natgillin/translations-raw huggingface dataset:
PAES: For yderligere at definere virkningen af olaparib hos patienter med platinsensitiv recidiverende somatisk BRCA-muteret high-grade serøs ovariecancer, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af et åbent, enkeltarmet, ikke-randomiseret fase IV-multicenterstudie med patienter med recidiverende platinsensitiv ovariecancer med helt eller delvist respons efter platinbaseret kemoterapi og som har tab-af-funktion germline eller somatisk(e) BRCA-mutation(er).
PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed somatic BRCA mutated high grade serous ovarian cancer, the MAH should conduct and submit the results of a phase IV, open label, single arm, nonrandomised, multicentre study in patients with relapsed platinum sensitive ovarian cancer who are in complete or partial response following platinum based chemotherapy and who carry loss of function germline or somatic BRCA mutation(s).
Figur 3 SOLO2: Kaplan-Meier-plot af PFS hos patienter med gBRCA1/2m PSR-ovariecancer (63 % modenhed - investigatorvurdering)
Figure 3 SOLO2: Kaplan-Meier plot of PFS in patients with gBRCA1/2m PSR ovarian cancer (63% maturity - investigator assessment)
Det primære endepunkt var PFS (progressionsfri overlevelse) baseret på investigators vurdering under anvendelse af RECIST 1.0.
The primary endpoint was PFS (progression-free survival) based on investigator assessment using RECIST 1.0.
Det primære endepunkt var progressionsfri overlevelse (PFS) defineret som tid fra randomisering til progression bestemt efter investigators vurdering under anvendelse af modificeret Response
The primary endpoint was progression-free survival (PFS) defined as time from randomisation to progression determined by investigator assessment using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death.
En sammenfatning af de primære objektive resultater for patienter med BRCA1/2-muteret og BRCA1/2 wt/VUS PSR-ovariecancer i Study 19 er præsenteret i Tabel 4 og for alle patienter i Study 19 i Tabel 5 og Figur 4.
A summary of the primary objective outcome for patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19 is presented in Table 4 and for all patients in Study 19 in Table 5 and Figure 4.
Tidligere behandling med platin var tilladt i metastatisk regi under forudsætning af, at der ikke havde været tegn på sygdomsprogression under platinbehandlingen, og i (neo)adjuverende regi under forudsætning af, at den sidste dosis blev givet mindst 12 måneder før randomisering.
Proportion of patients alive progression during platinum treatment and in the (neo)adjuvant setting provided the last dose was received at least 12 months prior to randomisation.
P-værdi (2sidet)
P value (2-sided)
o Der bruges en test til at finde ud af, om du har BRCA-muteret brystkræft.
o A test is used to find out whether you have BRCA-mutated breast cancer.
HR (95% CI) P-værdi (2-sidet)
HR (95% CI) P value (2-sided)
Samtidig administration af Lynparza og stærke eller moderate CYP3A-induktorer frarådes.
Lynparza co-administration with strong or moderate CYP3A inducers is not recommended.
Kvinder i den fertile alder skal anvende to typer pålidelig antikonception før initiering af Lynparza-behandling, under behandling og i 1 måned efter at have fået den sidste dosis af Lynparza, medmindre afholdenhed er den valgte antikonceptionsmetode (se pkt.
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza therapy, during therapy and for 1 month after receiving the last dose of Lynparza, unless abstinence is the chosen method of contraception (see section 4.4).
I alt 18 (13,2 %) patienter modtog behandling i ≥ 5 år i olaparibgruppen sammenlignet med 1 (0,8 %) patient i placebogruppen.
A total of 18 (13.2%) patients received treatment for ≥5 years in the olaparib group compared with 1 (0.8%) patient in the placebo group.
Aktivt stof: olaparib
The active substance is olaparib.
Derfor er der ingen data om sikkerhed og virkning på olaparibpatienter, som tidligere havde fået bevacizumab.
Patients who had been treated with bevacizumab were excluded from the study, therefore there are no safety and efficacy data on olaparib patients who had previously received bevacizumab.
Du vil blive bedt om at tage 6 kapsler (300 mg) to gange dagligt
You will be asked to take 6 capsules (300 mg) twice a day - a total of 12 capsules each day.
Race (%)
Race (%) White Asian Other
Sådan skal du tage Lynparza
How to take Lynparza
Patienter med BRCA1/2-mutationer blev identificeret enten ved germline-test i blod via en lokal test eller med central test hos Myriad eller ved at teste en tumorprøve ved en lokal test udført af Foundation Medicine.
Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a test performed by Foundation Medicine.
Et sammendrag af de vigtigste sekundære objektive resultater for patienter med BRCA1/2-muteret og BRCA1/2 wt/VUS PSR ovariecancer i Study 19 er vist i Tabel 6 og for alle patienter i Study 19 i Tabel 6 og Figur 5.
A summary of key secondary objective outcomes for patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19 is presented in Table 6 and for all patients in Study 19 in Table 6 and Figure 5.
Figur 2 SOLO1: Kaplan-Meier-plot over OS hos nyligt diagnosticerede patienter med fremskreden BRCA1/2m-ovariecancer (21 % modenhed)
Figure 2 SOLO1: Kaplan-Meier plot of OS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (21% maturity)
Tabel 4 Sammendrag af centrale sekundære objektive resultater for patienter med gBRCA1/2m PSR ovariecancer i SOLO2
Table 4 Summary of key secondary objective outcomes for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Demografiske og baseline karakteristika var generelt velbalanceret mellem olaparib- og placebobehandlingsarmene.
Demographic and baseline characteristics were generally well balanced between the olaparib and placebo treatment arms.
Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager noget af ovenstående, eller hvis du tager anden medicin.
Tell your doctor, pharmacist or nurse if you are taking any of the above or any other medicines.
Tabel 6 Sammendrag af vigtigste sekundære objektive resultater for alle patienter og patienter med BRCA1/2 muteret og BRCA1/2 wt/VUS PSR ovariecancer i Study 19
Table 6 Summary of key secondary objective outcomes for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Demografiske og baseline egenskaber var generelt godt afbalanceret mellem olaparib- og placeboarmene.
Demographic and baseline characteristics were generally well balanced between the olaparib and placebo arms.
PAES: For yderligere at bekræfte effektiviteten af olaparib som vedligeholdelsesbehandling efter platinholdig førstelinjekemoterapi til patienter med BRCA-muteret high-grade serøs ovariecancer, skal indehaveren af markedsføringstilladelsen indsende den opdaterede PFS2, opdaterede OS og endelige OS-resultater fra studiet D0818C00001 (SOLO1), et randomiseret, dobbeltblindet, placebokontrolleret, fase III-, multicenterstudie.
PAES: In order to further confirm the efficacy of olaparib as maintenance treatment after the first-line platinum-containing chemotherapy in patients with BRCA mutated high grade serous ovarian cancer, the MAH should submit the updated PFS2, updated OS and final OS results of the study D0818C00001 (SOLO1), a phase III randomised double-blind placebo-controlled multicentre study.
PAES: For yderligere at definere effektiviteten af olaparib som vedligeholdelsesbehandling af patienter med platinfølsom, tilbagevendende (PSR) ikke-germline BRCA muteret high-grade ovariecancer og undersøge prædiktive biomarkører inden for denne patientgruppe, skal indehaveren af markedsføringstilladelsen indsende resultaterne af undersøgelsen D0816C00020 (OPINION), et enkeltarmet, åbent fase IIIb-multicenterstudie af vedligeholdelsesbehandling hos PSR ikke-germline BRCA-muterede ovariecancerpatienter, som er i helt eller delvis respons efter platinbaseret kemoterapi.
PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed (PSR) non-germline BRCA mutated high grade ovarian cancer in the maintenance setting and investigate predictive biomarkers within this patient group, the MAH should submit the results of study D0816C00020 (OPINION), a phase IIIb single-arm, open-label, multicentre study of maintenance therapy in PSR non-germline BRCA mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
• bosentan - anvendes til behandling af forhøjet blodtryk i lungerne
• bosentan - used to treat pulmonary artery hypertension
Figur 1 SOLO1: Kaplan-Meier-plot af PFS hos nyligt diagnosticerede patienter med fremskreden BRCA1/2m-ovariecancer (51 % modenhed - investigatorvurdering)
Figure 1 SOLO1: Kaplan-Meier plot of PFS in newly diagnosed patients with BRCA1/2m advanced ovarian cancer (51% maturity - investigator assessment)
Median, måneder (95% CI)
Median, months (95% CI)
Hver filmovertrukket tablet indeholder 100 mg olaparib.
Each film-coated tablet contains 100 mg of olaparib.
Kvinder i den fertile alder skal anvende to typer pålidelig antikonception før initiering af Lynparza-behandling, under behandlingen og i 1 måned efter sidste dosis med Lynparza.
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 1 month after receiving the last dose of Lynparza.
Hvis der er brug for endnu en dosisreduktion, så anbefales en reduktion til 200 mg (to 100 mg tabletter) to gange dagligt (svarende til en samlet daglig dosis på 400 mg).
If a further dose reduction is required, then reduction to 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) is recommended.
MedDRAsystemorganklas se
MedDRA System Organ Class
4.2) og, når det var nødvendigt, med blodtransfusioner.
Anaemia was managed with dose interruptions and dose reductions (see section 4.2), and where appropriate with blood transfusions.
Det anbefales, at Lynparza-dosis reduceres til 100 mg to gange dagligt (svarende til en samlet daglig dosis på 200 mg) sammen med en stærk CYP3A-inhibitor eller 150 mg to gange dagligt (svarende til en samlet daglig dosis på 300 mg) sammen med en moderat CYP3A-inhibitor (se pkt.
The recommended Lynparza dose reduction is to 100 mg taken twice daily (equivalent to a total daily dose of 200 mg) with a strong CYP3A inhibitor or 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Virkningen af nogle hormonelle antikonceptiva kan reduceres ved samtidig administration med olaparib (se også pkt.
The efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib (see also sections 4.4 and 4.6).
Ved den endelige OS-analyse (skæringsdato for data (DCO) 9. maj 2016) ved 79 % modenhed var hazard ratio ved sammenligning af olaparib med placebo 0,73 (95 % CI 0,55-0,95; p=0,02138 (opnåede ikke det præspecificerede signifikansniveau på < 0,0095); median 29,8 måneder for olaparib versus 27,8 måneder for placebo).
At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the hazard ratio comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
Tabel 5 Sammenfatning af de primære objektive resultater for alle patienter og patienter med BRCA1/2-muteret og BRCA1/2 wt/VUS PSR-ovariecancer i SStudy 19
Table 5 Summary of primary objective outcome for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
PAES: For yderligere at bekræfte virkningen af olaparib hos patienter med platinsensitiv recidiverende BRCA-muteret high-grade serøs ovariecancer, skal indehaveren af markedsføringstilladelsen indsende resultaterne af studie D0816C00002, et randomiseret, dobbeltblindet, placebokontrolleret, fase III-multicenterstudie.
PAES: In order to further confirm the efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the results of study D0816C00002, a phase III randomised double-blind placebo-controlled multicentre study.
Antikonception hos mænd
Contraception in males
I olaparib-armen havde 55 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 45 % havde modtaget 3 eller flere tidligere behandlingslinjer.
In the olaparib arm 55% of the patients had only 2 prior lines of treatment with 45% receiving 3 or more prior lines of treatment.
Ved den sidste OS-analyse (skæringsdato for data (DCO) 9. maj 2016) ved 79 % modenhed var HR ved sammenligning af olaparib og placebo 0,73 (95 % CI 0,55-0,95; p=0,02138 (opnåede ikke det præspecificerede signifikansniveau på < 0,0095); median 29,8 måneder for olaparib versus 27,8 måneder for placebo).
At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the HR comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
De fleste patienter havde en ECOG performance status på 0 (81 %); der er ingen data for patienter med funktionsstatus 2 til 4.
Most patients were ECOG performance status 0 (81%), there are no data in patients with performance status 2 to 4.
Figur 1 Study 19: Kaplan-Meier-plot af PFS for BRCA-muterede patienter (53 % modenhedinvestigators vurdering)
Figure 1 Study 19: Kaplan-Meier plot of PFS in BRCA-mutated patients (53% maturity-investigator assessment)
Mediantid (måneder) (95 % CI) HR (95% CI)
Median time (months) (95% CI) HR (95% CI)
Det anbefales, at Lynparza-dosis reduceres til 150 mg to gange dagligt (svarende til en samlet daglig dosis på 300 mg) sammen med en potent CYP3A-inhibitor og til 200 mg to gange dagligt (svarende til en samlet daglig dosis på 400 mg) sammen med en moderat CYP3A-inhibitor (se pkt.
The recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a strong CYP3A inhibitor or 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
I placebo-armen havde 61 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 39 % havde modtaget 3 eller flere tidligere behandlingslinjer.
In the placebo arm 61% of patients had received only 2 prior lines with 39% receiving 3 or more prior lines of treatment.
Placebo Olaparib 400 mg kapsel bd
Placebo Olaparib 400 mg capsule bd
Hvis der er brug for endnu en dosisreduktion, så anbefales en reduktion til 100 mg to gange dagligt (svarende til en samlet daglig dosis på 200 mg).
If a further dose reduction is required, then reduction to 100 mg twice daily (equivalent to a total daily dose of 200 mg) is recommended.
Det primære endepunkt var PFS baseret på investigatorvurdering under anvendelse af RECIST 1.0.
The primary endpoint was PFS based on investigator assessment using RECIST 1.0.
Tabletkerne Copovidon
Film-coated tablets
bd To gange dagligt; CI konfidensinterval; DOR Varighed af respons, DCO data cut off; HR hazard ratio; HR+ hormonreceptor positiv, ORR objektiv responsrate; OS samlet overlevelse; PFS progressionfri overlevelse; PFS2 Tid til anden progression eller død, TNBC tripel negativ brystcancer.
In the HR+ patient subgroup the confirmed ORR was 57% (46/81) in the olaparib arm and 33% (11/33) in the comparator arm. bd Twice daily; CI Confidence interval; DOR Duration of response; DCO Data cut off; HR Hazard ratio; HR+ Hormone receptor positive, ORR Objective response rate; OS overall survival; PFS progression-free survival; PFS2 Time to second progression or death, TNBC triple negative breast cancer.
Sikkerhed og effekt af olaparib som vedligeholdelsesbehandling i behandlingen af patienter med PSR ovariecancer, herunder patienter med tubacancer eller med primær peritoneal cancer, efter behandling med to eller flere platinholdige regimer, blev undersøgt i et stort randomiseret, dobbeltblindet, placebokontrolleret fase II-studie (SStudy 19).
The safety and efficacy of olaparib as a maintenance therapy in the treatment of PSR ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a large Phase II randomised, double-blind, placebo-controlled trial (Study 19).
• Hver Lynparza 150 mg filmovertrukket tablet indeholder 150 mg olaparib.
• Each Lynparza 150 mg film-coated tablet contains 150 mg olaparib.
Bekræftet ORR - DCO 9. december
Confirmed ORR - DCO 09 December 2016
En planlagt sub-gruppeanalyse identificerede patienter med BRCA1/2-muteret ovariecancer (n=136, 51,3 %; heraf 20 patienter, som havde en somatisk tumor-BRCA1/2-mutation) som den sub-gruppe, der opnåede den største kliniske fordel af vedligeholdelsesbehandling med olaparib monoterapi.
51.3%; including 20 patients identified with a somatic tumour BRCA1/2 mutation) as the subgroup that derived the greatest clinical benefit from olaparib maintenance monotherapy.
• colchicin - anvendes til behandling af urinsyregigt
• colchicine - used to treat gout
PFS2 (31 % modenhed) Antal hændelser: Samlet antal patienter (%) Mediantid (måneder)
PFS2 (40% maturity) Number of events: Total number of patients (%)
I olaparib-armen havde 44 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 56 % havde modtaget 3 eller flere tidligere behandlingslinjer.
In the olaparib arm 44% of the patients had only 2 prior lines of treatment with 56% receiving 3 or more prior lines of treatment.
Grøn til grågrøn, oval, bikonveks tablet, præget med "OP150" på den ene side og ingenting på den anden side.
Green to green/grey, oval, bi-convex tablet, debossed with ‘OP150' on one side and plain on the other side.
I placebo-armen havde 49 % af patienterne kun modtaget 2 tidligere behandlingslinjer, mens 51 % havde modtaget 3 eller flere tidligere behandlingslinjer.
In the placebo arm 49% of patients had received only 2 prior lines with 51% receiving 3 or more prior lines of treatment.
Gul til mørkegul, oval, bikonveks tablet, præget med "OP100" på den ene side og ingenting på den anden side.
Yellow to dark yellow, oval, bi-convex tablet, debossed with ‘OP100' on one side and plain on the other side.
• Hver Lynparza 100 mg filmovertrukket tablet indeholder 100 mg olaparib.
• Each Lynparza 100 mg film-coated tablet contains 100 mg olaparib.
De fleste patienter havde en ECOG performance status på 0 (77 %); der er ingen data for patienter med performance status 2 til 4.
Most patients were ECOG performance status 0 (77%), there are no data in patients with performance status 2 to 4.
Lynparza 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg olaparib.
Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib.
De fleste patienter havde en ECOG performance status på 0 (78 %); der er ingen data for patienter med performance status på 2 til 4.
Most patients were ECOG performance status 0 (78%), there are no data in patients with performance status 2 to 4.
Olaparib 400 mg kapsel bd
Olaparib 400 mg capsule bd
Studiet opfyldte sit primære mål og demonstrerede en statistisk signifikant forbedring i investigatorvurderet PFS for olaparib sammenlignet med placebo med en HR på 0,30 (95 % CI 0,220,41; p<0,0001; median 19,1 måneder for olaparib vs 5,5 måneder for placebo).
The study met its primary objective demonstrating a statistically significant improvement in investigator assessed PFS for olaparib compared with placebo with a HR of 0.30 (95% CI 0.22-0.41; p<0.0001; median 19.1 months olaparib vs 5.5 months placebo).
Den anbefalede dosis af Lynparza til patienter med moderat nedsat nyrefunktion (kreatininclearance 31 til 50 ml/min) er 200 mg (to 100 mg tabletter) to gange dagligt (svarende til en samlet daglig dosis på 400 mg) (se pkt.
For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) (see section 5.2).
Sikkerhed og virkning af olaparib som vedligeholdelsesterapi i behandlingen af patienter med platinsensitiv recidiverende (PSR) high-grade serøs ovarie-, tuba- eller primær peritoneal cancer efter behandling med to eller flere platinholdige regimer blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret fase II-studie (Study 19).
The safety and efficacy of olaparib as a maintenance therapy in the treatment of platinum-sensitive relapsed (PSR) high grade serous ovarian, including fallopian tube or primary peritoneal cancer patients, following treatment with two or more platinum-containing regimens, were studied in a Phase II randomised, double-blind, placebo-controlled trial (study 19).
Disse specifikke kræftceller kan identificeres ved: at de reagerer på platinbaseret kemoterapi, eller at de har beskadigede DNA-reparationsgener, såsom BRCA-gener (brystcancergener).
• looking for faulty DNA repair genes, such as BRCA (BReast CAncer) genes.
Hver filmovertrukket tablet indeholder 150 mg olaparib.
Each film-coated tablet contains 150 mg of olaparib.
Samtidig administration af Lynparza og stærke eller moderate CYP3A-inhibitorer frarådes (se pkt.
Lynparza co-administration with strong or moderate CYP3A inhibitors is not recommended (see section 4.5).
Dosisjustering af Lynparza er ikke nødvendig til patienter med let eller moderat nedsat leverfunktion (se pkt.
No Lynparza dose adjustment is required for patients with mild or moderate hepatic impairment (see section 4.2).
Det primære endepunkt var PFS baseret på investigators vurdering under anvendelse af RECIST 1.1.
The primary endpoint was PFS determined by investigator assessment using RECIST 1.1.
Lynparza 100 mg tabletter olaparib
Lynparza 100 mg tablets olaparib
Den anbefalede dosis af Lynparza til patienter med moderat nedsat nyrefunktion (kreatininclearance 31 til 50 ml/min) er 300 mg to gange dagligt (svarende til en samlet daglig dosis på 600 mg) (se pkt.
For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 300 mg twice daily (equivalent to a total daily dose of 600 mg) (see section 5.2).
Lynparza 150 mg tabletter olaparib
Lynparza 150 mg tablets olaparib
Studiet opfyldte sit primære mål og demonstrerede en statistisk signifikant forbedring af PFS for olaparib sammenlignet med placebo i den samlede population med en hazard ratio (HR) på 0,35 (95 % CI 0,25-0,49; p<0,00001; median 8,4 måneder for olaparib versus 4.8 måneder for placebo).
The study met its primary objective demonstrating a statistically significant improvement in PFS for olaparib compared with placebo in the overall population with a hazard ratio (HR) of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib versus 4.8 months placebo).
Det er vist, at olaparib hæmmer BCPR, OATP1B1, OCT1, OCT2, OAT3, MATE1 og MATE2K in vitro.
In vitro, olaparib has been shown to be an inhibitor of BCRP, OATP1B1, OCT1, OCT2, OAT3, MATE1 and MATE2K.
Lynparza 150 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg olaparib.
Lynparza 150 mg film-coated tablets Each film-coated tablet contains 150 mg olaparib.
Studiet opfyldte sit primære mål og påviste en statistisk signifikant forbedring af PFS for olaparib i sammenligning med placebo i den samlede population med en HR på 0,35 (95 % CI 0,25-0,49; p<0,00001; median 8,4 måneder for olaparib vs 4,8 måneder for placebo).
The study met its primary objective demonstrating a statistically significant improvement in PFS for olaparib compared with placebo in the overall population with a HR of 0.35 (95% CI 0.25-0.49; p<0.00001; median 8.4 months olaparib vs 4.8 months placebo).