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NCT06324734

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

Completed Last updated 13 June 2025
What this trial tests

trial in 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 in 2,506 participants. Completed in 15 July 2024.

Timeline
29 April 2024
Primary endpoint
15 July 2024
15 July 2024

Quick facts

Lead sponsorAstraZeneca
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2,506
Start date29 April 2024
Primary completion15 July 2024
Estimated completion15 July 2024
Sites1 location across China

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, female only, with 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. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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