Trials / Completed
CompletedNCT03445637
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 552 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS). Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.
Conditions
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2025-07-13
- Completion
- 2025-07-13
- First posted
- 2018-02-26
- Last updated
- 2025-11-24
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03445637. Inclusion in this directory is not an endorsement.