A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in Japan

Condition(s) studied

Investigational drug(s) / intervention(s)

Tazemetostat: Tazemetostat oral tablets.

Study summary

The primary purpose of the study is to investigate the safety of tazemetostat in participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.

Eligibility

Primary outcome measure(s)

• Number of Participants With Adverse Drug Reactions (ADRs) — Up to Week 52
  An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
• Number of Participants With Serious ADRs — Up to Week 52
  Serious ADRs are defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.

Trial sites (135)

+ 95 more sites — see the full list on the official registry below.

More Eisai Co., Ltd. trials in Japan

Other trials for the same condition