About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
N/A
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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