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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001211-75 | EudraCT Number |
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| Name | Class |
|---|---|
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
| Myriad Genetic Laboratories, Inc. | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.
Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib 300mg tablets | Experimental | Taken orally twice daily |
|
| Placebo tablets | Placebo Comparator | Taken orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib 300mg tablets | Drug | 300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) | To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. | Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS). | Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
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Inclusion Criteria:
Patients must be ≥ 18 years of age.
For the penultimate chemotherapy course prior to enrolment on the study:
• Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy
For the last chemotherapy course immediately prior to randomisation on the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor E Pujade-Lauraine, MD, PhD | Universite de Paris Descartes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Palo Alto Foundation Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41861615 | Derived | Ledermann JA, Lortholary A, Penson RT, Asher R, Gebski V, Provencher D, Bruchim I, Huzarski T, Barretina-Ginesta MP, Pipitone S, Mileshkin L, Colombo N, Park-Simon TW, Matsumoto K, Boere I, Mikheeva O, Kim JW, Girotto G, Vergote I, Carter D, Lowe ES, Pujade-Lauraine E. Adverse event profile following maintenance olaparib in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer in the phase III SOLO2 trial. Int J Gynecol Cancer. 2026 May;36(5):104556. doi: 10.1016/j.ijgc.2026.104556. Epub 2026 Mar 2. | |
| 39695768 |
| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
It was planned that approximately 264 women from the Global Cohort and 33 women from the China Cohort, with BRCA mutated relapsed ovarian cancer who are in complete or partial response following platinum based chemotherapy, were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.
Global Cohort: First patient screened: 03 Sep 2013; last patient screened on 21 Nov 2014. 602 patients screened across 119 centres in 16 countries; 295 were randomized. Results are reported for analysis of PFS (DCO: 19 Sep 2016) and OS (DCO: 03 Feb 2020).
China Cohort: First patient enrolled: 07 Apr 2015; last patient enrolled: 30 Oct 2015. 127 patients screened across 16 sites; 32 were randomized. Results are reported for analysis of PFS (DCO: 16 Jan 2017) and OS (DCO: 03 Feb 2020).
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| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib 300mg Tablets (Global Cohort) | Taken orally twice daily |
| FG001 | Placebo Tablets (Global Cohort) | Taken orally twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo to match olaparib 300mg | Drug | 300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity. |
|
| Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death. | CA-125 at baseline then every 4 wks. Radiologic scans at baseline then every ~12 wks up to 72 wks, then every ~ 24 wks until objective radiological disease progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths. |
| Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression | Scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. Assessments then per local practice every 12 wks until second progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths |
| Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) | To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL. | Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO. |
| Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST) | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST). | Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
| Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST) | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST). | Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
| Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT) | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT). | Time elapsed from randomization to study treatment discontinuation or death. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
| Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS. | To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis). | Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO. |
| To Determine the Exposure to Olaparib by Pharmacokinetic Analysis | To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy | Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO. |
| San Francisco |
| California |
| United States |
| University of Colorado | Aurora | Colorado | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | United States |
| Gynecologic Cancer Center | Orlando | Florida | United States |
| North Shore University | Evanston | Illinois | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | United States |
| Johns Hopkins | Baltimore | Maryland | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| MD Anderson at Cooper Cancer Center | Voorhees Township | New Jersey | United States |
| Womens Cancer Care Associates | Albany | New York | United States |
| Winthrop Gynecologic Oncology Associates | Mineola | New York | United States |
| OSU JamesCare at Mill Run | Hilliard | Ohio | United States |
| Henry Joyce Cancer Clinic | Nashville | Tennessee | United States |
| Aurora St Lukes Medical Center | Milwaukee | Wisconsin | United States |
| Mercy Hospital for Women | Heidelberg | Australia |
| The Royal Womens Hospital | Parkville | Australia |
| Prince of Wales Hospital | Randwick | Australia |
| U.Z. Gent | Ghent | Belgium |
| UZ Leuven Gasthuisberg | Leuven | Belgium |
| Centro Diagnóstico Barretos | Barretos | Brazil |
| Centro Regional Integrado de Oncologia | Fortaleza | Brazil |
| Hospital Araujo Jorge | Goiânia | Brazil |
| Hospital de Caridade de Ijuí | Ijuí | Brazil |
| Centro de Novos Tratamentos Itajai | Itajaí | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Brazil |
| Irmandade da Santa Casa de Misericordia de Porto Alagre | Porto Alegre | Brazil |
| Hospital de Base São José do Rio Preto | São José do Rio Preto | Brazil |
| Centro de Referencia da Saude da Mulher | São Paulo | Brazil |
| Instituto do Câncer de São Paulo | São Paulo | Brazil |
| Juravinski Cancer Centre | Hamilton | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Center | Toronto | Ontario | Canada |
| CHUM - Hopital Norte-Dame | Montreal | Quebec | Canada |
| Hotel-Dieu de Quebec | Québec | Quebec | Canada |
| CHUS Site Fleurimont | Sherbrooke | Quebec | Canada |
| Beijing Cancer Hospital | Beijing | China |
| The Tumor Hospital affiliated to China Medical Science Insti | Beijing | China |
| 1st Hospital of Jilin university | Changchun | China |
| Jilin Provincial Cancer Hospital | Changchun | China |
| Hunan Cancer Hospital | Changsha | China |
| West China Hospital Affiliated to Sichuan University | Chengdu | China |
| ChongQing Cancer Hospital | Chongqing | China |
| Research Site | Guangzhou | 510060 | China |
| Women's Hospital, Zhejaing University School of Medicine | Hangzhou | China |
| The Tumour Hospital of Harbin Medical University | Harbin | China |
| Zhejiang Cancer Hospital, Huangzhou | Huangzhou | China |
| JINAN, Qi Lu Hosp. of SD Univ. | Jinan | China |
| Research Site | Shanghai | 200011 | China |
| Shanghai Cancer Hospital of Fudan University | Shanghai | China |
| The First Affiliated Hospital of Soochow University | Suzhou | China |
| First affiliated hospital college of XianJiaotong University | Xi'an | China |
| Institut Bergonie | Bordeaux | France |
| CAC François Baclesse | Caen | France |
| 69LYON, C Bérard, Onco | Lyon | France |
| Centre Catherine de Sienne | Nantes | France |
| 75PARIS, H Tenon, Onco | Paris | France |
| Hopital Européen Georges Pompidou | Paris | France |
| Institut Curie Paris Et Saint Cloud | Paris | France |
| 69PIERREBE, CH Lyon Sud, | Pierre-Bénite | France |
| 92STCLOUD, C Huguenin, Onco | Saint-Cloud | France |
| Institut Claudius Regaud | Toulouse | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | France |
| Institut Gustave Roussy | Villejuif | France |
| Helios-Kliniken Berlin - Buch | Berlin | Germany |
| Friedrich-Alexander-Universität Erlangen-Nürnberg | Erlangen | Germany |
| Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH | Essen | Germany |
| Johann-Wolfgang Goethe-Universität | Frankfurt | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Germany |
| Klinikum rechts der Isar der Technischen Universität | München | Germany |
| Onkologie Ravensburg | Ravensburg | Germany |
| Universitätsklinikum Rostock | Rostock | Germany |
| Rambam Health Care Campus | Haifa | Israel |
| Sapir Medical Centre | Kfar Saba | Israel |
| Tel Hashomer | Ramat Gan | Israel |
| Istituto Europeo di Oncologia | Milan | Italy |
| Azienda Ospedaliera Policlinico Di Modena | Modena | Italy |
| Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy |
| Istituto Oncologico Veneto Irccs | Padova | Italy |
| Istituto Regina Elena-Polo Oncologico Ifo | Roma | Italy |
| Policlinico Universitario A. Gemelli | Roma | Italy |
| Hyogo Cancer Center | Akashi-shi | Japan |
| National Cancer Center Hospital | Chūōku | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Japan |
| Saitama Medical University International Medical Center | Hidaka-shi | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Japan |
| Niigata University Medical and Dental Hospital | Niigata | Japan |
| Kindai University Hospital | Osakasayama-shi | Japan |
| Hokkaido University Hospital | Sapporo | Japan |
| Shizuoka Cancer Center | Sunto-gun | Japan |
| Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital | Amsterdam | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | Netherlands |
| Universitair Medisch Centrum St. Radboud | Nijmegen | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | Netherlands |
| Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna | Grzepnica | Poland |
| SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii | Olsztyn | Poland |
| Wojewódzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Poland |
| Centrum Onkologii Instytut im Marii Sklodowskiej-Curie | Warsaw | Poland |
| Szpital Specjalistyczny im. Swietej Rodziny SPZOZ | Warsaw | Poland |
| Chemotherapy Department, Russian Cancer Research Centre | Moscow | Russia |
| Leningrad Regional Oncology Dispensary | Saint Petersburg | Russia |
| St.Petersburg City Oncology Dispensary, Dept. Gynecology | Saint Petersburg | Russia |
| Asan Medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Barcelona,H.Clinic i Provincial,Oncología | Barcelona | Spain |
| Barcelona,H.de la Sta.Creu i S.Pau,Oncología | Barcelona | Spain |
| Córdoba,H.Reina Sofía,Oncología | Córdoba | Spain |
| Gerona,H.Josep Trueta,Oncología | Girona | Spain |
| Madrid, H.C.S.Carlos,Oncología | Madrid | Spain |
| Madrid,H.12 de Octubre,Oncología | Madrid | Spain |
| Hospital Provincial de Navarra | Pamplona | Spain |
| Valencia, IVO, Oncología | Valencia | Spain |
| Valencia,H.C.U.Valencia,Oncología | Valencia | Spain |
| City Hospital Birmingham Cancer Trials Team | Birmingham | United Kingdom |
| Addenbrooke's Hospital | Cambridge | United Kingdom |
| Arden Cancer Centre | Coventry | United Kingdom |
| Edinburgh Cancer Research UK Centre | Edinburgh | United Kingdom |
| Cancer Research UK and UCL Cancer Trials Centre | London | United Kingdom |
| Royal Marsden Hospital | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| Royal Marsden Hospital and Institute of Cancer Research | Sutton | United Kingdom |
| Derived |
| Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5. |
| 35772665 | Derived | Frenel JS, Kim JW, Aryal N, Asher R, Berton D, Vidal L, Pautier P, Ledermann JA, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Colombo N, Park-Simon TW, Tamura K, Sonke GS, Freimund AE, Lee CK, Pujade-Lauraine E. Efficacy of subsequent chemotherapy for patients with BRCA1/2-mutated recurrent epithelial ovarian cancer progressing on olaparib versus placebo maintenance: post-hoc analyses of the SOLO2/ENGOT Ov-21 trial. Ann Oncol. 2022 Oct;33(10):1021-1028. doi: 10.1016/j.annonc.2022.06.011. Epub 2022 Jun 27. |
| 35170751 | Derived | Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4. |
| 33743851 | Derived | Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. doi: 10.1016/S1470-2045(21)00073-5. Epub 2021 Mar 18. |
| 32977221 | Derived | Tjokrowidjaja A, Lee CK, Friedlander M, Gebski V, Gladieff L, Ledermann J, Penson R, Oza A, Korach J, Huzarski T, Manso L, Pisano C, Asher R, Lord SJ, Kim SI, Lee JY, Colombo N, Park-Simon TW, Fujiwara K, Sonke G, Vergote I, Kim JW, Pujade-Lauraine E. Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy. Eur J Cancer. 2020 Nov;139:59-67. doi: 10.1016/j.ejca.2020.08.021. Epub 2020 Sep 23. |
| 30026002 | Derived | Friedlander M, Gebski V, Gibbs E, Davies L, Bloomfield R, Hilpert F, Wenzel LB, Eek D, Rodrigues M, Clamp A, Penson RT, Provencher D, Korach J, Huzarski T, Vidal L, Salutari V, Scott C, Nicoletto MO, Tamura K, Espinoza D, Joly F, Pujade-Lauraine E. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol. 2018 Aug;19(8):1126-1134. doi: 10.1016/S1470-2045(18)30343-7. Epub 2018 Jul 17. |
| 28754483 | Derived | Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2. Epub 2017 Jul 25. |
| FG002 | Olaparib 300mg Tablets (China Cohort) | Taken orally twice daily |
| FG003 | Placebo Tablets (China Cohort) | Taken orally twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Global Cohort: 196 Olaparib, 99 Placebo China Cohort: 22 Olaparib, 10 Placebo
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib 300mg Tablets | Taken orally twice daily |
| BG001 | Placebo Tablets | Taken orally twice daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109) | Mean | Standard Deviation | Years |
| ||||||||||||||
| Age, Customized | There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109) | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109) | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109) | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) | To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment, excluding China [Primary analysis] China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months. |
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| Secondary | Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS). | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
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| Secondary | Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death. | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | CA-125 at baseline then every 4 wks. Radiologic scans at baseline then every ~12 wks up to 72 wks, then every ~ 24 wks until objective radiological disease progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths. |
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| Secondary | Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | Scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. Assessments then per local practice every 12 wks until second progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths |
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| Secondary | Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) | To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL. | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) with a baseline and post baseline TOI score available [This endpoint was not assessed in the China Cohort] | Posted | Least Squares Mean | 95% Confidence Interval | Change in TOI over 12 months | Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO. |
|
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| Secondary | Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST) | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST). | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
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| Secondary | Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST) | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST). | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
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| Secondary | Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT) | To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT). | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China. | Posted | Median | 95% Confidence Interval | Months | Time elapsed from randomization to study treatment discontinuation or death. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months. |
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| Secondary | Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS. | To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis). | Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) and confirmed as Myriad gBRCAm [This endpoint was not assessed in the China Cohort] | Posted | Median | 95% Confidence Interval | Months | Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO. |
|
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| Secondary | To Determine the Exposure to Olaparib by Pharmacokinetic Analysis | To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy | Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data. The PK Analysis Set is a subset of the Global FAS; PK analysis was not performed in the China Cohort. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO. |
|
|
Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olaparib 300 Tablets (Global Cohort) | Taken orally twice daily | 116 | 196 | 50 | 195 | 192 | 195 |
| EG001 | Placebo Tablets (Global Cohort) | Taken orally twice daily | 65 | 99 | 8 | 99 | 91 | 99 |
| EG002 | Olaparib 300 Tablets (China Cohort) | Taken orally twice daily | 13 | 22 | 5 | 22 | 21 | 22 |
| EG003 | Placebo Tablets (China Cohort) | Taken orally twice daily | 7 | 10 | 1 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
The outbreak of the COVID-19 pandemic shortly before the final OS DCO (03 February 2020) was not judged to meaningfully impact the overall quality of the study, including the conduct, data, and interpretation of results.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Program Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C531550 | olaparib |
Not provided
Not provided
Not provided
| China Cohort |
|
|
|
| China Cohort |
|
|
|
| China Cohort |
|
|
|
| China Cohort |
|
|
|
| China Cohort |
|
|
| Regression, Cox | Model includes a treatment factor only | Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only. | Hazard Ratio (HR) | 0.44 | 2-Sided | 95 | 0.17 | 1.19 | A hazard ratio < 1 favours olaparib | Superiority or Other (legacy) |
Taken orally twice daily |
|
|
|
| OG003 | Placebo Tablets (China Cohort) | Taken orally twice daily |
|
|
|
| OG003 | Placebo Tablets (China Cohort) | Taken orally twice daily |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Placebo Tablets (China Cohort) |
Taken orally twice daily |
|
|
|
| Placebo Tablets (China Cohort) |
Taken orally twice daily |
|
|
|
| Placebo Tablets (China Cohort) |
Taken orally twice daily |
|
|
|
|
|
|