Safety and Efficacy of Lorbrena

Special Investigation for LORBRENA Tablets

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03844464

Enrollment

1290

Registered

2019-02-18

Start date

2019-01-21

Completion date

2025-07-30

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug 1. Factors affecting the onset of central nervous system disorder 2. Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

Inclusion criteria

* All administered patients

Exclusion criteria

* Nothing

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction	52 weeks

Countries

Japan

Outcome results