NCT Number: NCT02756039
Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)
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
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Research Site, Aichi, Japan
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patients treated with the product
Exclusion criteria
- No Account (NA)
Treatment and study plan
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.
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Apr 29, 2016
- Registry last updated
- Aug 28, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.