RecruitingNot Applicable

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

Japan300 participantsStarted 2022-06-02

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor

Timeframe: 30days

Trial details

NCT IDNCT05454787

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08-31

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Life Threatening Bleeding trials