Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)

Completed

• Conditions: All Patients Treated With the Product

• Registration Number: NCT02756039
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Study Start: 2016-05-25
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3494

Inclusion Criteria

• patients treated with the product

Exclusion Criteria

• No Account (NA)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan