Clinical trial · Observational
Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients
Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients Based on "Guideline for Re-examination of New Drugs"
NCT03776123CI-TRIAL-00077541completedClinicalTrials.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 objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Carcinoma | Differentiated Thyroid Gland Carcinoma | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration
- timeFrame
- From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
- measure
- Proportion of patients who had AEs/SAE after Cabometyx™ administration
- timeFrame
- From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
- measure
- Number of AEs/SAEs after Cabometyx™ administration
- timeFrame
- From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Secondary outcomes (2)
- measure
- Objective response rate
- timeFrame
- From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who meet 'Indications' of label for Cabometyx™ as monotherapy * Patients who are treated with Cabometyx™ for the first time according to label for Cabometyx™ as monotherapy * Patients who are aged 18 years or older * Patients who are willing to provide written consent after being informed of this surveillance Exclusion Criteria: * Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label
References
Publications (0)
Data not yet available
No reference posted for this study.