A Study of the Safety and Efficacy of Venetoclax in Japanese Participants With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

Primary outcomes

1. Number of Participants With Adverse Events

   Time frame: 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.

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

   Time frame: 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.

3. Incidence of Adverse Drug Reactions (ADR)

   Time frame: 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.

4. Incidence of TLS According to Physician Assessment

   Time frame: Approximately 37 weeks

   Incidence of TLS according to physician assessment.

5. Incidence of TLS According to Howard Criteria

   Time frame: 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.

6. Incidence of Bone Marrow Suppression

   Time frame: Approximately 37 weeks

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

7. Incidence of Infections

   Time frame: Approximately 37 weeks

   Incidence of infections.

8. Incidence of ADRs When Venetoclax is Used Concomitantly with CYP3A Inhibitors

   Time frame: Approximately 37 weeks

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

9. Number of Prophylactic Measures Used for TLS

   Time frame: Approximately 37 weeks

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

10. Number of Monitoring Measures Used for TLS

    Time frame: Approximately 37 weeks

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

11. Number of Participants with Dose Modifications

    Time frame: Approximately 37 weeks

    Summary data will be collected for participants with dose modifications.

12. Number of Participants with Dose Interruptions

    Time frame: Approximately 37 weeks

    Summary data will be collected for participants with dose interruptions.

13. Number of Participants Who Discontinued Venetoclax

    Time frame: Approximately 37 weeks

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

14. Best Overall Response Rate (ORR)

    Time frame: 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.

15. Time to Best Response

    Time frame: 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.