Special drug use surveillance of Leuplin PRO for Injection Kit 22.5 mg for Prostate cancer
Not Applicable
- Conditions
- Prostate cancer
- Registration Number
- JPRN-jRCT1080223158
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 333
Inclusion Criteria
Participants with prostate cancer will be included.
Exclusion Criteria
Participants who meet the following criteria will not be included.
-Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants who had one or more adverse events<br><br>Time frame is defined the duration from the start of treatment with Leuprorelin acetate injection up to 24 weeks after the start of treatment (or at the time the observation is discontinued).<br>Timeframe: Up to Week 24
- Secondary Outcome Measures
Name Time Method Percentage of participants who had one or more adverse drug reactions<br><br>Adverse drug reaction refers to adverse events related to administered drug. Time frame is defined the duration from the start of treatment with Leuprorelin acetate injection up to 24 weeks after the start of treatment (or at the time the observation is discontinued).<br>Timeframe: Up to Week 24