Spots Global Cancer Trial Database for Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
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Trial Identification
Brief Title: Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Official Title: Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
Study ID: NCT03445637
Conditions
Interventions
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Pfizer Tower, Seoul, , Korea, Republic of
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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