Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and bulbar muscular atrophy (SBMA)
Not Applicable
Recruiting
- Conditions
- Spinal and bulbar muscular atrophy
- Registration Number
- JPRN-jRCT1080223924
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
All SBMA patients who have been confirmed as receiving the drug
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants who had One or More Adverse Drug Reactions<br>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.<br>Timeframe; Up to 1 Year<br><br>Percentage of Participants who had One or More Serious Adverse Events<br>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.<br>Timeframe; Up to 1 Year
- Secondary Outcome Measures
Name Time Method