Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02756039

Enrollment

3494

Registered

2016-04-29

Start date

2016-05-25

Completion date

2018-08-31

Last updated

2019-08-28

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

Conditions

All Patients Treated With the Product

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients treated with the product

Exclusion criteria

* No Account (NA)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse drug reactions (ADRs) in actual clinical use	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.

Countries

Japan

Outcome results