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

Drug use-results Survey of Fomepizole Intravenous Infusion "Takeda" as All-Case Surveillance.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080222765

Enrollment

147

Registered

2015-02-24

Start date

2015-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ethylene glycol poisoning, methanol poisoning

Interventions

investigational material(s) Generic name etc : Fomepizole Intravenous Infusion 1.5 g (fomepizole) INN of investigational material : Fomepizole Therapeutic category code : 392 Antidotes Dosage and Adm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who have been confirmed as administration of the drug

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1.Safety: Number of Participants Reporting One or More Adverse Events (AEs) Time frame: 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. 2.Safety: Number of Participants Who Had One or More Adverse Drug Reactions Time Frame: 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. 3.Number of Participants Reporting One or More Serious Adverse Events (SAEs) Time Frame: 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. 4.Number of Participants Who Had One or More Serious Adverse Drug Reactions Time Frame: 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 serio	—

Measure

Time frame

1.Safety: Number of Participants Reporting One or More Adverse Events (AEs) Time frame: 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. 2.Safety: Number of Participants Who Had One or More Adverse Drug Reactions Time Frame: 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. 3.Number of Participants Reporting One or More Serious Adverse Events (SAEs) Time Frame: 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. 4.Number of Participants Who Had One or More Serious Adverse Drug Reactions Time Frame: 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 serio

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026