EPKINLY Subcutaneous Injection General use-results surveillance (All case): OBSC3013-39D-E
Not Applicable
Recruiting
- Conditions
- Relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma
- Registration Number
- JPRN-jRCT2031230525
- Lead Sponsor
- Genmab K.K. Drug safety and pharmacovigilance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
All patients treated with EPKINLY
Exclusion Criteria
none
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenia, tumor lysis syndrome, and progressive multifocal leukoencephalopathy in post-marketing clinical use.
- Secondary Outcome Measures
Name Time Method 1: The timing of CRS onset. <br>2: The rate of CRS preventive measures. <br>3: The compliance with CRS and ICANS management guidance. <br>4: The incidence of all adverse events and adverse drug reactions that occurred in clinical use. <br>Overall response rate as determined by Lugano Response Criteria for Malignant Lymphoma (2014)