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.
Study Type
OBSERVATIONAL
Enrollment
145
Tazemetostat oral tablets.
Number of Participants With Adverse Drug Reactions (ADRs)
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.
Time frame: Up to Week 52
Number of Participants With Serious ADRs
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.
Time frame: Up to Week 52
Number of Participants With ADRs Based on Participant Background Factors
Number of participants with ADRs such as myelosuppression and infection based on participants background factors will be reported. Participant background factors will be sex, age, height, weight, clinical stage (Ann Arbor classification), the presence or absence of B symptoms, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), complications, past history and history of drug allergy.
Time frame: Up to Week 52
Percentage of Participants with Overall Response
Overall response rate is defined as a percentage of participants who achieved a best response including complete response (CR) or partial response (PR) based on Revised Response Criteria for Malignant Lymphoma (Cheson, 2007). CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Time frame: Up to Week 52
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Eisai Trial Site 131
Komaki-shi, Aichi-ken, Japan
Eisai Trial Site 199
Konan-shi, Aichi-ken, Japan
Eisai Trial Site 21
Nagakute-shi, Aichi-ken, Japan
Eisai Trial Site 106
Nagoya, Aichi-ken, Japan
Eisai Trial Site 156
Nagoya, Aichi-ken, Japan
Eisai Trial Site 174
Nagoya, Aichi-ken, Japan
Eisai Trial Site 91
Nagoya, Aichi-ken, Japan
Eisai Trial Site 170
Okazaki-shi, Aichi-ken, Japan
Eisai Trial Site 181
Seto-shi, Aichi-ken, Japan
Eisai Trial Site 130
Toyohashi, Aichi-ken, Japan
...and 125 more locations