Colorectal Cancer
Conditions
Keywords
Fruzaqla, Fruquintinib, Non-interventional
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.
Interventions
OTHERNo intervention
As this is an observational study, no intervention will be administered.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs | 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 | Up to approximately 6 years |
| Number of Participants with AEs with Grade 3 or Higher | Up to approximately 6 years |
| Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP) | Up to approximately 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) Rate | Up to 6 months | OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla capsule. |
| Progression Free Survival (PFS) Rate | Up to 6 months | PFS rate is the percentage of participants who have not experienced progression or death for 6 months after their start date of Fruzaqla capsule. |
| Objective Response Rate (ORR) | Up to 18 treatment cycles (approximately up to 18 months) | ORR is defined as the percentage of participants achieving a best response of complete response (CR) or partial response (PR). |
| Disease Control Rate (DCR) | Up to 18 treatment cycles (approximately up to 18 months) | DCR is defined as the percentage of participants achieving a best response of CR, PR, or Stable Disease (SD). |
| Median Overall Survival (mOS) | Up to 18 treatment cycles (approximately up to 18 months) | 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. |
| Median Progression Free Survival (mPFS) | Up to 18 treatment cycles (approximately up to 18 months) | 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. |
Countries
South Korea
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed