N/A
Completed N=13
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
Source: ClinicalTrials.gov NCT02533258 ↗Enrolled (actual)
13
Serious AEs
15.4%
Results posted
Oct 2017
Primary outcomePrimary: Duration of Axitinib Treatment — 15.2 months
Summary
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Axitinib Treatment |
15.2 | — |
| PRIMARY Mean Daily Dose of Axitinib |
9.24 | — |
| SECONDARY Objective Response Rate (ORR) |
7.69 | — |
| SECONDARY Duration of Response |
1 | — |
| SECONDARY Progression-Free Survival (PFS) |
32.73 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
11; 2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) by Severity |
5; 3; 3; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events (AEs) |
8 | — |
| SECONDARY Number of Participants Discontinued Due to Adverse Events (AEs) |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed as advanced RCC by histology or cytology
- Patients using axitinib as therapy after failure of sunitinib or cytokine
- Patients received axitinib treatment and follow up in the health care center participating present registry
- Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available
Exclusion Criteria
- Patients with first dose of axitinib earlier than 7th May 2013
- Patients with first dose of axitinib later than 30th June 2015.
- Patients participating in clinical research involving axitinib
- Patients with hypersensitivity to axitinib or to any other component of axitinib
- Patients under 18-year of age
- Pregnant women.
Data sourced from ClinicalTrials.gov (NCT02533258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.