Clinical trial · Observational
Regulatory TYKERB® Tablets PMS
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of TYKERB® Tablets Administered in Korean Patients According to the Prescribing Information
- 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)
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TYKERB® tablets | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- TYKERB® tablets
- description
- There is only one group. This group includes patients administrated TYKERB® tablets
- interventionNames
- Drug: TYKERB® tablets
Primary outcomes (1)
- measure
- Occurrence of adverse events after TYKERB® tablets administration
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation: * Subjects with indication in the locally approved prescribing information * Subjects with no contraindication according to the prescribing information
References
Publications (0)
Data not yet available