Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AENCT06324734
Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting
An observational study of Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE, run by AstraZeneca at 1 site in China.
Trial summary
Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE
- How many people
- 2,506 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2024to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients (age>=18 years) who were newly diagnosed advanced or platinum sensitive recurrence epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and used Olaparib（monotherapy or in combination with Bevacizumab in 1L maintenance setting， or monotherapy in PSR setting） during the study timeframe will be included in the study. Patients will be excluded if they don't have any visit record post use of Olaparib or they were enrolled in the other Olaparib Intensive Monitoring Studies (D0816C00016 and D0817R00011) conducted by AstraZeneca.
Who may be able to join
- Patients newly diagnosed with advanced or platinum sensitive recurrence epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (FIGO stage III-IV) treated with Olaparib+/-Bevacizumab according to approved label indications in China;
- Patients with at least one prescription record of Olaparib between August 01, 2018 and June 30, 2023;
- Age ≥18 years at first use of Olaparib;
- At least one visit record after the first use of Olaparib.
Who cannot join
- Patients enrolled in the other Olaparib DIM Programs (D0816C00016 and D0817R00011) conducted by AstraZeneca.
- Patients newly diagnosed with stage I and stage II ovarian cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021
About this study
Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction, interruption or discontinuation of Olaparib. The first Olaparib prescription date will be set as the index date. The baseline period is from the patient's first ovarian cancer diagnosis recorded in the database to the patient's first treatment with Olaparib (as early as the database start date of January 1, 2013) to the index date for derivation of lines of therapy or one year pre-index date for other baseline variables. Patients will be followed until the patient's last medical record in the database, 30 days after the last dose of Olaparib, death, or June 30, 2023, whichever comes first. All patients who meet the inclusion/exclusion criteria will be enrolled.
Read the detailed description
Olaparib (Lynparza, formerly referred to as AZD2281 or KU-0059436), is a highly potent polyadenosine diphosphate ribose polymerase (PARP) inhibitor and the first in class approved for use in monotherapy (including maintenance therapy) as well as in combination with other chemotherapeutic agents. It is available in two strengths, 150mg and 100mg. The recommended dosage for Olaparib is 300mg (two 150mg tablets) taken twice daily, resulting in a total daily dose of 600mg. The 100mg strength tablet is used for dose reduction purposes. In August 2018, based on the findings of the trials, Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer (Study 19, NCT00753545) and Olaparib Treatment in Breast Cancer Gene (BRCA) Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy (SOLO-2, NCT01874353), China National Medical Products Administration (NMPA) approved Olaparib tablets for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer,or primary peritoneal cancer who have achieved a complete or partial response to platinum-bSAEd chemotherapy. In November 2019, based on the results of the trial, Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy (SOLO-1, NCT01844986), Olaparib received approval for the maintenance treatment of treatment-naïve adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have germline BRCA mutations (gBRCAm) or somatic BRCA mutations (sBRCAm) and have achieved a complete or partial response to first-line platinum-based chemotherapy in China. Furthermore, in September 2022, based on the in PAOLA-1 study in front-line advanced ovarian cancer (NCT02477644), Olaparib in combination with Bevacizumab was approved for the maintenance treatment of adult patients with homologous recombination deficiency (HRD)-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to first-line platinum-based chemotherapy in China. Lynparza has been reported to be associated with mild or moderate adverse reactions [grade 1 or 2 according to the Common Terminology Criteria for Adverse Events (CTCAE)] and generally not requiring treatment discontinuation. In accordance with the Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring (Order No.81 of the Ministry of Health), it is recommended to monitor the safety profile of newly approved drugs in real-world settings. Post-marketing real-world studies closely reflect clinical practice and provide a comprehensive understanding of the product's safety profile compared to premarketing Phase II/III studies. Currently, there is a limited number of safety studies focusing on Chinese patients with ovarian cancer conducted in routine clinical practice, and these studies have small sample size. This study aims to assess the safety of Olaparib in Chinese ovarian cancer patients treated in real-world clinical practice by retrospectively analysing electronic medical records (EMR) of ovarian cancer patients who received Olaparib in China from August 2018 to June 2023, documented in the National Cancer Information Database (NCID).
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence, seriousness, and severity of all AEs
To assess the safety of Olaparib in Chinese ovarian cancer patients in real-world clinical practice by examining the incidence, seriousness, and severity of all adverse events (AEs), including but not limiting to adverse events of special interest (AESIs), serious adverse events (SAEs), AEs causally related to Olaparib, and AEs leading to dose reduction, interruption, or discontinuation of Olaparib.(classified by 1st Line(1L) 1L Olaparib mono,1L Olaparib
+Bevacizumab, Platinum Sensitive Recurrence(PSR) Olaparib mono)
Measured: August 1, 2018 to June 30, 2023.
Secondary outcomes (2)
The number and proportion of patients according to different baseline demographics and characteristics
To describe the baseline demographics and clinical characteristics of Chinese ovarian cancer patients treated with Olaparib in real-world clinical practice and to assess the safety of Olaparib in different subgroups. The subgroup analysis will be conducted according to age, comorbidities , gene status，stage, number of lines of chemotherapy, duration of Olaparib treatment, etc.
Measured: August 1, 2018 to June 30, 2023.
Overall number and proportion of patients with olaprib combination maintenance therapy in PSR patients
To describe the baseline demographics and clinical characteristics of Chinese ovarian cancer patients treated with Olaparib in real-world clinical practice and to assess the safety of Olaparib in different subgroups. The subgroup analysis will be conducted according to age, comorbidities , gene status，stage, number of lines of chemotherapy, duration of Olaparib treatment, etc.
Measured: August 1, 2018 to June 30, 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start29 Apr 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AEStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lingying Wu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324734
- Sponsor's protocol ID
- D0817R00082
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting
- ClinicalTrials.gov ID
- NCT06324734
- Acronym / sponsor ID
- D0817R00082
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,506 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction, interruption or discontinuation of Olaparib. The first Olaparib prescription date will be set as the index date. The baseline period is from the patient's first ovarian cancer diagnosis recorded in the database to the patient's first treatment with Olaparib (as early as the database start date of January 1, 2013) to the index date for derivation of lines of therapy or one year pre-index date for other baseline variables. Patients will be followed until the patient's last medical record in the database, 30 days after the last dose of Olaparib, death, or June 30, 2023, whichever comes first. All patients who meet the inclusion/exclusion criteria will be enrolled.
Detailed description
Olaparib (Lynparza, formerly referred to as AZD2281 or KU-0059436), is a highly potent polyadenosine diphosphate ribose polymerase (PARP) inhibitor and the first in class approved for use in monotherapy (including maintenance therapy) as well as in combination with other chemotherapeutic agents. It is available in two strengths, 150mg and 100mg. The recommended dosage for Olaparib is 300mg (two 150mg tablets) taken twice daily, resulting in a total daily dose of 600mg. The 100mg strength tablet is used for dose reduction purposes. In August 2018, based on the findings of the trials, Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer (Study 19, NCT00753545) and Olaparib Treatment in Breast Cancer Gene (BRCA) Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy (SOLO-2, NCT01874353), China National Medical Products Administration (NMPA) approved Olaparib tablets for the maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer,or primary peritoneal cancer who have achieved a complete or partial response to platinum-bSAEd chemotherapy. In November 2019, based on the results of the trial, Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy (SOLO-1, NCT01844986), Olaparib received approval for the maintenance treatment of treatment-naïve adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have germline BRCA mutations (gBRCAm) or somatic BRCA mutations (sBRCAm) and have achieved a complete or partial response to first-line platinum-based chemotherapy in China. Furthermore, in September 2022, based on the in PAOLA-1 study in front-line advanced ovarian cancer (NCT02477644), Olaparib in combination with Bevacizumab was approved for the maintenance treatment of adult patients with homologous recombination deficiency (HRD)-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to first-line platinum-based chemotherapy in China. Lynparza has been reported to be associated with mild or moderate adverse reactions [grade 1 or 2 according to the Common Terminology Criteria for Adverse Events (CTCAE)] and generally not requiring treatment discontinuation. In accordance with the Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring (Order No.81 of the Ministry of Health), it is recommended to monitor the safety profile of newly approved drugs in real-world settings. Post-marketing real-world studies closely reflect clinical practice and provide a comprehensive understanding of the product's safety profile compared to premarketing Phase II/III studies. Currently, there is a limited number of safety studies focusing on Chinese patients with ovarian cancer conducted in routine clinical practice, and these studies have small sample size. This study aims to assess the safety of Olaparib in Chinese ovarian cancer patients treated in real-world clinical practice by retrospectively analysing electronic medical records (EMR) of ovarian cancer patients who received Olaparib in China from August 2018 to June 2023, documented in the National Cancer Information Database (NCID).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (age>=18 years) who were newly diagnosed advanced or platinum sensitive recurrence epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and used Olaparib（monotherapy or in combination with Bevacizumab in 1L maintenance setting， or monotherapy in PSR setting） during the study timeframe will be included in the study. Patients will be excluded if they don't have any visit record post use of Olaparib or they were enrolled in the other Olaparib Intensive Monitoring Studies (D0816C00016 and D0817R00011) conducted by AstraZeneca.
Key inclusion criteria (4 listed)
- Patients newly diagnosed with advanced or platinum sensitive recurrence epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (FIGO stage III-IV) treated with Olaparib+/-Bevacizumab according to approved label indications in China;
- Patients with at least one prescription record of Olaparib between August 01, 2018 and June 30, 2023;
- Age ≥18 years at first use of Olaparib;
- At least one visit record after the first use of Olaparib.
Key exclusion criteria (2 listed)
- Patients enrolled in the other Olaparib DIM Programs (D0816C00016 and D0817R00011) conducted by AstraZeneca.
- Patients newly diagnosed with stage I and stage II ovarian cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence, seriousness, and severity of all AEs
Time frame: August 1, 2018 to June 30, 2023.
To assess the safety of Olaparib in Chinese ovarian cancer patients in real-world clinical practice by examining the incidence, seriousness, and severity of all adverse events (AEs), including but not limiting to adverse events of special interest (AESIs), serious adverse events (SAEs), AEs causally related to Olaparib, and AEs leading to dose reduction, interruption, or discontinuation of Olaparib.(classified by 1st Line(1L) 1L Olaparib mono,1L Olaparib +Bevacizumab, Platinum Sensitive Recurrence(PSR) Olaparib mono)
2 secondary outcomes
The number and proportion of patients according to different baseline demographics and characteristics
Time frame: August 1, 2018 to June 30, 2023.
Overall number and proportion of patients with olaprib combination maintenance therapy in PSR patients
Time frame: August 1, 2018 to June 30, 2023.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- D0817R00082\_CSR Synopsis\_RedactedLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingying Wu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE, run by AstraZeneca at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence, seriousness, and severity of all AEs (time frame: August 1, 2018 to June 30, 2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.