natgillin/translations-raw huggingface dataset:
N Antal af hændelser/antal af randomiserede patienter; bd To gange dagligt; OS samlet overlevelse; PFS progressionsfri overlevelse; CI konfidensinterval; DCO Skæringsdato for data; TSST Tid fra randomisering til start af anden efterfølgende behandling eller død. 
N Number of events/number of randomised patients; bd Twice daily; OS Overall survival; PFS Progression-free survival; CI Confidence interval; DCO Data cut off; TSST Time from randomisation to start of second subsequent therapy or death.
Toksicitet efter gentagne doser 
Repeat-dose toxicity
Selvom antallet af patienter var begrænset, forblev 13,2 % (n=18/136) af patienterne i den olaparibbehandlede gruppe på behandlingen i ≥ 5 år sammenlignet med 0,8 % (n=1/128) i placebogruppen. 
Although patient numbers were limited, 13.2% (n=18/136) of the patients in the olaparib-treated group remained on treatment for ≥5 years as compared with 0.8% (n=1/128) in the placebo group.
BRCA1/2-muteret 
BRCA1/2-mutated
Figur 2 Study 19: Kaplan-Meier-plot af OS hos BRCA-muterede patienter (73 % modenhed) 
Figure 2 Study 19: Kaplan-Meier plot of OS in BRCA-mutated patients (73% maturity)
Studiet sammenlignede virkningen af vedligeholdelsesbehandling med Lynparza [300 mg (2 x 150 mg tabletter) to gange daglig], som blev taget indtil progression med virkningen af placebobehandling hos 295 patienter med high-grade serøs eller endometrioid PSR-ovariecancer (2:1 randomisering: 196 olaparib og 99 placebo), som opnåede respons (CR eller PR) efter afslutning af platinholdig kemoterapi. 
The study compared the efficacy of Lynparza maintenance treatment (300 mg [2 x 150 mg tablets] twice daily) taken until progression with placebo treatment in 295 patients with high-grade serous or endometrioid PSR ovarian cancer (2:1 randomisation: 196 olaparib and 99 placebo) who were in response (CR or PR) following completion of platinum-containing chemotherapy.
In vitro-data viser også, at olaparib ikke er et substrat for OATP1B1, OATP1B3, OCT1, BCRP eller MRP2 og ikke er en inhibitor for OATP1B3, OAT1 eller MRP2. 
In vitro, data also show that olaparib is not a substrate for OATP1B1, OATP1B3, OCT1, BCRP or MRP2 and is not an inhibitor of OATP1B3, OAT1 or MRP2.
TFST - DCO 09 maj 2016 
TFST - DCO 09 May 2016
P-værdi (2-sidet) 
p-value (2-sided)
Lynparza fås som 100 mg og 150 mg tabletter. 
Lynparza is available as 100 mg and 150 mg tablets.
Lynparza 150 mg tabletter er grønne til grågrønne, ovale, bikonvekse filmovertrukne tabletter markeret med "OP150" på den ene side og ingenting på den anden side. 
Lynparza 150 mg tablets are green to green/grey, oval, bi-convex, film-coated tablets, marked with “OP150” on one side and plain on the other.
Tabel 2 Sammenfatning af nøglefund for virkning for patienter med BRCA-muteret PSR-ovariecancer i Study 19 
Table 2 Summary of key efficacy findings for patients with BRCA-mutated PSR ovarian cancer in Study 19
I den olaparibbehandlede gruppe forblev 23,5 % (n=32/136) af patienterne på behandlingen i ≥ 2 år sammenlignet med 3,9 % (n=5/128) af patienterne på placebo. 
In the olaparib-treated group, 23.5% (n=32/136) of patients remained on treatment for ≥2 years as compared with 3.9% (n=5/128) of the patients on placebo.
• Kapselskal: hypromellose, titandioxid (E171), gellangummi (E418), kaliumacetat. 
• Capsule shell: hypromellose, titanium dioxide (E171), gellan gum (E418), potassium acetate.
bd To gange dagligt; DCO Skæringsdato for data; FAS Fuldt analysesæt; OS Samlet overlevelse 
bd Twice daily; DCO Data cut off; FAS Full analysis set; OS Overall survival
Almindelig Træthed (inklusive asteni) 
Common Fatigue (including asthenia)
Lynparza er indiceret som monoterapi til vedligeholdelsesbehandling af voksne patienter med platinsensitiv recidiverende BRCA-muteret (germline og/eller somatisk) high-grade serøs epitelial ovarie-, tuba- eller primær peritonealcancer, som responderer (fuldstændigt eller delvist) på platinbaseret kemoterapi. 
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Lynparza 100 mg tabletter er gule til mørkegule, ovale, bikonvekse filmovertrukne tabletter markeret med "OP100" på den ene side og ingenting på den anden side. 
Lynparza 100 mg tablets are yellow to dark yellow, oval, bi-convex, film-coated tablets, marked with “OP100” on one side and plain on the other.
I kliniske studier med Lynparza var forekomsten af skift i CTCAE grad ≥2 (fald) fra baseline i hæmoglobin 20 %, absolutte neutrofiler 20 %, trombocytter 5 %, lymfocytter 30 % og leukocytter 20 % (alle % omtrentlige). 
In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (decreases) from baseline in haemoglobin was 20%, absolute neutrophils 20%, platelets 5%, lymphocytes 30% and leucocytes 20% (all % approximate).
Den anbefalede dosisreduktion er til 200 mg to gange dagligt (svarende til en samlet daglig dosis på 400 mg). 
The recommended dose reduction is to 200 mg twice daily (equivalent to a total daily dose of 400 mg).
bd To gange dagligt; NR Ikke nået; CI Konfidensinterval; PFS Progressionsfri overlevelse; PFS2 Tid til anden progression eller død; OS Samlet overlevelse; TFST Tid fra randomisering til første efterfølgende anticancerbehandling eller død. 
bd Twice daily; NR Not reached; CI Confidence interval; PFS Progression-free survival; PFS2 Time to second progression or death; OS Overall survival; TFST Time from randomisation to first subsequent anti-cancer therapy or death.
Mandlige patienter og deres kvindelige partnere i den fertile alder skal anvende sikker antikonception under behandlingen og i 3 måneder efter sidste dosis med Lynparza (se pkt. 
Male patients and their female partners of childbearing potential should use reliable contraception during therapy and for 3 months after receiving the last dose of Lynparza (see section 4.6).
Anæmi omfatter de foretrukne termer for anæmi, makrocytisk anæmi, erytropeni, nedsat hæmatokrit, nedsat hæmoglobin, normokrom anæmi, normokrom normocytisk anæmi, normocytisk anæmi og nedsat antal røde blodlegemer; Neutropeni omfatter de foretrukne termer for agranulocytose, febril neutropeni, nedsat granulocyttal, granulocytopeni, idiopatisk neutropeni, neutropeni, neutropenisk infektion, neutropenisk sepsis og nedsat neutrofiltal; Trombocytopeni omfatter de foretrukne termer for nedsat antal trombocytter, nedsat trombocytproduktion, nedsat hæmatokrit og trombocytopeni; Leukopeni omfatter de foretrukne termer for leukopeni og nedsat antal hvide blodlegemer; Lymfopeni omfatter de foretrukne termer for nedsat antal B-lymfocytter, nedsat antal lymfocytter, lymfopeni og nedsat antal T-lymfocytter; Hoste omfatter de foretrukne termer for hoste og produktiv hoste; Udslæt omfatter de foretrukne termer for eksfoliativt udslæt, generaliseret erytem, udslæt, erytematøst udslæt, generaliseret udslæt, makulært udslæt, makulo-papuløst udslæt, papuløst udslæt og kløende udslæt; Hypersensitivitet omfatter de foretrukne termer for lægemiddelhypersensitivitet og hypersensitivitet; Dermatitis omfatter de foretrukne termer for dermatitis, allergisk dermatitis og eksfoliativ dermatitis. 
Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decreased and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased; Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
bd To gange dagligt; OS Samlet overlevelse; DCO data cut off; CI konfidensinterval; TFST tid fra randomisering til start af første efterfølgende behandling eller død. 
bd Twice daily; OS Overall survival; DCO data cut off; CI confidence interval; TFST time from randomisation to start of first subsequent therapy or death.
Derfor frarådes det at anvende kendte stærke inhibitorer (fx itraconazol, telithromycin, clarithromycin, proteaseinhibitorer boostet med ritonavir eller cobicistat, boceprevir, telaprevir) eller moderate inhibitorer (fx erythromycin, diltiazem, fluconazol, verapamil) af dette isozym sammen med Lynparza (se pkt. 
Therefore, known strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir) or moderate (e.g. erythromycin, diltiazem, fluconazole, verapamil) inhibitors of this isozyme are not recommended with Lynparza (see section 4.4).
Tabel 2 Effektresultater for nyligt diagnosticerede patienter med fremskreden BRCA1/2m-ovariecancer i SOLO1 
Table 2 Efficacy results for newly diagnosed patients with BRCA1/2m advanced ovarian cancer in SOLO1
Baselinetest, efterfulgt af månedlig monitorering, af komplet blodtælling anbefales i de første 12 måneders behandling og regelmæssigt derefter for at monitorere, om der sker klinisk signifikante ændringer i en eller flere parametre under behandlingen (se pkt. 
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).
• vedligeholdelsesbehandling af voksne patienter med platinsensitiv recidiverende high-grade epitelial ovarie-, tuba- eller primær peritonealcancer, som responderer (fuldstændigt eller delvist) på platinbaseret kemoterapi. 
• maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Sikkerhed og virkning af olaparib som vedligeholdelsesbehandling blev undersøgt hos patienter med nyligt diagnosticeret fremskreden (FIGO stadie III-IV) high-grade serøs eller endometrioid BRCA1/2-muteret (BRCA1/2m) ovariecancer efter fuldførelse af platinbaseret førstelinjekemoterapi i et randomiseret, dobbeltblindet, placebokontrolleret, fase III-, multicenterstudie. 
The safety and efficacy of olaparib as maintenance therapy were studied in patients with newly diagnosed advanced (FIGO Stage III-IV) high-grade serous or endometrioid BRCA1/2 mutated (BRCA1/2m) ovarian cancer following completion of first-line platinum-based chemotherapy in a Phase III randomised, double-blind, placebo-controlled, multicentre trial.
Lynparza 50 mg hårde kapsler olaparib 
Lynparza 50 mg hard capsules olaparib
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