Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

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. 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 on or after the first dose of study drug.

The percentage of participants with complete remission (CR) will be calculated based on the modified International Working Group (IWG) criteria for AML.

Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.

Composite Complete Remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol.

Time from date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission (in months).

Time from the date of first oral venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).

Time from the date of first oral venetoclax intake to the date of death from any cause.

Median time to achieve Progression Free Survival (PFS) which is the time from [enrollment or randomization or first dose] to disease progression or death [to the first occurrence of radiographic progression determined by blinded independent central review or death from any cause], whichever occurs first.

Overall Response Rate (ORR) is the proportion of the responders to the total number of participants.