Trial Outcomes & Findings for Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance) (NCT NCT02415712)
NCT ID: NCT02415712
Last Updated: 2024-03-04
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
147 participants
Primary outcome timeframe
From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Results posted on
2024-03-04
Participant Flow
Participants took part in the survey at 91 investigative sites in Japan, from 27 January 2015 to 30 June 2022.
Participants with a historical diagnosis of ethylene glycol and methanol poisonings were enrolled. Participants received fomepizole as part of a routine medical care.
Participant milestones
| Measure |
Fomepizole Intravenous Infusion
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Overall Study
STARTED
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147
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Overall Study
COMPLETED
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131
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Overall Study
NOT COMPLETED
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16
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Reasons for withdrawal
| Measure |
Fomepizole Intravenous Infusion
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Overall Study
Protocol Violation
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16
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Baseline Characteristics
The number analyzed is the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
Fomepizole Intravenous Infusion
n=131 Participants
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Age, Continuous
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43.6 Years
STANDARD_DEVIATION 20.65 • n=130 Participants • The number analyzed is the number of participants with data available for analysis.
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Sex: Female, Male
Female
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44 Participants
n=131 Participants
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Sex: Female, Male
Male
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87 Participants
n=131 Participants
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Region of Enrollment
Japan
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131 Participants
n=131 Participants
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Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
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108 Participants
n=131 Participants
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Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
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11 Participants
n=131 Participants
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Predisposition to Hypersensitivity
Unknown
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12 Participants
n=131 Participants
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Medical Complications
Had No Medical Complications
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52 Participants
n=131 Participants
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Medical Complications
Had Medical Complications
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78 Participants
n=131 Participants
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Medical Complications
Unknown
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1 Participants
n=131 Participants
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Medical History
Had No Medical History
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94 Participants
n=131 Participants
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Medical History
Had Medical History
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33 Participants
n=131 Participants
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Medical History
Unknown
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4 Participants
n=131 Participants
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Height
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162.9 Centimeters (cm)
STANDARD_DEVIATION 14.01 • n=115 Participants • The number analyzed is the number of participants with data available for analysis.
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Weight
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60.99 Kilograms (kg)
STANDARD_DEVIATION 16.752 • n=123 Participants • The number analyzed is the number of participants with data available for analysis.
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BMI
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22.71 Kilogram (kg)/meter (m)^2
STANDARD_DEVIATION 4.780 • n=115 Participants • The number analyzed is the number of participants with data available for analysis.
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Alcohol Consumption (at Time of Poisoning)
No
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80 Participants
n=131 Participants
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Alcohol Consumption (at Time of Poisoning)
Yes
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27 Participants
n=131 Participants
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Alcohol Consumption (at Time of Poisoning)
Unknown
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24 Participants
n=131 Participants
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Pregnancy Status
Not Pregnant
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42 Participants
n=44 Participants • The number analyzed is the number of participants with data available for analysis.
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Pregnancy Status
Pregnant
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0 Participants
n=44 Participants • The number analyzed is the number of participants with data available for analysis.
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Pregnancy Status
Unknown
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2 Participants
n=44 Participants • The number analyzed is the number of participants with data available for analysis.
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PRIMARY outcome
Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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.
Outcome measures
| Measure |
Fomepizole Intravenous Infusion
n=131 Participants
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Number of Participants Reporting One or More Adverse Events (AEs)
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22 Participants
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PRIMARY outcome
Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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.
Outcome measures
| Measure |
Fomepizole Intravenous Infusion
n=131 Participants
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Number of Participants Who Had One or More Adverse Drug Reactions
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7 Participants
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PRIMARY outcome
Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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.
Outcome measures
| Measure |
Fomepizole Intravenous Infusion
n=131 Participants
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Number of Participants Reporting One or More Serious Adverse Events (SAEs)
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13 Participants
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PRIMARY outcome
Timeframe: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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.
Outcome measures
| Measure |
Fomepizole Intravenous Infusion
n=131 Participants
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Number of Participants Who Had One or More Serious Adverse Drug Reactions
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0 Participants
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PRIMARY outcome
Timeframe: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)Population: Participants in the Efficacy Analysis Set for whom test value/s from at least one assessment time point is/are available from both before and after the start of fomepizole intravenous infusion.
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.
Outcome measures
| Measure |
Fomepizole Intravenous Infusion
n=91 Participants
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Arterial Blood pH
Baseline
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7.3010 pH
Standard Deviation 0.16064
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Arterial Blood pH
4 Hours after the First Dose
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7.4042 pH
Standard Deviation 0.06809
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Arterial Blood pH
24 Hours after the Last Dose
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7.4120 pH
Standard Deviation 0.05078
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Adverse Events
Fomepizole Intravenous Infusion
Serious events: 13 serious events
Other events: 3 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Fomepizole Intravenous Infusion
n=131 participants at risk
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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Metabolism and nutrition disorders
Acidosis
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Nervous system disorders
Cerebral haemorrhage
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Nervous system disorders
Depressed level of consciousness
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Nervous system disorders
Brain oedema
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Nervous system disorders
Putamen haemorrhage
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Cardiac disorders
Arrhythmia
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Gastrointestinal disorders
Intestinal ischaemia
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Hepatobiliary disorders
Liver disorder
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Renal and urinary disorders
Acute kidney injury
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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General disorders
Death
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1.5%
2/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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General disorders
Multiple organ dysfunction syndrome
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Investigations
Blood pressure decreased
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Injury, poisoning and procedural complications
Alcohol poisoning
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0.76%
1/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Injury, poisoning and procedural complications
Chemical poisoning
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1.5%
2/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Other adverse events
| Measure |
Fomepizole Intravenous Infusion
n=131 participants at risk
The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
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|---|---|
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Gastrointestinal disorders
Vomiting
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2.3%
3/131 • From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER