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The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.
This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ADRs | the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders | 156 weeks |
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Inclusion Criteria:
Exclusion Criteria:
None
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The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy)
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| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | AstraZeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aichi | Japan | ||||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA P harma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| Akita |
| Japan |
| Research Site | Aomori | Japan |
| Research Site | Chiba | Japan |
| Research Site | Fukui | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Gifu | Japan |
| Research Site | Gunma | Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Hokkaido | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Ishikawa | Japan |
| Research Site | Kagawa | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Mie | Japan |
| Research Site | Miyagi | Japan |
| Research Site | Nara | Japan |
| Research Site | Numakunai | Japan |
| Research Site | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Saitama | Japan |
| Research Site | Shimane | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | Tochigi | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Wakayama | Japan |
| Research Site | Yamagata | Japan |
| Research Site | Yamaguchi | Japan |
| Research Site | Yamanashi | Japan |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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