Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.

Detailed Description
-----------------
The drug being tested in this survey is called leuprorelin acetate injection kit 11.25 mg. This injection kit is being tested to treat people who have SBMA. This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be approximately 300. This multi-center observational trial will be conducted in Japan.

Official Title
-----------------
Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)

Conditions
-----------------
Spinal and Bulbar Muscular Atrophy

Intervention / Treatment
-----------------
* Drug: Leuprorelin Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All SBMA patients who have been confirmed as receiving the drug Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leuprorelin Acetate 11.25 mg<br>Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care. | Drug: Leuprorelin Acetate<br>* Leuprorelin Acetate Injection Kit<br>* Other names: Leuplin SR for Injection Kit 11.25 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to administered drug. Percentage of participants who have the adverse drug reactions that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported. | Up to 1 Year | 
| Percentage of Participants who had One or More Serious Adverse Events | Percentage of participants who have the serious adverse events that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported. | Up to 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants without Death Event | Percentage of participants without events of death at final assessment point (up to 8 years from initiation of treatment) will be reported. | At final assessment point (up to 8 years) | 
| Percentage of Participants without Pneumonia Requiring Hospitalization Event | Percentage of participants without events of pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported. | At final assessment point (up to 8 years) | 
| Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization | Percentage of participants without composite events of death and pneumonia requiring hospitalization at final assessment point (up to 8 years from initiation of treatment) will be reported. | At final assessment point (up to 8 years) | 
| Percentage of Participants without Dysphagia Events | Percentage of participants without events of dysphagia at final assessment point (up to 8 years from initiation of treatment) will be reported. | At final assessment point (up to 8 years) |