N/A
N=1,602
Long-term Observation PMS for Afatinib
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT02131259 ↗Enrolled (actual)
1,602
Serious AEs
70.5%
Results posted
Sep 2018
Primary outcome: Primary: Incidence of Adverse Drug Reactions (ADRs) — 95.19 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Afatinib dimaleate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Drug Reactions (ADRs) |
95.19 | — |
| SECONDARY Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1] |
40.07 | — |
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).
Eligibility Criteria
Inclusion criteria
- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC)will be included.
Exclusion criteria
- None
Data sourced from ClinicalTrials.gov (NCT02131259). 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.