Clinical trial · Observational
Long-term Observation PMS for Afatinib
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib dimaleate | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Afatinib
- interventionNames
- Drug: Afatinib dimaleate
Primary outcomes (1)
- measure
- Incidence of Adverse Drug Reactions (ADRs)
- timeFrame
- From first drug administration until 28 days after the last drug administration, up to 52 weeks.
- description
- This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
Secondary outcomes (1)
- measure
- Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
- timeFrame
- 52 weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available