Differentiated Thyroid Carcinoma, Hepatocellular Carcinoma, Renal Cell Carcinoma
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
| Proportion of patients who had AEs/SAE after Cabometyx™ administration | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
| Number of AEs/SAEs after Cabometyx™ administration | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
| Progression Free Survival | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
Countries
South Korea
Outcome results
None listed