Anaemetro I.V. Infusion 500mg Drug Use Investigation

Study Overview
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Brief Summary
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Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice

Official Title
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METRONIDAZOLE IV DRUG USE INVESTIGATION

Conditions
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Anaerobic Infection, Infectious Enterocolitis, Amebic Dysentery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study. Exclusion Criteria: No exclusion criteria are set out in this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reaction (ADR) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician. | Maximum 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Rate | Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. | Maximum 8 weeks | 
| Clinical Response Rates by Target Diseases | Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Participants assessed as effective by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery. | Maximum 8 weeks |