All Patients Treated With the Product Clinical Trial
Official title:
Tagrisso Tablets Clinical Experience Investigation (All Case Investigation)
| NCT number | NCT02756039 |
| Other study ID # | D5160C00025 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 25, 2016 |
| Est. completion date | August 31, 2018 |
| Verified date | August 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 3494 |
| Est. completion date | August 31, 2018 |
| Est. primary completion date | August 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - patients treated with the product Exclusion Criteria: - No Account (NA) |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Aichi | |
| Japan | Research Site | Akita | |
| Japan | Research Site | Aomori | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Ehime | |
| Japan | Research Site | Fukui | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukushima | |
| Japan | Research Site | Gifu | |
| Japan | Research Site | Gunma | |
| Japan | Research Site | Hiroshima | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ishikawa | |
| Japan | Research Site | Iwate | |
| Japan | Research Site | Kagawa | |
| Japan | Research Site | Kagoshima | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kochi | |
| Japan | Research Site | Kumamoto | |
| Japan | Research Site | Kyoto | |
| Japan | Research Site | Mie | |
| Japan | Research Site | Miyagi | |
| Japan | Research Site | Miyazaki | |
| Japan | Research Site | Nagano | |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Nara | |
| Japan | Research Site | Niigata | |
| Japan | Research Site | Oita | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Saga | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shimane | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Tochigi | |
| Japan | Research Site | Tokushima | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tottori | |
| Japan | Research Site | Toyama | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Yamagata | |
| Japan | Research Site | Yamaguchi | |
| Japan | Research Site | Yamanashi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 12 months |