ADCETRIS IV Infusion - Special drug use surveillance (all-case surveillance) Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma
Not Applicable
- Conditions
- Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma
- Registration Number
- JPRN-jRCT1080222405
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
All patients treated with ADCETRIS IV Infusion
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse events<br>Primary timeframeFrom the start of Cycle 1 to the end of Cycle 16 (3 weeks/cycle) or until discontinuation of treatment<br>The frequency of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
- Secondary Outcome Measures
Name Time Method Antitumor efficacy (best response) and overall survival<br>Secondary timeframeFrom the start of Cycle 1 to the end of Cycle 16 (3 weeks/cycle) or until discontinuation of treatment<br>(1) Based on findings from neck, chest, abdominal, and pelvic computed tomography and positron emission tomography, and in accordance with evaluation criteria for antitumor efficacy, the antitumor efficacy (best response) of ADCETRIS will be assessed as one of the following: complete response, unconfirmed complete response (when no PET data are available), partial response, stable disease, or progressive disease.<br>(2) Time to death (regardless of cause of death) will be calculated using Kaplan-Meier method.