Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)

AstraZeneca

Status: Enrolling

Conditions: Life Threatening Bleeding; Factor Xa Inhibitor

Study type: Observational

Funder types: Industry

Identifiers

NCT05454787

D9603C00001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• N/A