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Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting

CompletedN/A

Sponsor: AstraZeneca

Conditions: 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

Countries: China

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Beijing, Beijing Municipality, China