Last reviewed · How we verify

NCT02756039

Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)

Completed Last updated 28 August 2019
What this trial tests

trial in All Patients Treated With the Product in 3,494 participants. Completed in 31 August 2018.

Timeline
25 May 2016
Primary endpoint
31 August 2018
31 August 2018

Quick facts

Lead sponsorAstraZeneca
StatusCompleted
Study typeOBSERVATIONAL
Enrollment3,494
Start date25 May 2016
Primary completion31 August 2018
Estimated completion31 August 2018
Sites47 locations across Japan

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Eligibility, any sex, with All Patients Treated With the Product. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan.
    Ohe Y, Kato T, Sakai F, Kusumoto M, et al · · 2020 · cited 24× · PMID 32548617 · DOI 10.1093/jjco/hyaa067

Verify or expand the search:

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02756039.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing