Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015970-36 | EudraCT Number |
Not provided
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To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. |
|
| 2 | Active Comparator | paclitaxel iv and carboplatin iv |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olaparib | Drug | Tablets Oral BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). | Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. Updated OS based on final OS analysis (DCO 31 January 2014) | Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Amit Oza, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stanford | California | 94305 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 25554012 | Derived | Gunderson CC, Moore KN. PARP inhibition in ovarian cancer: state of the science. Gynecol Oncol. 2015 Jan;136(1):8-10. doi: 10.1016/j.ygyno.2014.12.009. No abstract available. |
| Label | URL |
|---|---|
| CSR-D0810C00041.pdf | View source |
Not provided
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.
Patient randomisation was stratified(using an interactive voice response [IVR]system) based on:1) number of prior platinum-containing treatment lines received(1or>1) and 2)time to disease progression following completion of the previous platinum-containing therapy(>6to<=12 months or>12 months).Six patients in the C6/P arm did not receive treatment.
The first patient was enrolled on 12-Feb-2010. The last patient was enrolled on 15-Jul-2010. Patients were enrolled at 43 sites in 12 countries: Australia, Belgium, Canada, Czech Republic, Germany, Italy, Japan, the Netherlands, Panama, Spain, the UK and the USA. 173 patients were screened and 162 patients were enrolled to receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib/Carboplatin AUC4/Paclitaxel | Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| paclitaxel |
| Drug |
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle |
|
|
| carboplatin | Drug | AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle |
|
| paclitaxel | Drug | 175mg/m2 iv for up to 6 cycles (18 weeks) |
|
| Drug: carboplatin | Drug | AUC4 iv for up to 6 cycles (18 weeks) |
|
| Percentage Change in Tumour Size | The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible. | Week 9 (+/- 1 week) |
| West Hollywood |
| California |
| 90048 |
| United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Portland | Oregon | 97227-1191 | United States |
| Research Site | Parkville | 3050 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | Brussels | 1090 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Namur | 5000 | Belgium |
| Research Site | Wilrijk | 2610 | Belgium |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Québec | Quebec | G1R 2J6 | Canada |
| Research Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 120 00 | Czechia |
| Research Site | Essen | 45147 | Germany |
| Research Site | Frankfurt | 60590 | Germany |
| Research Site | Hamburg | 20246 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | Solingen | 42653 | Germany |
| Research Site | Genova | 16132 | Italy |
| Research Site | Milan | 20141 | Italy |
| Research Site | Monza | 20052 | Italy |
| Research Site | Torino | 10126 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 811-1395 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Morioka | 028-3695 | Japan |
| Research Site | Shinjuku-ku | 160-8582 | Japan |
| Research Site | Yamagata | 990-9585 | Japan |
| Research Site | Yonago-shi | 683-8504 | Japan |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Amsterdam | 1105 AZ | Netherlands |
| Research Site | Nijmegen | 6525 GA | Netherlands |
| Research Site | Rotterdam | 3015 GD | Netherlands |
| Research Site | Panama City | 2723 | Panama |
| Research Site | Lima | LIMA 27 | Peru |
| Research Site | Lima | LIMA 41 | Peru |
| Research Site | Madrid | 08035 | Spain |
| Research Site | Valencia | 46010 | Spain |
| Research Site | Birmingham | B18 7QH | United Kingdom |
| Research Site | Coventry | CV2 2DX | United Kingdom |
| Research Site | Edinburgh | EH4 2XR | United Kingdom |
| 25481791 | Derived | Oza AM, Cibula D, Benzaquen AO, Poole C, Mathijssen RH, Sonke GS, Colombo N, Spacek J, Vuylsteke P, Hirte H, Mahner S, Plante M, Schmalfeldt B, Mackay H, Rowbottom J, Lowe ES, Dougherty B, Barrett JC, Friedlander M. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial. Lancet Oncol. 2015 Jan;16(1):87-97. doi: 10.1016/S1470-2045(14)71135-0. Epub 2014 Dec 4. |
| Carboplatin AUC6/Paclitaxel |
Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered |
| Received Study Treatment |
|
| Entered Maintenance Phase |
|
| Ongoing Study Treatment at Data Cut-off |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib/Carboplatin AUC4/Paclitaxel | Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing) |
| BG001 | Carboplatin AUC6/Paclitaxel | Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Number of prior platinum-containing treatment lines | Count of Participants | Participants |
| ||||||||||||||||
| Time to disease progression on completion of the previous platinum therapy | Count of Participants | Participants |
| ||||||||||||||||
| Classification of BRCA status | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | months | Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. Updated OS based on final OS analysis (DCO 31 January 2014) | FAS | Posted | Number | Participants (Number of deaths) | Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Tumour Size | The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible. | FAS, but including only patients with target lesions at baseline | Posted | Least Squares Mean | Standard Error | Percentage change | Week 9 (+/- 1 week) |
|
|
Not provided
Adverse events were assessed on the Safety population consisting of patients who received treatment (N=156) while all-cause mortality was assessed on all patients randomized (N=162).
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/Carboplatin AUC4/Paclitaxel | Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles. Followed by olaparib monotherapy maintenance (400mg bd continuous dosing) | 54 | 81 | 17 | 81 | 81 | 81 |
| EG001 | Carboplatin AUC6/Paclitaxel | Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles. Followed by a post-completion phase in which no study treatment was administered | 47 | 81 | 19 | 75 | 72 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointestinal Obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hepatitis Acute | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Coagulation Time Prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@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 |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| ≥ 50 - < 65 |
|
| ≥ 65 |
|
| Male |
|
| >1 |
|
| PD >12 months after completion |
|
| BRCAwt |
|
| BRCA VUS |
|
| BRCA missing |
|
| Superiority or Other (legacy) |
|
|
|
| Participants |
|
|