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Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)

NCT02756039 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3494

Last updated 2019-08-28

No results posted yet for this study

Summary

Clinical experience investigation (CEI) is to be conducted to confirm the following to characterise safety and efficacy of Tagrisso Tablets in actual clinical use.

1. Incidence of adverse drug reactions (ADRs) in actual clinical use
2. Factors which may affect safety and efficacy of the product (especially analysis of the incidence and risk factors of interstitial lung disease (ILD) events)
3. Information of ADRs not expected from "Precautions for Use" of the package insert in Japan

Conditions

  • All Patients Treated With the Product

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-25
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02756039 on ClinicalTrials.gov