N/A
Completed N=147
Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)
Ethylene Glycol Poisoning, Methanol Poisoning
Source: ClinicalTrials.gov NCT02415712 ↗
Enrolled (actual)
147
Serious AEs
9.9%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Events (AEs) — 22 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Events (AEs) |
22 | — |
| PRIMARY Number of Participants Who Had One or More Adverse Drug Reactions |
7 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Events (SAEs) |
13 | — |
| PRIMARY Number of Participants Who Had One or More Serious Adverse Drug Reactions |
— | — |
| PRIMARY Arterial Blood pH |
7.3010; 7.4042; 7.4120 | — |
Eligibility Criteria
Inclusion Criteria
-All patients who have been confirmed as receiving the drug
Exclusion Criteria
-None
Data sourced from ClinicalTrials.gov (NCT02415712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.