Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.
A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib+ paclitaxel | Experimental | olaparib + paclitaxel |
|
| Placebo+paclitaxel | Placebo Comparator | placebo+ paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from the date of randomization until death due to any cause | Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yung-Jue Bang, MD | Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100021 | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29103871 | Derived | Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, Qin S, Xu N, Im SA, Locker G, Rowe P, Shi X, Hodgson D, Liu YZ, Boku N. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1637-1651. doi: 10.1016/S1470-2045(17)30682-4. Epub 2017 Nov 2. |
| Label | URL |
|---|---|
| Study 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
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 deidentified 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.
The number of participants in the participant flow (525) includes all participants who were eligible and assigiend to each treatment group.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2 |
| FG001 | Placebo Tablets bd + Paclitaxel 80 mg/m^2 | Placebo tablets bd + Paclitaxel 80 mg/m^2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paclitaxel | Drug | IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule. |
|
| Placebo | Drug | Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily. |
|
| Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
| Number of Patients With Objective Response. | Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR. | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
| Number of Patients Objective Response | Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR. | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
| Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale | Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration | Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years |
| Time to Response | Time from randomization to the first onset of a confirmed objective tumour response | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
| Duration of Response | Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
| Beijing |
| 100071 |
| China |
| Research Site | Beijing | 100142 | China |
| Research Site | Bengbu | 233060 | China |
| Research Site | Changchun | 130000 | China |
| Research Site | Changsha | 410005 | China |
| Research Site | Changsha | 410011 | China |
| Research Site | Changsha | 410013 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chengdu | 610083 | China |
| Research Site | Fuzhou | 350014 | China |
| Research Site | Guangzhou | 510060 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hangzhou | 310016 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Harbin | 150081 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanjing | 210002 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200092 | China |
| Research Site | Ürümqi | 830000 | China |
| Research Site | Wanzhou | 404000 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Yangzhou | 225001 | China |
| Research Site | Zhengzhou | 450008 | China |
| Research Site | Chiba | 260-8717 | Japan |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 811-1395 | Japan |
| Research Site | Kasama-shi | 309-1793 | Japan |
| Research Site | Kawasaki-shi | 216-8511 | Japan |
| Research Site | Kitaadachi-gun | 362-0806 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Nagoya | 464-8681 | Japan |
| Research Site | Sapporo | 003-0804 | Japan |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Takatsuki-shi | 569-8686 | Japan |
| Research Site | Utsunomiya | 320-0834 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Anyang-si | 431-070 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Hwasun-gun | 58128 | South Korea |
| Research Site | Jeonju | 561-712 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 06273 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 156-707 | South Korea |
| Research Site | Seoul | 6351 | South Korea |
| Research Site | Kaohsiung Hsien | 83342 | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| CSR Synopsis | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2 |
| BG001 | Placebo Tablets bd + Paclitaxel 80 mg/m^2 | Placebo tablets bd + Paclitaxel 80 mg/m^2 |
| 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, Continuous | ATM Negative Population | The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population. | Mean | Standard Deviation | Years |
| |||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Age, Customized | ATM Negative Population | The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population. | Count of Participants | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | ATM Negative Population | The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population. | Count of Participants | Participants |
| ||||||||||||||
| Race/Ethnicity, Customized | ATM Negative Population | The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population. | Count of Participants | Participants |
| ||||||||||||||
| ATM Status | Number | Participants |
| ||||||||||||||||
| Gastrectomy Status | Count of Participants | Participants |
| ||||||||||||||||
| Gastrectomy Status | ATM Negative Population | The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population. | 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 | Overall Survival | Time from the date of randomization until death due to any cause | Full analysis set population | Posted | Number | participants | Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival | Time from the date of randomization until death due to any cause | Full analysis set - ATM negative population | Posted | Number | participants | Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion. | FAS analysis set population | Posted | Number | participants | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion. | FAS analysis set - ATM negative population | Posted | Number | participants | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Objective Response. | Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR. | Full analysis set population | Posted | Number | participants | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Objective Response | Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR. | Full analysis set - ATM negative population | Posted | Number | participants | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale | Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration | Patients whose baseline HRQoL score >=10 in full analysis set population | Posted | Number | participants | Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale | Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration | Patients whose baseline HRQoL score >=10 in full analysis set ATM negative population | Posted | Number | participants | Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time from randomization to the first onset of a confirmed objective tumour response | Patients with objective response in full analysis set population | Posted | Median | Inter-Quartile Range | days | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time from randomization to the first onset of a confirmed objective tumour response | Patients with objective response in full analysis set ATM negative population | Posted | Median | Inter-Quartile Range | days | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits | Patients with objective response in full analysis set population | Posted | Median | Inter-Quartile Range | days | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits | Patients with objective response in full analysis set ATM negative population | Posted | Median | Inter-Quartile Range | days | Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years |
|
|
Not provided
Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
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 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2 | 181 | 263 | 92 | 262 | 257 | 262 |
| EG001 | Placebo Tablets bd + Paclitaxel 80 mg/m^2 | Placebo tablets bd + Paclitaxel 80 mg/m^2 | 200 | 262 | 65 | 259 | 253 | 259 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bone marrow disorder | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dilatation intrahepatic duct acquired | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Atypical mycobacterial infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Scrub typhus | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Coagulation test abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Granulocyte count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Stent malfunction | Product Issues | MedDRA 19.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
At least 60 days prior to submission of any material for publication or presentation, Institution and Principal Investigator (PI) shall jointly provide AstraZeneca with such material for review. If requested in writing by AstraZeneca, Institution and PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of AstraZeneca's request to allow for the filing patent application or preserve its proprietary rights in the information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gershon Locker Global Clinical Lead (GCL) | AstraZeneca | gershon.locker@astrazeneca.com |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531550 | olaparib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
|
|
| >=50 - <65 |
|
|
| >=65 |
|
|
|
| >=50 - <65 |
|
|
| >=65 |
|
|
|
|
|
|
|
|
| Positive |
|
|
| Unknown |
|
|
|
| None |
|
|
| Partial |
|
|
|
| Partial |
|
|
| None |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|