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A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA (BReast CAncer gene) 1/2 Mutation
A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA(BReast CAncer gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the current phase-IV study is planned with the aim to assess the safety in Indian subjects receiving olaparib as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. This study attempts to descriptively elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian regulatory approved indications in India. The data obtained from the present study will help to understand the safety profile of olaparib in Indian patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Intervention: Drug: Olaparib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment | Baseline to EOT (approximately 6 months) |
| Haematology: Haemoglobin Parameters | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment | Baseline to EOT (approximately 6 months) |
| Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment |
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Inclusion Criteria:
Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures..
Female Subjects with ≥ 18 years of age
Subjects receiving olaparib for the following indications in ovarian cancer:
for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
Subjects receiving olaparib for the following indication in breast cancer:
in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ahmedabad | 380009 | India | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted CSP | View source |
| Redacted SAP | 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.
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Participants who were prescribed olaparib by an independent clinical judgement of investigator in his/her routine practice based on locally approved prescribing information were eligible for screening under this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ovarian Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| FG001 | Breast Cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2019 | Sep 21, 2023 |
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A Prospective, Multicentre, Phase-IV Clinical Trial
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| Baseline to EOT (approximately 6 months) |
| Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment | Baseline to EOT (approximately 6 months) |
| Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment | Baseline to EOT (approximately 6 months) |
| Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal clinically significant results at Baseline and EOT are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. | Baseline to EOT (approximately 6 months) |
| Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment | Baseline to EOT (approximately 6 months) |
| WHO Performance Status | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. | Baseline and End of study visit (200 days) |
| Bhubaneswar |
| 751007 |
| India |
| Research Site | Chandigarh | 160012 | India |
| Research Site | Delhi | 110029 | India |
| Research Site | Faridabad | 121001 | India |
| Research Site | Guwahati | 781023 | India |
| Research Site | Kochi | 682041 | India |
| Research Site | Kolkata | 700099 | India |
| Research Site | Kolkata | 700160 | India |
| Research Site | Madurai | 625107 | India |
| Research Site | Mumbai | 400012 | India |
| Research Site | Mumbai | 400053 | India |
| Research Site | New Delhi | 110 085 | India |
| Research Site | New Delhi | 110005 | India |
| Research Site | New Delhi | 110063 | India |
| Research Site | Vellore | 632004 | India |
| Redacted CSR Synopsis | View source |
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
| FG002 | Both Ovarian Cancer and Breast Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Ovarian Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| BG001 | Breast Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| BG002 | Both Ovarian Cancer and Breast Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| BG003 | 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 |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Body mass index | Mean | Standard Deviation | kg/m2 |
| ||||||||||
| Child Bearing Potential | Count of Participants | Participants |
| |||||||||||
| Stage/FIGO Stage of Cancer at Screening | The higher the stage and grade of the cancer, the larger the tumor and the more it has spread. Cancers that are in higher stages have a worse prognosis. | Count of Participants | Participants |
| ||||||||||
| Previous Cancer Therapy | Count of Participants | Participants |
| |||||||||||
| WHO Performance Status | WHO = World Health Organization | 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 | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Haematology: Haemoglobin Parameters | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal clinically significant results at Baseline and EOT are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. | Safety Analysis Set | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline to EOT (approximately 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | WHO Performance Status | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. | The safety analysis set included all participants who received the study drug (200 overall). | Posted | Count of Participants | Participants | Baseline and End of study visit (200 days) |
|
6 months
Events with start date on or after the date of first dose of study treatment until 28 days after last dose of study treatment. Adverse events that were a consequence of a pre-existing condition that worsened later during the treatment phase (ie, events having start date before the date of first dose of study treatment and have worsened in severity while on study treatment) were termed as 'Treatment-emergent'.
Adverse events for the Safety Analysis Set are presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ovarian Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). | 3 | 161 | 24 | 161 | 148 | 161 |
| EG001 | Breast Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). | 3 | 38 | 7 | 38 | 30 | 38 |
| EG002 | Both Ovarian Cancer and Breast Cancer | Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaria | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Retinal vascular occlusion | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspiration pleural cavity | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2023 | Sep 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531550 | olaparib |
Not provided
Not provided
Not provided
|
|
|
|
|
| No |
|
|
|
|
|
| EOT Normal |
|
| EOT Below Normal |
|
| EOT Missing |
|
| Eosinophils Absolute Count |
|
| Leucocytes WBC |
|
| Lymphocytes Absolute Count |
|
| Monocytes Absolute Count |
|
| Neutrophils Absolute Count |
|
| Platelets |
|
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
| OG003 | Cancer Type: Overall | All participants included in this analysis |
|
|
| Both Ovarian and Breast Cancer |
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| OG003 | Cancer Type: Overall | All participants included in this analysis |
|
|
| Both Ovarian and Breast Cancer |
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). |
| OG003 | Cancer Type: Overall | All participants included in this analysis |
|
|
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
|
|
|
Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8).
|
|
| OG003 | Cancer Type: Overall | All participants included in this analysis |
|
|
| Respiratory |
|
| Cardiovascular |
|
| Abdomen |
|
| Lymph Nodes |
|
| Musculoskeletal system |
|
| No response |
|
| Restricted activity |
|
| In bed less than or equal to 50% of the time |
|
| Title | Measurements |
|---|---|
| Normal activity |
|
| Restricted activity |
|
| In bed less than or equal to 50% of the time |
|