Clinical trial · Observational
A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea
Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
NCT07035886CI-TRIAL-00104207recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Study Participants
- description
- Data will be collected for participants with metastatic colorectal cancer (mCRC) who will receive Fruzaqla according to the approved indication as per the Physician's routine schedule.
- interventionNames
- Other: No intervention
Primary outcomes (4)
- measure
- Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
- timeFrame
- Up to approximately 6 years
- measure
- Number of Participants with Any Serious Adverse Events (SAEs), Serious Adverse Drug Reaction (SADRs), Expected and Unexpected SAEs and SADRs, AEs Leading to Death
- timeFrame
- Up to approximately 6 years
- measure
- Number of Participants with AEs with Grade 3 or Higher
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.