N/A
Completed N=111
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
Source: ClinicalTrials.gov NCT02156895 ↗Enrolled (actual)
111
Serious AEs
12.6%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) — 92; 79; 14; 7 Participants
Summary
The objective of this study is to monitor the usage of INLYTA® in real practice, including the adverse events associated with INLYTA®.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) |
92; 79; 14; 7 | — |
| PRIMARY Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs |
34; 16; 4; 0 | — |
| PRIMARY Duration of Adverse Events |
28 | — |
| PRIMARY Number of Participants With Adverse Events by Their Severity |
68; 54; 26; 1; 2 | — |
| PRIMARY Number of Participants With Adverse Events by Their Outcome |
61; 1; 38; 23; 12 | — |
| PRIMARY Number of Participants With Adverse Events by Their Seriousness Criteria |
2; 0; 14; 0; 0; 2 | — |
| PRIMARY Number of Participants With Adverse Events by Their Causality to Inlyta |
1; 7; 77; 35; 2; 1 | — |
| PRIMARY Number of Participants With Adverse Events by Their Other Causality |
4; 10; 2; 26 | — |
| PRIMARY Number of Participants With Adverse Events by Their Action Taken With Study Drug |
19; 34; 75; 1; 8 | — |
| PRIMARY Number of Participants With Adverse Events According to Demographic Characteristics |
71; 21; 28; 34; 30; 0 | — |
| PRIMARY Number of Participants With Adverse Events According to Other Baseline Characteristics |
46; 22; 24; 92; 0; 90 | — |
| PRIMARY Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis |
92 | 0.1244 |
| PRIMARY Number of Participants With AEs and ADRs - Special Participant Population |
49; 41; 8; 6; 4; 3 | — |
| PRIMARY Number of Participants With Tumor Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
4; 29; 15; 51; 12 | — |
| PRIMARY Number of Participants With Objective Response |
33 | — |
| PRIMARY Number of Participants With Objective Response According to Demographic Characteristics |
25; 8; 12; 13; 8; 0 | — |
| PRIMARY Number of Participants With Objective Response According to Other Baseline Characteristics |
16; 9; 8; 33; 0; 32 | — |
| PRIMARY Number of Participants With Objective Response - Multivariate Logistic Regression Analysis |
33 | 0.0109 sig |
| PRIMARY Progression Free Survival (PFS) |
232.9 | — |
| PRIMARY Time to Progression (TTP) |
232.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed as advanced RCC after failure of one prior systemic therapy.
Exclusion Criteria
- Any patient who does not agree that Pfizer or companies working on behalf of Pfizer can use his/her information.
- Patients with hypersensitivity to axitinib or to any other component of INLYTA® .
- Patients under 18.
- Pregnant women.
Data sourced from ClinicalTrials.gov (NCT02156895). 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.