Clinical trial · Observational
Symbenda Post-Marketing Surveillance (PMS)
Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients
NCT02434484CI-TRIAL-00049642completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia | Lymphoid Leukemia | ALIAS | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Symbenda
- description
- Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.
Primary outcomes (1)
- measure
- Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
- timeFrame
- Up to 6 months
- description
- An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Secondary outcomes (3)
- measure
- Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study. This study will be conducted as complete surveillance method; subjects who meet the inclusion/exclusion criteria and administrate Symbenda for the first time after conclusion of agreement will be enrolled. Inclusion Criteria: Patients who meet the following criteria will be eligible for inclusion in the study: 1. Patients with approved indication for Symbenda in Korea 2. Patients who have verbal or written consent for use of personal and medical information for the study purpose Investigators will refer to approved indications and contraindications regarding inclusion criteria. Exclusion Criteria: Investigators will refer to approved indications and contraindications regarding exclusion criteria.
References
Publications (0)
Data not yet available
No reference posted for this study.