All Patients Treated With the ProductNCT02756039
Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)
An observational study of All Patients Treated With the Product, run by AstraZeneca at 47 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- All Patients Treated With the Product
- How many people
- 3,494 participants
- Where
- 47 sitesJapan
- Study dates
- 25 May 2016to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated with the product will be enrolled in the investigation.
Who may be able to join
- patients treated with the product
Who cannot join
- No Account (NA)
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Research Site
Aichi, D5160C00025
Research Site
Akita, D5160C00025
Research Site
Aomori, D5160C00025
Research Site
Chiba, D5160C00025
Research Site
Ehime, D5160C00025
Research Site
Fukui, D5160C00025
Research Site
Fukuoka, D5160C00025
Research Site
Fukushima, D5160C00025
Research Site
Gifu, D5160C00025
Research Site
Gunma, D5160C00025
Research Site
Hiroshima, D5160C00025
Research Site
Hokkaido, D5160C00025
Research Site
Hyōgo, D5160C00025
Research Site
Ibaraki, D5160C00025
Research Site
Ishikawa, D5160C00025
Research Site
Kagawa, D5160C00025
Research Site
Kagoshima, D5160C00025
Research Site
Kanagawa, D5160C00025
Research Site
Kochi, D5160C00025
Research Site
Kumamoto, D5160C00025
Research Site
Kyoto, D5160C00025
Research Site
Mie, D5160C00025
Research Site
Miyagi, D5160C00025
Research Site
Miyazaki, D5160C00025
Research Site
Nagano, D5160C00025
Research Site
Nagasaki, D5160C00025
Research Site
Nara, D5160C00025
Research Site
Niigata, D5160C00025
Research Site
Numakunai, D5160C00025
Research Site
Ōita, D5160C00025
Research Site
Okayama, D5160C00025
Research Site
Okinawa, D5160C00025
Research Site
Osaka, D5160C00025
Research Site
Saga, D5160C00025
Research Site
Saitama, D5160C00025
Research Site
Shiga, D5160C00025
Research Site
Shimane, D5160C00025
Research Site
Shizuoka, D5160C00025
Research Site
Tochigi, D5160C00025
Research Site
Tokushima, D5160C00025
Research Site
Tokyo, D5160C00025
Research Site
Tottori, D5160C00025
Research Site
Toyama, D5160C00025
Research Site
Wakayama, D5160C00025
Research Site
Yamagata, D5160C00025
Research Site
Yamaguchi, D5160C00025
Research Site
Yamanashi, D5160C00025
About this study
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
- Conditions
- All Patients Treated With the Product
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions (ADRs) in actual clinical use
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start25 May 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Patients Treated With the ProductStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756039
- Sponsor's protocol ID
- D5160C00025
- Status last verified
- Aug 2019
- First submitted
- 28 Apr 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)
- ClinicalTrials.gov ID
- NCT02756039
- Acronym / sponsor ID
- D5160C00025
- Conditions
- All Patients Treated With the Product
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,494 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 May 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated with the product will be enrolled in the investigation.
Key inclusion criteria (1 listed)
- patients treated with the product
Key exclusion criteria (1 listed)
- No Account (NA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Patients Treated With the Product, run by AstraZeneca at 47 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse drug reactions (ADRs) in actual clinical use (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.