Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ovarian Cancer
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The study will recruit about 1,500 Chinese cancer patients from around 30 sites who received at least one dose of olaparib treatment before study enrolment in real world practice in approved tumor types.The recruited patients will be followed up according to standard clinical practice. They will be ...
The study will recruit about 1,500 Chinese cancer patients from around 30 sites who received at least one dose of olaparib treatment before study enrolment in real world practice in approved tumor types.The recruited patients will be followed up according to standard clinical practice. They will be tracked up to 30 days after discontinuation of olaparib treatment, or 8 months after enrolment if treatment continues. The primary objective of this study is to describe the safety and tolerability of olaparib in Chinese patients by assessing the incidence, seriousness, causality, severity and action taken (interruption/dose reduction/discontinuation) of all AEs (including adverse events of special interest [AESIs]).
Tracking Information
- NCT #
- NCT04560452
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Zhongqliu Lin Sun Yat-sen Memorial Hospital,Sun Yat-sen University