A postmarketing all patient surveillance of Romiplate for s.c. injectio
Not Applicable
- Conditions
- Chronic idiopathic thrombocytopenic purpura(chronic ITP)
- Registration Number
- JPRN-UMIN000047864
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 2077
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment: 1. Occurrence of ADRs / infectations (e.g., types and incidence) 2. Identifying factors that may affect the safety 3. Occurrence of serious adverse events 4. Examining primary investigation items Efficacy assessment: 1. Transition of platelet count 2. Identifying factors that may affect transition of platelet count
- Secondary Outcome Measures
Name Time Method