Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

Study Overview
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Brief Summary
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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description
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All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
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Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).

Conditions
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Tuberculosis, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)

Intervention / Treatment
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* Drug: rifabutin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients need to be administered Mycobutin® in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Mycobutin®.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rifabutin<br>Patients administered Rifabutin. | Drug: rifabutin<br>* Mycobutin® capsules150mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows.  1.Tuberculosis : The usual adult dosage for oral use is 150 mg to 300 mg of rifabutin once daily.For the treatment of multiple-drug resistance tuberculosis, the usual dosage for oral use is 300 to 450 mg of rifabutin once daily. 2.Treatment of non-tuberculous mycobacterial diseases (including MAC disease) : The usual adult dosage for oral use is 300 mg of rifabutin once daily.<br>* Other names: Mycobutin.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. | 1 year | 
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Mycobutin was assessed by the physician/investigator. | 1 year | 
| Number of Participants With Treatment-Related Adverse Events by Diagnosis | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by diagnosis to assess whether they were risk factors for the treatment related adverse events. | 1 year | 
| Number of Participants With Treatment-Related Adverse Events by Gender | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether they were risk factors for the treatment related adverse events. | 1 year | 
| Number of Participants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to Mycobutin in a participant who received Mycobutin. Relatedness to Mycobutin was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether they were risk factors for the treatment related adverse events. | 1 year | 
| Clinical Efficacy Rate | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. | 1 year | 
| Clinical Efficacy Rate by Diagnosis | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by diagnosis were counted to assess whether they contribute to the clinical effectiveness. | 1 year | 
| Clinical Efficacy Rate by Gender | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by gender were counted to assess whether they contribute to the clinical effectiveness. | 1 year | 
| Clinical Efficacy Rate by Age | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of Mycobutin was assessed as effective, ineffective, or unassessable by the physician/investigator. Overall effectiveness of Mycobutin was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as bacterial values. Participants achieved clinical effectiveness by age were counted to assess whether they contribute to the clinical effectiveness. | 1 year |