N/A
Completed N=1,272
GIOTRIF rPMS in Korean Patients With NSCLC
Source: ClinicalTrials.gov NCT02285361 ↗Enrolled (actual)
1,272
Serious AEs
34.9%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reactions (ADRs) — 89.92 Percentage of participants
Summary
To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs) |
89.92 | — |
| SECONDARY Progression-Free Survival (PFS) Rate at 48 Weeks |
73.74 | — |
| SECONDARY Percentage of Participants With Best Response |
2.90; 60.89; 32.26; 3.22; 0.73 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
Eligibility Criteria
Inclusion criteria
- Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
- Age = 19 years at enrolment
- Patients who have signed on the data release consent form
Exclusion criteria
- Known hypersensitivity to afatinib or any of its excipients
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients for whom GIOTRIF® is contraindicated according to the local label
Data sourced from ClinicalTrials.gov (NCT02285361). 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.