N/A
N=292
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02139592 ↗Enrolled (actual)
292
Serious AEs
34.2%
Results posted
May 2019
Primary outcome: Primary: Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) — 238; 97 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Brentuximab vedotin (recombinant) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) |
238; 97 | — |
| SECONDARY Percentage of Participants Who Achieve or Maintain Any Best Response |
64.9; 36.5; 67.6; 57.1 | — |
| SECONDARY Overall Survival (OS) |
82.7; 79.3 | — |
Summary
The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.
Eligibility Criteria
Inclusion Criteria
- All patients treated with brentuximab vedotin IV Infusion
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02139592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.