Study identifier:D9603C00001
ClinicalTrials.gov identifier:NCT05454787
EudraCT identifier:N/A
CTIS identifier:N/A
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All case investigation)
life threatening bleeding
N/A
No
-
All
300
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jul 2025 by AstraZeneca
AstraZeneca
-
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. 1) Detection of unknown adverse drug reactions 2) Incidence of adverse drug reactions under actual use conditions of the drug 3) Factors that may affect the safety or effectiveness "Safety specification" Thrombotic events, Infusion reaction, re-bleeding
Location
Status
Location
Miyagi, Japan
Status
Active, not recruiting
Location
Fukushima, Japan
Status
Active, not recruiting
Location
Ibaraki, Japan
Status
Active, not recruiting
Location
Chiba, Japan
Status
Active, not recruiting
Location
Tokyo, Japan
Status
Active, not recruiting
Location
Kanagawa, Japan
Status
Active, not recruiting
Location
Fukui, Japan
Status
Active, not recruiting
Location
Nagano, Japan
Status
Active, not recruiting
Arms | Assigned Interventions |
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