Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)

August 22, 2019 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, D5160C00025
        • Research Site
      • Akita, Japan, D5160C00025
        • Research Site
      • Aomori, Japan, D5160C00025
        • Research Site
      • Chiba, Japan, D5160C00025
        • Research Site
      • Ehime, Japan, D5160C00025
        • Research Site
      • Fukui, Japan, D5160C00025
        • Research Site
      • Fukuoka, Japan, D5160C00025
        • Research Site
      • Fukushima, Japan, D5160C00025
        • Research Site
      • Gifu, Japan, D5160C00025
        • Research Site
      • Gunma, Japan, D5160C00025
        • Research Site
      • Hiroshima, Japan, D5160C00025
        • Research Site
      • Hokkaido, Japan, D5160C00025
        • Research Site
      • Hyogo, Japan, D5160C00025
        • Research Site
      • Ibaraki, Japan, D5160C00025
        • Research Site
      • Ishikawa, Japan, D5160C00025
        • Research Site
      • Iwate, Japan, D5160C00025
        • Research Site
      • Kagawa, Japan, D5160C00025
        • Research Site
      • Kagoshima, Japan, D5160C00025
        • Research Site
      • Kanagawa, Japan, D5160C00025
        • Research Site
      • Kochi, Japan, D5160C00025
        • Research Site
      • Kumamoto, Japan, D5160C00025
        • Research Site
      • Kyoto, Japan, D5160C00025
        • Research Site
      • Mie, Japan, D5160C00025
        • Research Site
      • Miyagi, Japan, D5160C00025
        • Research Site
      • Miyazaki, Japan, D5160C00025
        • Research Site
      • Nagano, Japan, D5160C00025
        • Research Site
      • Nagasaki, Japan, D5160C00025
        • Research Site
      • Nara, Japan, D5160C00025
        • Research Site
      • Niigata, Japan, D5160C00025
        • Research Site
      • Oita, Japan, D5160C00025
        • Research Site
      • Okayama, Japan, D5160C00025
        • Research Site
      • Okinawa, Japan, D5160C00025
        • Research Site
      • Osaka, Japan, D5160C00025
        • Research Site
      • Saga, Japan, D5160C00025
        • Research Site
      • Saitama, Japan, D5160C00025
        • Research Site
      • Shiga, Japan, D5160C00025
        • Research Site
      • Shimane, Japan, D5160C00025
        • Research Site
      • Shizuoka, Japan, D5160C00025
        • Research Site
      • Tochigi, Japan, D5160C00025
        • Research Site
      • Tokushima, Japan, D5160C00025
        • Research Site
      • Tokyo, Japan, D5160C00025
        • Research Site
      • Tottori, Japan, D5160C00025
        • Research Site
      • Toyama, Japan, D5160C00025
        • Research Site
      • Wakayama, Japan, D5160C00025
        • Research Site
      • Yamagata, Japan, D5160C00025
        • Research Site
      • Yamaguchi, Japan, D5160C00025
        • Research Site
      • Yamanashi, Japan, D5160C00025
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients treated with the product will be enrolled in the investigation.

Description

Inclusion Criteria:

  • patients treated with the product

Exclusion Criteria:

  • No Account (NA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions (ADRs) in actual clinical use
Time Frame: Up to 12 months
Presence/absence of adverse events (AEs) [any undesirable or unintentional signs (including laboratory abnormalities), symptoms, or diseases whether or not considered causally related to the product] reported during the observation period However, deterioration of a pre-existing lung cancer lesion and lung cancer death should not be reported as an AE.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2016

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • D5160C00025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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