Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
Study Overview
Brief Summary
The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of fruquintinib among adult participants who have been administered fruquintinib as per the approved indications.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater than or equal to (>=)18 years.
- •Participants who are initiate treatment or will be treated with Fruzaqla according to the approved label of South Korea.
- •Participant voluntarily consent to participate in the study.
- •Exclusion criteria:
- •Participants for whom Fruzaqla is contraindicated or those with risks that should avoid starting Fruzaqla, as per the product label.
- •Participants actively participating in other interventional clinical trial(s) on mCRC treatments.
- •Pregnant or breastfeeding women.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
Time Frame: Up to approximately 6 years
Number of Participants with Any Serious Adverse Events (SAEs), Serious Adverse Drug Reaction (SADRs), Expected and Unexpected SAEs and SADRs, AEs Leading to Death
Time Frame: Up to approximately 6 years
Number of Participants with AEs with Grade 3 or Higher
Time Frame: Up to approximately 6 years
Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP)
Time Frame: Up to approximately 6 years
Secondary Outcomes
- Objective Response Rate (ORR)(Up to 18 treatment cycles (approximately up to 18 months))
- Overall Survival (OS) Rate(Up to 6 months)
- Progression Free Survival (PFS) Rate(Up to 6 months)
- Disease Control Rate (DCR)(Up to 18 treatment cycles (approximately up to 18 months))
- Median Overall Survival (mOS)(Up to 18 treatment cycles (approximately up to 18 months))
- Median Progression Free Survival (mPFS)(Up to 18 treatment cycles (approximately up to 18 months))