olaparib maintenance treatment taken until progression with no maintenance treatment in 265 (136 olaparib and 129 placebo) PSR serous ovarian cancer patients who were in response (CR [complete response] or PR [partial response]) confirmed as per RECIST and/or as per CA-125 criteria as defined by Gynecologic Cancer InterGroup (GCIG) (at least a 50% reduction in CA-125 levels from the last pre-treatment sample, confirmed 28 days later) following completion of two or more previous platinum-containing chemotherapy.
Danish: Studiet sammenlignede virkningen af olaparibvedligeholdelsesbehandling taget indtil progression med ingen vedligeholdelsesbehandling hos 265 (136 olaparib og 129 placebo) patienter med PSR serøs ovariecancer, som var i respons (CR [fuldstændig respons] eller PR [delvis respons]) bekræftet ifølge RECIST og/eller ifølge CA-125-kriterier som defineret af Gynecologic Cancer InterGroup (GCIG) (mindst en 50 % reduktion i CA-125-niveauerne i forhold til den sidste prøve taget inden behandling, bekræftet 28 dage senere) efter fuldførelse af to eller flere tidligere platinholdige kemoterapibehandlinger.