A Study Evaluating Venetoclax in Combination With Low-Dos... | NCT02287233

ID	Type	Description	Link
2014-002610-23	EudraCT Number

Name	Class
Genentech, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Phase 1: 600 mg Venetoclax + LDAC	Experimental	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.	Drug: Venetoclax Drug: Cytarabine
Phase 1: 800 mg Venetoclax + LDAC	Experimental	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.	Drug: Venetoclax Drug: Cytarabine
Phase 2: 600 mg Venetoclax + LDAC	Experimental	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Name	Type	Description	Arm Group Labels	Other Names
Venetoclax	Drug	Venetoclax will be taken orally once daily.	Phase 1: 600 mg Venetoclax + LDAC Phase 1: 800 mg Venetoclax + LDAC Phase 2: 600 mg Venetoclax + LDAC

Measure	Description	Time Frame
Phase 1: Number of Participants With Dose-limiting Toxicities	Dose-limiting toxicities (DLTs) were determined during cycle 1 of the dose-escalation phase and defined as Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 grade 4 (life threatening requiring urgent intervention) or 5 (resulted in death) toxicity, excluding adverse events commonly caused by AML (eg, neutropenia, fever). Hematologic DLT was defined as failure of platelet recovery to 25 × 10^9/L or greater and absolute neutrophil count (ANC) to 0.5 × 10^9/L or greater within 14 days of the last dose of venetoclax in the absence of residual AML.	Up to 28 days (Cycle 1)
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax	The highest concentration that a drug achieves in the blood after administration in a dosing interval.	Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax	The time at which the maximum plasma concentration (Cmax) is observed.	Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)
Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax		Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Cytarabine	The highest concentration that a drug achieves in the blood after administration in a dosing interval.

Measure	Description	Time Frame
Complete Remission Rate	Complete remission (CR) rate is defined as the percentage of participants who achieved a complete remission at any time point during the study per the modified IWG criteria for AML and investigator assessment. CR: absolute neutrophil count (ANC) ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, red blood cell (RBC) transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts. Participants who never achieved CR or had no IWG disease assessment were considered to be non-responders in the calculation of CR rate.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must be greater than or equal to 65 years of age in Phase 1 and 2. Participants enrolled in Cohort C must be either:
- greater than or equal to 75 years of age; OR
- greater than or equal to 60 to 74 years will be eligible if the participants has at least one of the following co-morbidities, which make the participant unfit for intensive chemotherapy:
  - Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 - 3;
  - Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction less than or equal to 50% or chronic stable angina;
  - Diffusion capacity of carbon monoxide (DLCO) less than or equal to 65% or forced expiratory volume in one second (FEV1) less than or equal to 65%;
  - Creatinine clearance greater than or equal to 30 mL/min to less than 45 ml/min (calculated by Cockcroft-Gault formula)
  - Moderate hepatic impairment with total bilirubin greater than 1.5 to less than or equal to 3.0 × upper limit of normal (ULN)
  - Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the study medical monitor before study enrollment
Participant must have a projected life expectancy of at least 12 weeks.
Participant must have histological confirmation of AML and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
Participant must have received no prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Participant may have been treated for prior Myelodysplastic Syndrome.
Participant must have an ECOG performance status:
- of 0 to 2 for participants greater than equal to 75 years of age
- of 0 to 3 for participants greater than equal to 60 to 74 years of age, if 0 - 1 another co-morbidity is required to make participant eligible.
Participant must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
Participant must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) less than or equal to 2.5 × ULN
- alanine aminotransferase (ALT) less than or equal to 2.5 × ULN
- bilirubin less than or equal to 1.5 × ULN for all participants age 75 and older
  - Participants who are less than 75 years of age must have a bilirubin of less than 3.0 × ULN.

Note: Participants with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion between the investigator and AbbVie medical monitor.

Male participants must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 180 days after the last dose of study drug.
Participant must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
If female, participant must be either:
- Postmenopausal defined as no menses for 12 or more months without an alternative medical cause OR
- Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)

Exclusion Criteria:

Participant has received treatment with cytarabine for a pre-existing myeloid disorder.
Participant has acute promyelocytic leukemia (French-American-British Class M3 AML).
Participant has known active central nervous system (CNS) involvement with AML.
Participant has tested positive for human immunodeficiency virus (HIV).
Participant has received the following within 7 days prior to the initiation of study treatment:
- Strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
Participant has a cardiovascular disability status of New York Heart Association Class greater than 2.
Participant has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
Participant has chronic respiratory disease that requires continuous oxygen use.
Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
Participant exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled systemic infection requiring intravenous (IV) therapy (viral, bacterial or fungal).
Participant has a history of other malignancies prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the breast or cervix uteri;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Participant has a white blood cell count greater than 25 × 10^9/L. Note: Hydroxyurea is permitted to meet this criterion.
Participant is a candidate for a bone marrow or stem cell transplant within 12 weeks after study enrollment.
Participant has a history of myeloproliferative neoplasm (MPN) including polycythemia vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia.

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ Kansas Med Ctr /ID# 131175		Kansas City	Kansas	66160	United States
Weill Cornell Medical College /ID# 131170

PubMed Identifier	Type	Citation	Retractions
30892988	Background	Wei AH, Strickland SA Jr, Hou JZ, Fiedler W, Lin TL, Walter RB, Enjeti A, Tiong IS, Savona M, Lee S, Chyla B, Popovic R, Salem AH, Agarwal S, Xu T, Fakouhi KM, Humerickhouse R, Hong WJ, Hayslip J, Roboz GJ. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J Clin Oncol. 2019 May 20;37(15):1277-1284. doi: 10.1200/JCO.18.01600. Epub 2019 Mar 20.
41269778

Label	URL
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.	View source

ID	Title	Description
FG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 22, 2020	Aug 3, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Phase 1: Number of Participants With Dose-limiting Toxicities

Dose-limiting toxicities (DLTs) were determined during cycle 1 of the dose-escalation phase and defined as Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 grade 4 (life threatening requiring urgent intervention) or 5 (resulted in death) toxicity, excluding adverse events commonly caused by AML (eg, neutropenia, fever). Hematologic DLT was defined as failure of platelet recovery to 25 × 10^9/L or greater and absolute neutrophil count (ANC) to 0.5 × 10^9/L or greater within 14 days of the last dose of venetoclax in the absence of residual AML.

The DLT-evaluable population included participants who received at least 80% of planned Cycle 1 doses during the dose-escalation phase (Phase 1)

Posted

Count of Participants

Participants

Up to 28 days (Cycle 1)

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Units	Counts
Participants	OG0008 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011

Primary

Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax

The highest concentration that a drug achieves in the blood after administration in a dosing interval.

Participants enrolled in Phase 1 who had at least one dose of venetoclax and had at least one reported pharmacokinetic (PK) sample concentration.

Posted

Mean

Standard Deviation

µg/mL

Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Primary

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax

The time at which the maximum plasma concentration (Cmax) is observed.

Participants enrolled in Phase 1 who had at least one dose of venetoclax and had at least one reported PK sample concentration

Posted

Median

Full Range

hours

Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Primary

Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax

Participants enrolled in Phase 1 who had at least one dose of venetoclax and had at least one reported PK sample concentration with available data at each time point

Posted

Mean

Standard Deviation

µg*h/mL

Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Primary

Phase 1: Maximum Observed Plasma Concentration (Cmax) of Cytarabine

The highest concentration that a drug achieves in the blood after administration in a dosing interval.

Participants enrolled in Phase 1 who had at least one dose of cytarabine and had at least one reported PK sample concentration.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose.

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Primary

Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Cytarabine

The time at which the maximum plasma concentration (Cmax) is observed.

Participants enrolled in Phase 1 who had at least one dose of cytarabine and had at least one reported PK sample concentration.

Posted

Median

Full Range

hours

Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose.

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Primary

Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to Last Measurable Concentration (AUCt) of Cytarabine

Participants enrolled in Phase 1 who had at least one dose of cytarabine and had at least one reported PK sample concentration.

Posted

Mean

Standard Deviation

ng*h/mL

Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose.

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
OG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.

Primary

Overall Response Rate

Overall response rate (ORR) is defined as the percentage of participants who achieved a complete remission (CR), complete remission with incomplete marrow recovery (CRi), or partial remission (PR) per the International Working Group (IWG) for AML response criteria, per investigator assessment.

CR: absolute neutrophil count (ANC) ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, red blood cell (RBC) transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRi: lack of morphologic evidence of leukemia (blasts < 5%), and platelet counts < 10^5 /µL or ANC < 10^3 /µL.

PR: all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg). Efficacy endpoints were pre-specified for Phase 2 only, and are reported for all participants who received the RPTD.

Posted

Number

95% Confidence Interval

percentage of participants

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator rated the severity of each AE according to the CTCAE Version 4.0 and the following:

Grade 1: The AE is transient and easily tolerated (mild).

Grade 2: The AE causes discomfort and interrupts usual activities (moderate).

Grade 3: The AE causes considerable interference with usual activities and may be incapacitating (moderate to severe).

Grade 4: The AE is life threatening requiring urgent intervention.

Grade 5: The AE resulted in death.

The investigator assessed each event as either having a reasonable possibility or no reasonable possibility of being related to the use of study drug.

Treatment-emergent events are defined as events that began or worsened in severity after the first dose of study drug.

All enrolled participants who received at least one dose of study drug

Posted

Count of Participants

Participants

From first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.

ID	Title	Description
OG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Complete Remission Rate

Complete remission (CR) rate is defined as the percentage of participants who achieved a complete remission at any time point during the study per the modified IWG criteria for AML and investigator assessment.

Participants who never achieved CR or had no IWG disease assessment were considered to be non-responders in the calculation of CR rate.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units

Secondary

Complete Remission Plus CR With Incomplete Blood Count Recovery (CRi) Rate

The percentage of participants who achieved a CR or CRi at any time point during the study per the modified IWG criteria for AML and investigator assessment.

CRi: lack of morphologic evidence of leukemia (blasts < 5%), and platelet counts < 10^5 /µL or ANC < 10^3 /µL

Participants who never achieved CR or CRi or had no IWG disease assessment were considered to be non-responders in the calculation of CR + CRi rate.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

CR Plus CRi Rate by Initiation of Cycle 2

The percentage of participants who achieved a CR or CRi by initiation of Cycle 2 of study treatment per the modified IWG criteria for AML and investigator assessment.

CR: ANC ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRi: Lack of morphologic evidence of leukemia (blasts < 5%), and platelet counts < 10^5 /µL or ANC < 10^3 /µL.

Participants who never achieved CR or CRi or had no IWG disease assessment by initiation of Cycle 2 were considered to be non-responders in the calculation of CR + CRi rate by initiation of Cycle 2.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

Cycle 2, Day 1

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts

Secondary

Time to First Response of CR + CRi

The time to the first response of CR + CRi is defined as the time from the first date of study drug to the first response of CR or CRi per the IWG AML response criteria assessed by the investigator.

CR: absolute neutrophil count (ANC) ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRi: lack of morphologic evidence of leukemia (blasts < 5%), and platelet counts < 10^5 /µL or ANC < 10^3 /µL.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRi

Posted

Median

Full Range

months

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts

Secondary

Time to Best Response of CR + CRi

The time to the best response of CR + CRi is defined as the time from the first date of study drug to the best response of CR or CRi per the IWG AML response criteria assessed by the investigator.

CRi: lack of morphologic evidence of leukemia (blasts < 5%), and platelet counts < 10^5 /µL or ANC < 10^3 /µL.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRi

Posted

Median

Full Range

months

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts

Secondary

Complete Remission With Partial Hematologic Recovery (CRh) Rate

Complete remission with partial hematologic recovery is a derived response based on bone marrow blast and hematology laboratory values. CRh rate is defined as the percentage of participants who achieved CRh as the best response at any time point during the study.

A participant achieved a CRh when meeting the following criteria:

Bone marrow with < 5% blasts and
Peripheral blood neutrophil count of > 0.5 × 10^3 /µL and
Peripheral blood platelet count of > 0.5 × 10^5 /µL and
A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection.

Participants who never achieved CRh or did not have disease assessment or hematology data were considered to be non-responders in the calculation of CRh rate.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

CR Plus CRh Rate

CR + CRh rate is defined as the percentage of participants who achieved CR or CRh at any time point during the study.

CR: ANC ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRh is a derived response based on bone marrow blast and hematology lab values. A participant achieved a CRh when meeting the following criteria:

Bone marrow with < 5% blasts and
Peripheral blood neutrophil count of > 0.5 × 10^3 /µL and
Peripheral blood platelet count of > 0.5 × 10^5 /µL and
A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection.

Participants who never achieved CR/CRh or did not have disease assessment or hematology data were considered to be non-responders in the calculation of CR + CRh rate.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

CR Plus CRh Rate by Initiation of Cycle 2

CR + CRh rate by initiation of Cycle 2 is defined as the percentage of participants who achieved CR or CRh by initiation of Cycle 2 of study treatment.

CR: ANC ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRh is a derived response based on bone marrow blast and hematology lab values. A participant achieved a CRh when meeting the following criteria:

Bone marrow with < 5% blasts and
Peripheral blood neutrophil count of > 0.5 × 10^3 /µL and
Peripheral blood platelet count of > 0.5 × 10^5 /µL and
A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection.

Participants who never achieved CR/CRh or did not have disease assessment by initiation of Cycle 2 were considered to be non-responders in the calculation of CR + CRh rate by initiation of Cycle 2.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

Cycle 2, Day 1

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Time to First Response of CR Plus CRh

The time to the first response of CR + CRh is defined as the time from the first date of study drug to the first response of CR or CRh.

CR: ANC ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRh is a derived response based on bone marrow blast and hematology lab values. A participant achieved a CRh when meeting the following criteria:

Bone marrow with < 5% blasts and
Peripheral blood neutrophil count of > 0.5 × 10^3 /µL and
Peripheral blood platelet count of > 0.5 × 10^5 /µL and
A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRh

Posted

Median

Full Range

months

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Time to Best Response of CR Plus CRh

The time to the best response of CR + CRh is defined as the time from the first date of study drug to the best response of CR or CRh.

CR: ANC ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence (a period of at least 56 days with no RBC transfusion), and bone marrow with < 5% blasts.

CRh is a derived response based on bone marrow blast and hematology lab values. A participant achieved a CRh when meeting the following criteria:

Bone marrow with < 5% blasts and
Peripheral blood neutrophil count of > 0.5 × 10^3 /µL and
Peripheral blood platelet count of > 0.5 × 10^5 /µL and
A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRh

Posted

Median

Full Range

months

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Best Response Based on IWG Criteria

Best response determined using the IWG-AML response criteria during the course of treatment.

CR: ANC ≥ 10^3 /µL, platelet counts ≥ 10^5 /µL, RBC transfusion independence, and bone marrow with < 5% blasts;
CRi: lack of morphologic evidence of leukemia (blasts < 5%), and platelet counts < 10^5 /µL or ANC < 10^3 /µL;
PR: all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate;
MLFS: < 5% blasts in an aspirate and/or bone marrow core sample;
RD: failure to achieve CR, CRi, PR; only including subjects surviving at least 7 days following completion of initial treatment cycle with evidence of persistent leukemia by blood and/or bone marrow examination;
PD: one or more of the following: ≥ 50% decrement from maximum response levels in neutrophils or platelets; a reduction in hemoglobin by at least 2 g/dL; or transfusion dependence not due to other toxicities and bone marrow blast ≥ 5%.

All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Count of Participants

Participants

Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Duration of Complete Response

Duration of CR is defined as the time from date that a participant achieved CR to the first date of relapse, clinical disease progression or death due to disease progression, whichever occurred earliest. Duration of CR was estimated using Kaplan-Meier methodology. If a participant was still responding at the data cutoff date, then the participant's data were censored at their last disease assessment date. Disease assessment data after the onset of any post-treatment therapy were not included in the duration of CR analysis.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR

Posted

Median

95% Confidence Interval

months

Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts
Participants

Secondary

Duration of CR Plus CRi

Duration of CR + CRi is defined as the time from the date that a participant achieved CR or CRi to the first date of relapse, clinical disease progression or death due to disease progression, whichever occurred earliest. Duration of CR + CRi was estimated using Kaplan-Meier methodology. If a participant was still responding at the data cutoff date, then the participant's data were censored at their last disease assessment date. Disease assessment data after the onset of any post-treatment therapy were not included in the analysis.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRi

Posted

Median

95% Confidence Interval

months

Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts
Participants

Secondary

Duration of CRi

Duration of CRi is defined as the time from date that a participant achieved CRi to the first date of relapse, clinical disease progression or death due to disease progression, whichever occurred earliest. Duration of CRi was estimated using Kaplan-Meier methodology. If a participant was still responding at the data cutoff date, then the participant's data were censored at their last disease assessment date. Disease assessment data after the onset of any post-treatment therapy were not included in the analysis.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CRi

Posted

Median

95% Confidence Interval

months

Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts
Participants

Secondary

Duration of CR Plus CRh

Duration of CR + CRh is defined as the time from date that a participant achieved CR or CRh to the first date of relapse, clinical disease progression or death due to disease progression, whichever occurred earliest. Duration of CR + CRh was estimated using Kaplan-Meier methodology. If a participant was still responding at the data cutoff date, then the participant's data were censored at their last disease assessment date. Disease assessment data after the onset of any post-treatment therapy were not included in the analysis.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) with a response of CR or CRh

Posted

Median

95% Confidence Interval

months

Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts
Participants

Secondary

Overall Survival (OS)

Overall survival is defined as the time from the date of first dose to the date of death. All events of death were included, regardless of whether the event occurred while the participant was still taking study drug, or after the participant discontinued study drug. OS was estimated using Kaplan-Meier methodology. Participants who were still alive were censored at the analysis date.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Median

95% Confidence Interval

months

Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Units	Counts
Participants

Secondary

Post Baseline Transfusion Independence Rate

Post baseline transfusion independence rate was estimated as the percentage of participants who achieved transfusion independence during the evaluation period. Post-baseline transfusion independence is defined as a period of at least 56 days (≥ 56 days) with no RBC or platelet transfusion during the evaluation period. The evaluation period is from the first dose of study drug to the last dose of study drug until the 30 day follow-up visit, disease progression (including clinical progression), or death, whichever was earlier.

Results are reported for participants who achieved both RBC and platelet transfusion independence and for participants who received RBC transfusion independence and platelet transfusion independence.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)

Posted

Number

95% Confidence Interval

percentage of participants

From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months.

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Post Baseline Transfusion Independence Rate Among Participants Transfusion-dependent at Baseline

Results are reported for participants who achieved both RBC and platelet transfusion independence and for participants who received RBC transfusion independence and platelet transfusion independence.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) who received a RBC or platelet transfusion within 8 weeks prior to first dose (60), an RBC transfusion within 8 weeks prior to first dose (53) or a platelet transfusion within 8 weeks prior to first dose (23).

Posted

Number

95% Confidence Interval

percentage of participants

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Secondary

Duration of Post Baseline Transfusion Independence

The duration of transfusion independence is defined as the first time period that a participant received no RBC/platelet transfusions for at least 56 days during the evaluation period.

Post-baseline transfusion independence is defined as a period of at least 56 days with no RBC or platelet transfusion during the evaluation period. The evaluation period is from the first dose of study drug to the last dose of study drug until the 30 day follow-up visit, disease progression (including clinical progression), or death, whichever was earlier.

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) who achieved post-baseline RBC or platelet transfusion independence overall (50), RBC and platelet transfusion independence (37), RBC transfusion independence (39), or platelet transfusion independence (48).

Posted

Median

Full Range

days

ID	Title	Description
OG000	Phase 1+2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0022 events1 affected74 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0015 events3 affected10 at risk EG00234 events22 affected74 at risk
HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0026 events2 affected74 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
BRADYCARDIA	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DIPLOPIA	Eye disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0022 events2 affected74 at risk
COLITIS	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
INTUSSUSCEPTION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
LARGE INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
VOMITING	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ASTHENIA	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
DEATH	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DEVICE RELATED THROMBOSIS	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DISEASE PROGRESSION	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
GAIT DISTURBANCE	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HYPERPYREXIA	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
PYREXIA	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0014 events4 affected10 at risk EG0022 events2 affected74 at risk
SUDDEN DEATH	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ACUTE HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
BACTERAEMIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
CANDIDA PNEUMONIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0020 events0 affected74 at risk
CELLULITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
COVID-19	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
CYSTITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
DIVERTICULITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0023 events3 affected74 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0028 events2 affected74 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
LARGE INTESTINE INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
NOSOCOMIAL INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PARAINFLUENZAE VIRUS INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PNEUMONIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0011 events1 affected10 at risk EG00214 events11 affected74 at risk
PNEUMONIA KLEBSIELLA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
PULMONARY SEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
RESPIRATORY TRACT INFECTION FUNGAL	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
SEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00210 events8 affected74 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
SERRATIA SEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
UPPER RESPIRATORY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0023 events2 affected74 at risk
UROSEPSIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
VASCULAR DEVICE INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
INTENTIONAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
POST-TRAUMATIC PAIN	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
AMYLASE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
LIPASE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
TROPONIN INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
MALIGNANT NEOPLASM PROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected10 at risk EG0025 events5 affected74 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
DEMENTIA	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HEADACHE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
LACUNAR INFARCTION	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
LETHARGY	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PRESYNCOPE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
SYNCOPE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DYSURIA	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PULMONARY ALVEOLAR HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0022 events1 affected74 at risk
HYPERTENSION	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
HYPOTENSION	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0006 events5 affected8 at risk EG0012 events2 affected10 at risk EG00272 events19 affected74 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG00213 events12 affected74 at risk
HYPOFIBRINOGENAEMIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0024 events2 affected74 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG00010 events4 affected8 at risk EG0015 events4 affected10 at risk EG00225 events19 affected74 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0004 events4 affected8 at risk EG00111 events4 affected10 at risk EG00244 events26 affected74 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0028 events6 affected74 at risk
BRADYCARDIA	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0010 events0 affected10 at risk EG0023 events2 affected74 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0029 events6 affected74 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0026 events6 affected74 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
ERYTHEMA OF EYELID	Eye disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
EYE PAIN	Eye disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
RETINAL HAEMORRHAGE	Eye disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
VISION BLURRED	Eye disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0023 events3 affected74 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events1 affected10 at risk EG00217 events11 affected74 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0025 events4 affected74 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events2 affected8 at risk EG0013 events3 affected10 at risk EG00230 events27 affected74 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events6 affected8 at risk EG0014 events2 affected10 at risk EG00261 events34 affected74 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0023 events3 affected74 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0027 events6 affected74 at risk
ERUCTATION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0022 events2 affected74 at risk
GASTROINTESTINAL PAIN	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
LIP ULCERATION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
MOUTH HAEMORRHAGE	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0010 events0 affected10 at risk EG0028 events6 affected74 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0026 events6 affected74 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG00013 events8 affected8 at risk EG00112 events6 affected10 at risk EG00267 events48 affected74 at risk
ODYNOPHAGIA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
PARAESTHESIA ORAL	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0027 events6 affected74 at risk
TONGUE HAEMATOMA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
TRICHOGLOSSIA	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
VOMITING	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0004 events3 affected8 at risk EG0015 events3 affected10 at risk EG00230 events21 affected74 at risk
CATHETER SITE INFLAMMATION	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
CATHETER SITE PAIN	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0023 events2 affected74 at risk
CHEST DISCOMFORT	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0026 events6 affected74 at risk
CHEST PAIN	General disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0023 events3 affected74 at risk
CHILLS	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG00213 events6 affected74 at risk
DEVICE RELATED THROMBOSIS	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
FATIGUE	General disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events7 affected8 at risk EG00111 events3 affected10 at risk EG00252 events28 affected74 at risk
INJECTION SITE HAEMATOMA	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
MALAISE	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0026 events6 affected74 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0029 events8 affected74 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events2 affected10 at risk EG0024 events4 affected74 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (24.0)	Systematic Assessment	EG0005 events2 affected8 at risk EG0012 events2 affected10 at risk EG00218 events13 affected74 at risk
PAIN	General disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0029 events9 affected74 at risk
PYREXIA	General disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events1 affected8 at risk EG0011 events1 affected10 at risk EG00215 events14 affected74 at risk
BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
CELLULITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0025 events5 affected74 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
HORDEOLUM	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0027 events5 affected74 at risk
PARONYCHIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
PNEUMONIA	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0026 events5 affected74 at risk
SIALOADENITIS	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0024 events4 affected74 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0029 events7 affected74 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected10 at risk EG0022 events2 affected74 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0029 events7 affected74 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0026 events4 affected74 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
PERIORBITAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events1 affected10 at risk EG0024 events4 affected74 at risk
SUNBURN	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
TOOTH FRACTURE	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG00214 events8 affected74 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0015 events1 affected10 at risk EG0029 events7 affected74 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00210 events8 affected74 at risk
BLOOD ALBUMIN DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00213 events4 affected74 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00227 events10 affected74 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0014 events2 affected10 at risk EG00233 events19 affected74 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0017 events1 affected10 at risk EG00218 events8 affected74 at risk
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
BLOOD URIC ACID INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
HEART RATE IRREGULAR	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00211 events8 affected74 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
LYMPHOCYTE COUNT DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG002116 events15 affected74 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00292 events14 affected74 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG002152 events20 affected74 at risk
PROTHROMBIN TIME PROLONGED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
SPECIFIC GRAVITY URINE DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
TROPONIN INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
WEIGHT DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0026 events6 affected74 at risk
WEIGHT INCREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0023 events3 affected74 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0012 events2 affected10 at risk EG002170 events28 affected74 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events5 affected8 at risk EG0012 events2 affected10 at risk EG00232 events25 affected74 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0013 events3 affected10 at risk EG0024 events3 affected74 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0013 events1 affected10 at risk EG00212 events9 affected74 at risk
HYPERMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00211 events10 affected74 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0027 events7 affected74 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00228 events10 affected74 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG00261 events22 affected74 at risk
HYPOCHLORAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0024 events2 affected74 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0005 events4 affected8 at risk EG0015 events3 affected10 at risk EG00277 events36 affected74 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0014 events3 affected10 at risk EG00244 events27 affected74 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG00248 events16 affected74 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events2 affected8 at risk EG0011 events1 affected10 at risk EG00241 events22 affected74 at risk
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0022 events2 affected74 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0013 events3 affected10 at risk EG00220 events12 affected74 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0012 events2 affected10 at risk EG00216 events14 affected74 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
CHONDROCALCINOSIS PYROPHOSPHATE	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events2 affected10 at risk EG0023 events3 affected74 at risk
LIMB MASS	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0024 events3 affected74 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0025 events4 affected74 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events3 affected8 at risk EG0011 events1 affected10 at risk EG0024 events4 affected74 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0013 events3 affected10 at risk EG00213 events11 affected74 at risk
CEREBRAL MICROANGIOPATHY	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
DIZZINESS	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events2 affected8 at risk EG0011 events1 affected10 at risk EG00218 events11 affected74 at risk
HEADACHE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0004 events3 affected8 at risk EG0012 events2 affected10 at risk EG00224 events20 affected74 at risk
LETHARGY	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0022 events2 affected74 at risk
PARAESTHESIA	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
RESTLESS LEGS SYNDROME	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
SINUS HEADACHE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
SOMNOLENCE	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
TASTE DISORDER	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
TREMOR	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
ANXIETY	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00211 events11 affected74 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events3 affected8 at risk EG0010 events0 affected10 at risk EG0027 events7 affected74 at risk
DELIRIUM	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
DEPRESSION	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG00211 events10 affected74 at risk
FLAT AFFECT	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
HALLUCINATION, VISUAL	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
INSOMNIA	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG00217 events17 affected74 at risk
MOOD ALTERED	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
PROCEDURAL ANXIETY	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
RESTLESSNESS	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events2 affected8 at risk EG0013 events3 affected10 at risk EG00210 events6 affected74 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0023 events3 affected74 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG00224 events19 affected74 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG00233 events20 affected74 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0023 events3 affected74 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0012 events2 affected10 at risk EG00212 events9 affected74 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0027 events7 affected74 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0024 events4 affected74 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG00210 events9 affected74 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events2 affected8 at risk EG0012 events1 affected10 at risk EG00210 events10 affected74 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG0024 events4 affected74 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0024 events4 affected74 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk
RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0010 events0 affected10 at risk EG0026 events6 affected74 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
NAIL DISCOLOURATION	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG00214 events7 affected74 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0010 events0 affected10 at risk EG00211 events10 affected74 at risk
PURPURA	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0028 events7 affected74 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0022 events2 affected74 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0021 events1 affected74 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0025 events5 affected74 at risk
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0020 events0 affected74 at risk
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0022 events2 affected74 at risk
STASIS DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected8 at risk EG0011 events1 affected10 at risk EG0021 events1 affected74 at risk
HAEMATOMA	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0011 events1 affected10 at risk EG0022 events2 affected74 at risk
HYPERTENSION	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events1 affected8 at risk EG0011 events1 affected10 at risk EG00219 events14 affected74 at risk
HYPOTENSION	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected8 at risk EG0013 events2 affected10 at risk EG00214 events12 affected74 at risk
MACROANGIOPATHY	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected8 at risk EG0010 events0 affected10 at risk EG0020 events0 affected74 at risk

ID	Term
D015470	Leukemia, Myeloid, Acute
D007951	Leukemia, Myeloid

ID	Term
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description
BG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
BG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
BG002	Phase 2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.	6	8	7	8	8	8
EG001	Phase 1: 800 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.	10	10	9	10	10	10
EG002	Phase 2: 600 mg Venetoclax + LDAC	Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.	63	76	68	74	74	74