Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)

Completed

Conditions: Ethylene Glycol Poisoning, Methanol Poisoning

Interventions: Drug: Fomepizole

Registration Number: NCT02415712

Lead Sponsor: Takeda

Brief Summary: The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.

Detailed Description: Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required.

This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g "Takeda," hereinafter referred to as "the drug") was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 147

Inclusion Criteria

-All patients who have been confirmed as receiving the drug

Exclusion Criteria

-None

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fomepizole Intravenous Infusion	Fomepizole	Fomepizole Intravenous Infusion

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Adverse Events (AEs)	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants Who Had One or More Adverse Drug Reactions	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Number of Participants Reporting One or More Serious Adverse Events (SAEs)	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Number of Participants Who Had One or More Serious Adverse Drug Reactions	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
Arterial Blood pH	Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)	pH in arterial blood values at baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) were reported.