At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,605 enrolled
Drug / intervention
Afatinib dimaleatedrug
Likely dose
Afatinib dimaleate 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.
In Brief
An observational study evaluating Afatinib dimaleate for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 1,605 participants across 432 sites.
Detailed Summary
In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartMay 2014
Primary CompletionDec 2016
TodayJul 2026
First PostedMay 6, 2014
Enrollment StartMay 7, 2014
Primary CompletionDec 28, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.2 years ago
Interventions
Afatinib dimaleatedrug
20mg - 50mg