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This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.
"Safety specification" Thrombotic events, Infusion reaction, re-bleeding
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor | Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor | 30days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated with this drug to neutralize the anticoagulant effect of a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) at onset of a life-threatening bleeding episode or a unarrestable bleeding episode.
The patients treated with direct acting Factor Xa inhibitors (apixaban, rivaroxaban or edoxaban tosilate hydrate) to neutralize anticoagulation effect at the time of life threatening bleeding or uncontrolled bleeding during the period of ethical free provision of the drug ( from the date of market authorization to the date of NHI drug price listing ) are also included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| Toshimitsu Tokimoto | Astrazeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Withdrawn | Aichi | Japan | |||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 Pharma 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 anonymized individual patient-level data via secure research environment Vivli Org.
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Recruiting |
| Aichi |
| Japan |
| Research Site | Withdrawn | Akita | Japan |
| Research Site | Withdrawn | Aomori | Japan |
| Research Site | Withdrawn | Chiba | Japan |
| Research Site | Active, not recruiting | Chiba | Japan |
| Research Site | Active, not recruiting | Ehime | Japan |
| Research Site | Withdrawn | Ehime | Japan |
| Research Site | Withdrawn | Fukui | Japan |
| Research Site | Active, not recruiting | Fukui | Japan |
| Research Site | Withdrawn | Fukuoka | Japan |
| Research Site | Active, not recruiting | Fukuoka | Japan |
| Research Site | Withdrawn | Fukushima | Japan |
| Research Site | Withdrawn | Gifu | Japan |
| Research Site | Active, not recruiting | Gifu | Japan |
| Research Site | Withdrawn | Gunma | Japan |
| Research Site | Active, not recruiting | Gunma | Japan |
| Research Site | Recruiting | Gunma | Japan |
| Research Site | Withdrawn | Hiroshima | Japan |
| Research Site | Withdrawn | Hokkaido | Japan |
| Research Site | Active, not recruiting | Hokkaido | Japan |
| Research Site | Withdrawn | Hyōgo | Japan |
| Research Site | Withdrawn | Ibaraki | Japan |
| Research Site | Withdrawn | Ishikawa | Japan |
| Research Site | Withdrawn | Kagawa | Japan |
| Research Site | Withdrawn | Kagoshima | Japan |
| Research Site | Withdrawn | Kanagawa | Japan |
| Research Site | Withdrawn | Kochi | Japan |
| Research Site | Withdrawn | Kumamoto | Japan |
| Research Site | Active, not recruiting | Kumamoto | Japan |
| Research Site | Withdrawn | Kyoto | Japan |
| Research Site | Withdrawn | Mie | Japan |
| Research Site | Withdrawn | Miyagi | Japan |
| Research Site | Withdrawn | Miyazaki | Japan |
| Research Site | Withdrawn | Nagano | Japan |
| Research Site | Active, not recruiting | Nagano | Japan |
| Research Site | Withdrawn | Nagasaki | Japan |
| Research Site | Recruiting | Nagasaki | Japan |
| Research Site | Withdrawn | Nara | Japan |
| Research Site | Withdrawn | Niigata | Japan |
| Research Site | Active, not recruiting | Niigata | Japan |
| Research Site | Withdrawn | Numakunai | Japan |
| Research Site | Withdrawn | Okayama | Japan |
| Research Site | Withdrawn | Okinawa | Japan |
| Research Site | Withdrawn | Osaka | Japan |
| Research Site | Withdrawn | Saga | Japan |
| Research Site | Withdrawn | Saitama | Japan |
| Research Site | Withdrawn | Shiga | Japan |
| Research Site | Withdrawn | Shimane | Japan |
| Research Site | Withdrawn | Shizuoka | Japan |
| Research Site | Withdrawn | Tochigi | Japan |
| Research Site | Active, not recruiting | Tochigi | Japan |
| Research Site | Withdrawn | Tokushima | Japan |
| Research Site | Withdrawn | Tokyo | Japan |
| Research Site | Active, not recruiting | Tokyo | Japan |
| Research Site | Active, not recruiting | Tottori | Japan |
| Research Site | Withdrawn | Toyama | Japan |
| Research Site | Withdrawn | Wakayama | Japan |
| Research Site | Active, not recruiting | Wakayama | Japan |
| Research Site | Withdrawn | Yamagata | Japan |
| Research Site | Withdrawn | Yamaguchi | Japan |
| Research Site | Withdrawn | Yamanashi | Japan |