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 Type
OBSERVATIONAL
Enrollment
600
As this is an observational study, no intervention will be administered.
Yonsei University Hospital
Seoul, South Korea
RECRUITINGNumber 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
Overall Survival (OS) Rate
OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla capsule.
Time frame: Up to 6 months
Progression Free Survival (PFS) Rate
PFS rate is the percentage of participants who have not experienced progression or death for 6 months after their start date of Fruzaqla capsule.
Time frame: Up to 6 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants achieving a best response of complete response (CR) or partial response (PR).
Time frame: Up to 18 treatment cycles (approximately up to 18 months)
Disease Control Rate (DCR)
DCR is defined as the percentage of participants achieving a best response of CR, PR, or Stable Disease (SD).
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Time frame: Up to 18 treatment cycles (approximately up to 18 months)
Median Overall Survival (mOS)
OS will be defined as the time from the start date of Fruzaqla to the date of death from any cause. The mOS is the time at which 50% of participants are expected to have died from any cause.
Time frame: Up to 18 treatment cycles (approximately up to 18 months)
Median Progression Free Survival (mPFS)
PFS will be defined as the time from the start date of Fruzaqla capsule to the date of documented progression or death from any cause. Tumor assessment will be performed by routine clinical practice of the investigators. The mPFS is the time at which 50% of participants are expected to have experienced disease progression or died from any cause.
Time frame: Up to 18 treatment cycles (approximately up to 18 months)