Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

Incidence of Bone Marrow Suppression

时间窗: Approximately 37 weeks

Incidence of bone marrow suppression including neutropenia (all grades) and febrile neutropenia.

Number of Participants with Dose Interruptions

时间窗: Approximately 37 weeks

Summary data will be collected for participants with dose interruptions.

Incidence of TLS According to Physician Assessment

时间窗: Approximately 37 weeks

Incidence of TLS according to physician assessment.

Incidence of TLS According to Howard Criteria

时间窗: Approximately 37 weeks

Incidence of TLS according to Howard criteria which is a classification system of TLS. Laboratory results must show two or more unusual measurements within a 24-hour period.

Incidence of Adverse Drug Reactions (ADR)

时间窗: Approximately 37 weeks

Adverse drug reactions were defined as AEs of which a causal relationship with venetoclax could not be ruled out. All grades of ADRs will be collected.

Number of Prophylactic Measures Used for TLS

时间窗: Approximately 37 weeks

Number and description of prophylactic measures used in real-world clinical practice for TLS will be collected.

Number of Participants with Dose Modifications

时间窗: Approximately 37 weeks

Summary data will be collected for participants with dose modifications.

Number of Participants Who Discontinued Venetoclax

时间窗: Approximately 37 weeks

Summary data will be collected for participants who discontinued treatment with venetoclax.

Best Overall Response Rate (ORR)

时间窗: Approximately 37 weeks

Defined as complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), nodular partial response (nPR) according to physician assessment based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and Japanese Society of Hematology clinical guidelines.

Time to Best Response

时间窗: Approximately 37 weeks

Time to best response according to physician assessment based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines and Japanese Society of Hematology clinical guidelines.

Overall Incidence of Averse Drug Reactions (ADRs) of Tumor Lysis Syndrome (TLS), Bone Marrow Suppression, and Infections

时间窗: Approximately 37 weeks

Adverse drug reactions were defined as AEs of which a causal relationship with venetoclax could not be ruled out. Overall incidence of ADRs of special interest (TLS, bone marrow suppression, and infections) will be collected.

Incidence of Infections

时间窗: Approximately 37 weeks

Incidence of infections.

Number of Participants With Adverse Events

时间窗: Approximately 37 weeks

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Number of Monitoring Measures Used for TLS

时间窗: Approximately 37 weeks

Number and description of monitoring measures used in real-world clinical practice for TLS will be collected.

Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors

时间窗: Approximately 37 weeks

Incidence of ADRs when venetoclax is used concomitantly with CYP3A inhibitors will be collected.