Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022278-15 | EudraCT Number |
Not provided
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To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response
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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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olaparib | Drug | Tablets Oral BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumour Response Rate | Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson, BSc, MBCHB, MD | AstraZeneca | Study Director |
| Bella Kaufman, MD | Chaim Sheba Medical Centre, Tel Hashomer, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | West Hollywood | California | 90048 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26961146 | Derived | Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8. | |
| 26723501 |
| Label | URL |
|---|---|
| Protocol redacted | 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.
Patients >17 years age with histologically and/or cytologically confirmed malignant solid tumours, refractory to standard therapy for which no suitable effective/curative therapy. Patients with confirmed deleterious or suspected deleterious BRCA mutation, Eastern Co-operative Oncology Group performance status ≤2 and life expectancy of ≥12 weeks.
In total, 298 patients had received treatment.
This study was conducted at 13 sites across Israel, Germany, Spain, Australia, USA, Sweden. Enrolment started in Feb 2010 and was completed in Jul 2012. In total, 298 patients had received treatment (olaparib).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Breast Cancer | Patients with primary cancer site = breast. Receiving olaparib 400mg BID |
| FG001 | Ovarian Cancer | Patients with primary cancer site = ovary. Receiving olaparib 400mg BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Progression Free Survival | Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit. | Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months |
| Overall Survival | Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive. | Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months |
| Overall Survival Rate at 12 Months | Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose | Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months |
| Duration of Response | Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression. | From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months |
| Disease Control Rate at Week 16 | Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16. | Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Research Site | Melbourne | 3000 | Australia |
| Research Site | Randwick | 2031 | Australia |
| Research Site | Cologne | 50931 | Germany |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Haifa | 35152 | Israel |
| Research Site | Jerusalem | 91031 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Ramat Gan | 52621 | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Madrid | 08035 | Spain |
| Research Site | Lund | 221 85 | Sweden |
| Derived |
| Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. doi: 10.1016/j.ygyno.2015.12.020. Epub 2015 Dec 23. |
| CSP Redacted | View source |
| FG002 | Pancreatic Cancer | Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID |
| FG003 | Prostate Cancer | Patients with primary cancer site = prostate. Receiving olaparib 400mg BID |
| FG004 | Other Cancers | Patients with other primary cancers. Receiving olaparib 400mg BID |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Breast Cancer | Patients with primary cancer site = breast. Receiving olaparib 400mg BID |
| BG001 | Ovarian Cancer | Patients with primary cancer site = ovary. Receiving olaparib 400mg BID |
| BG002 | Pancreatic Cancer | Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID |
| BG003 | Prostate Cancer | Patients with primary cancer site = prostate. Receiving olaparib 400mg BID |
| BG004 | Other Cancers | Patients with other primary cancers. Receiving olaparib 400mg BID |
| BG005 | 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 | Age at time of screening | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Age by category | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Gender | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race | 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 | Tumour Response Rate | Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Full analysis set - all treated patients | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). | Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit. | Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol. | Posted | Median | Inter-Quartile Range | months | Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive. | Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol. | Posted | Median | Inter-Quartile Range | months | Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate at 12 Months | Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose | Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol. | Posted | Number | Percentage of participants | Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression. | Full analysis set - all treated patients who had at least one complete or partial response during the assessment period. | Posted | Median | Inter-Quartile Range | days | From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate at Week 16 | Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16. | Full analysis set - all treated patients | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16 |
|
Not provided
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 | 90 | 298 | 290 | 298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| INTESTINAL MASS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DEVICE RELATED SEPSIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 15 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| GASTROINTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DEVICE OCCLUSION | General disorders | MedDRA 15 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 15 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| ENTEROBACTER SEPSIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| HAEMARTHROSIS | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 15 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 15 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 15 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 15 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anitra Fielding | AstraZeneca | +44 1625 517178 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| C531550 | olaparib |
Not provided
Not provided
Not provided
| >=50 to <65 years |
|
| >= 65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Prostate Cancer |
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID |
| OG004 | Other Cancers | Patients with other primary cancers. Receiving olaparib 400mg BID |
| OG005 | All Patients | Patients of different cancer types |
|
|
Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG004 | Other Cancers | Patients with other primary cancers. Receiving olaparib 400mg BID |
| OG005 | All Patients | Patients of different cancer types |
|
|
| OG004 | Other Cancers | Patients with other primary cancers. Receiving olaparib 400mg BID |
| OG005 | All Patients | Patients of different cancer types |
|
|