Clinical trial · Observational
Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The incidence, seriousness, and severity of all AEs
- timeFrame
- August 1, 2018 to June 30, 2023.
- description
- 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)
Secondary outcomes (2)
- measure
- The number and proportion of patients according to different baseline demographics and characteristics
- timeFrame
- August 1, 2018 to June 30, 2023.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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; 2. Patients with at least one prescription record of Olaparib between August 01, 2018 and June 30, 2023; 3. Age ≥18 years at first use of Olaparib; 4. At least one visit record after the first use of Olaparib. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available