NCT02756039CompletedNot Applicable
Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 3,494
- Locations
- 1
- Primary Endpoint
- Incidence of adverse drug reactions (ADRs) in actual clinical use
Study Overview
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.
- Incidence of adverse drug reactions (ADRs) in actual clinical use
- Factors which may affect safety and efficacy of the product (especially analysis of the incidence and risk factors of interstitial lung disease (ILD) events)
- Information of ADRs not expected from "Precautions for Use" of the package insert in Japan
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients treated with the product
Exclusion Criteria
- •No Account (NA)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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