Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

Pfizer1 site in 1 country552 target enrollmentFebruary 8, 2018

ConditionsBreast Neoplasm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Neoplasm
Sponsor: Pfizer
Enrollment: 552
Locations: 1
Primary Endpoint: Treatment-related adverse events during first 3 months
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 8, 2018

End Date

July 13, 2025

Last Updated

5 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Treatment-related adverse events during first 3 months

Time Frame: 2018 ~ 2025

This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.