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The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition | 1 year |
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Inclusion Criteria:
-The evaluable patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).
Exclusion Criteria:
-No past history of hypersensitivity to the components of Fasenra.
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The patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with 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 | D3250C00057 | Japan | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Akita |
| D3250C00057 |
| Japan |
| Research Site | Aomori | D3250C00057 | Japan |
| Research Site | Chiba | D3250C00057 | Japan |
| Research Site | Ehime | D3250C00057 | Japan |
| Research Site | Fukuoka | D3250C00057 | Japan |
| Research Site | Gunma | D3250C00057 | Japan |
| Research Site | Hiroshima | D3250C00057 | Japan |
| Research Site | Hokkaido | D3250C00057 | Japan |
| Research Site | Hyōgo | D3250C00057 | Japan |
| Research Site | Ibaraki | D3250C00057 | Japan |
| Research Site | Kagawa | D3250C00057 | Japan |
| Research Site | Kagoshima | D3250C00057 | Japan |
| Research Site | Kanagawa | D3250C00057 | Japan |
| Research Site | Kumamoto | D3250C00057 | Japan |
| Research Site | Kyoto | D3250C00057 | Japan |
| Research Site | Mie | D3250C00057 | Japan |
| Research Site | Miyagi | D3250C00057 | Japan |
| Research Site | Numakunai | D3250C00057 | Japan |
| Research Site | Okayama | D3250C00057 | Japan |
| Research Site | Okinawa | D3250C00057 | Japan |
| Research Site | Osaka | D3250C00057 | Japan |
| Research Site | Ōita | D3250C00057 | Japan |
| Research Site | Saitama | D3250C00057 | Japan |
| Research Site | Shiga | D3250C00057 | Japan |
| Research Site | Tochigi | D3250C00057 | Japan |
| Research Site | Tokyo | D3250C00057 | Japan |
| Research Site | Yamagata | D3250C00057 | Japan |
| Research Site | Yamaguchi | D3250C00057 | Japan |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |