Symbenda Post-Marketing Surveillance (PMS)

Eisai

Status: Completed

Conditions: Multiple Myeloma; Lymphocytic Leukemia; Lymphoma, Non-Hodgkin

Study type: Observational

Funder types: Industry

Identifiers

NCT02434484

B0501-M065-501

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

84 participants in 1 patient group

Symbenda

Description:

Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.