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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003900-30 | EudraCT Number | ||
| 2024-513630-37-00 | Other Identifier | EU CT |
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The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).
Acute myeloid leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the patient has, and the age of the patient when diagnosed.
Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to cytarabine works better than cytarabine on its own.
This is a Phase 3, randomized, double-blind (treatment unknown to patients and doctors), placebo-controlled, multicenter study in patients with AML who are 18 or more years old and have not been treated before. Patients who take part in this study should not be suitable for intensive induction chemotherapy (usual starting treatment). Abbvie is funding this study which will take place at approximately 125 hospitals globally. In this study, 2/3 of patients will receive venetoclax every day with cytarabine and the remaining 1/3 will receive placebo (dummy) tablets with cytarabine.
Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax + Low Dose Cytarabine (LDAC) | Experimental | Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
| Placebo + LDAC | Placebo Comparator | Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | tablet |
| |
| Venetoclax |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) | The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML: CR: No morphologic evidence of AML and absolute neutrophil count (ANC) ≥ 10³/μL (1,000/μL), platelets ≥ 10⁵/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, the CRi criteria are met. Participants who had no IWG disease assessments were considered to be non-responders. |
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Inclusion Criteria:
Participant must have histological confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, be ineligible for intensive induction chemotherapy and either be:
≥ 75 years of age OR
≥ 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy:
Participant must have an ECOG performance status:
Participant must have a projected life expectancy of at least 12 weeks.
Participant must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
Participant must have adequate liver function as demonstrated by:
aspartate aminotransferase (AST) ≤ 3.0 × ULN*
alanine aminotransferase (ALT) ≤ 3.0 × ULN*
bilirubin ≤ 1.5 × ULN*
(*Unless considered to be due to leukemic organ involvement.)
Female participants must be either postmenopausal defined as:
OR
OR
Male participants who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
Females of childbearing potential must have negative results for pregnancy test performed:
Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion Criteria:
Participant has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for myelodysplastic syndrome is allowed except for use of cytarabine.
Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL 1 translocation and AML with BCR-ABL 1 translocation.
Participants that have acute promyelocytic leukemia (APL).
Participant has known central nervous system (CNS) involvement with AML.
Participant has known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). HIV testing will be performed at Screening, if required per local guidelines or institutional standards.
Participant is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded.
Participant has received strong or moderate cytochrome P450 3A4 (CYP3A) inducers 7 days prior to the initiation of study treatment.
Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the initiation of study treatment.
Participant has cardiovascular disability status of New York Heart Association Class > 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain. Class 3 is defined as cardiac disease which subjects are comfortable at rest but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4 is defined as cardiac disease which subjects have an inability to carry on any physical activity without discomfort, symptoms of heart failure at rest, and if any physical activity is undertaken then discomfort increases.
Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.
Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
Participant has a history of other malignancies prior to study entry, with the exception of:
Participant has a white blood cell count > 25 × 10^9/L. (Note: hydroxyurea administration or leukapheresis is permitted to meet this criterion).
Previous treatment with venetoclax and/or current participation in any other research study with investigational products.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffit Cancer Center /ID# 164273 | Tampa | Florida | 33612 | United States | ||
| Norton Cancer Institute /ID# 158998 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32219442 | Background | Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, Kim I, Stevens DA, Fiedler W, Pagoni M, Samoilova O, Hu Y, Anagnostopoulos A, Bergeron J, Hou JZ, Murthy V, Yamauchi T, McDonald A, Chyla B, Gopalakrishnan S, Jiang Q, Mendes W, Hayslip J, Panayiotidis P. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020 Jun 11;135(24):2137-2145. doi: 10.1182/blood.2020004856. | |
| 41269778 |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants with acute myeloid leukemia (AML) were randomized to one of two treatment arms in a 1:2 ratio (placebo + low-dose cytarabine [LDAC] or venetoclax + LDAC). Randomization was stratified by AML status (secondary, de novo), age (18 - < 75, ≥ 75) and region (United States [US], European Union [EU], China, Japan, rest of world).
Participants were enrolled at 76 sites globally. The study is currently ongoing; the results reported below include the primary analysis for efficacy which was conducted after 133 deaths occurred (data cut-off date of 15 February 2019), and an unplanned 6-month follow-up update for overall survival and safety (15 August 2019 cut-off date).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Low Dose Cytarabine (LDAC) | Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2019 | Feb 6, 2020 |
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| Drug |
tablet |
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| Cytarabine | Drug | Subcutaneous injection |
|
|
| Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) | The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) at any time point during the study assessed by the investigator. CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is a derived response based on bone marrow blast and hematology lab values, achieved when the following criteria are met:
Participants with no disease assessments were considered to be non-responders. | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2 | The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML: CR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met. Participants who had no IWG disease assessments were considered to be non-responders. | Cycle 1, 28 days |
| Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2 | The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) before initiation of Cycle 2 assessed by the investigator. CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is a derived response based on bone marrow blast and hematology lab values, achieved when when the following criteria are met:
Participants with no disease assessments were considered to be non-responders. | Cycle 1, 28 days |
| Percentage of Participants With Complete Remission | The complete remission rate is defined as the percentage of participants with complete remission (CR) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML. CR is defined as no morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Participants who had no IWG disease assessments were considered to be non-responders. | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a | PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points. | Baseline and Day 1 of Cycles 3, 5, 7, and 9 |
| Change From Baseline in Global Health Status / Quality of Life | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting). The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life. | Baseline and Day 1 of Cycles 3, 5, 7, and 9 |
| Event-free Survival (EFS) | Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria. PD:
Participants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy. | From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. |
| Percentage of Participants With Post Baseline Red Blood Cell (RBC) Transfusion Independence | The post baseline red blood cell (RBC) transfusion independence rate was calculated as the percentage of participants who achieved RBC transfusion independence post baseline. RBC transfusion independence is defined as a period of at least 56 consecutive days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier. | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
| Percentage of Participants With Post Baseline Platelet Transfusion Independence | The post baseline platelet transfusion independence rate was calculated as the percentage of participants who achieved platelet transfusion independence post Baseline. Platelet transfusion independence is defined as a period of at least 56 consecutive days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut--off date, whichever occurred earlier. | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
| Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline | The rate of conversion was calculated as the percentage of participants who were post-baseline RBC transfusion independent among participants who had an RBC transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). RBC transfusion independence is defined as a period of at least 56 days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier. | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
| Percentage of Participants With Platelet Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline | The rate of conversion was calculated as the percentage of participants who were post-baseline platelet transfusion independent among participants who had a platelet transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). Platelet transfusion independence is defined as a period of at least 56 days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier. | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
| Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response | The percentage of participants with complete remission or complete remission with incomplete blood count recovery AND minimal residual disease (MRD) as assessed by the investigator. Response was based on the modified IWG response criteria for AML: CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria are met. MRD response (at lowest-point MRD value) was defined as having less than 10-³ residual blasts per leukocyte measured in the bone marrow, per European LeukemiaNet (ELN) recommendations. Participants who had no disease or MRD assessments were considered to be non-responders. | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) and Minimal Residual Disease (MRD) Response | The percentage of participants with complete remission or complete remission with partial hematologic recovery (CRh) AND MRD response as assessed by the investigator. CR is defined according to the modified IWG response criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is achieved when the following criteria are met:
MRD response (at lowest-point MRD value) was defined as less than 10-³ residual blasts per leukocyte measured in the bone marrow, per ELN recommendations. Participants who had no disease or MRD assessments were considered to be non-responders. | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Overall Survival (OS) by Mutation Subgroups | Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. Overall survival was analyzed in participants with the following molecular markers:
| From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. |
| Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Mutation Subgroup | Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML: CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria is met. Participants who had no IWG disease assessments were considered to be non-responders. Response was analyzed in participants with the following mutations:
| Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup | The percentage of participants who achieved a complete remission or complete remission with partial hematologic recovery assessed by the investigator for participants with the following mutations:
CR is defined according to the modified IWG criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is achieved when the following criteria are met:
| Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
| Louisville |
| Kentucky |
| 40202-3700 |
| United States |
| Univ of Pittsburgh Med Ctr /ID# 158997 | Pittsburgh | Pennsylvania | 15232 | United States |
| Univ TX, MD Anderson /ID# 159678 | Houston | Texas | 77030 | United States |
| Swedish Medical Center /ID# 161280 | Seattle | Washington | 98104 | United States |
| Gundersen Health System /ID# 164272 | La Crosse | Wisconsin | 54601 | United States |
| Cemic /Id# 159676 | Buenos Aires | 1431 | Argentina |
| Sanatorio Allende /ID# 159675 | Córdoba | 5000 | Argentina |
| Calvary Mater Newcastle /ID# 160123 | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital /ID# 160121 | Westmead | New South Wales | 2145 | Australia |
| Alfred Hospital /ID# 160125 | Melbourne | Victoria | 3004 | Australia |
| Box Hill Hospital /ID# 162920 | Melbourne | Victoria | 3128 | Australia |
| Universitair Ziekenhuis Antwerpen /ID# 159566 | Edegem | Antwerpen | 2650 | Belgium |
| Cliniques Universitaires Saint Luc /ID# 159567 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| Centro de Pesquisas Oncologicas /ID# 163567 | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Hospital de Cancer de Barretos /ID# 163568 | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital do Cancer Mae de Deus /ID# 163416 | Porto Alegre | 90470-150 | Brazil |
| Casa de Saúde Santa Marcelina /ID# 163413 | São Paulo | 08270-070 | Brazil |
| University of Alberta Hospital /ID# 159646 | Edmonton | Alberta | T6G 2G3 | Canada |
| CISSS de la Monteregie /ID# 159782 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hospital Maisonneuve-Rosemont /ID# 159780 | Montreal | Quebec | H1T 2M4 | Canada |
| Hopital Sacre Coeur Montreal /ID# 160982 | Montreal | Quebec | H4J 1C5 | Canada |
| Fujian Medical Univ Union Hosp /ID# 167321 | Fuzhou | Fujian | 350001 | China |
| Nanfang Hospital of Southern Medical University /ID# 170147 | Guangzhou | Guangdong | 510515 | China |
| Jiangsu Province People's Hospital /ID# 167511 | Nanjing | Jiangsu | 210029 | China |
| The First Hosp of Jilin Univ /ID# 167512 | Changchun | Jilin | 130021 | China |
| Ruijin Hospital, Shanghai Jiaotong /ID# 167325 | Shanghai | Shanghai Municipality | 200025 | China |
| West China Hospital /ID# 167514 | Chengdu | Sichuan | 610041 | China |
| Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509 | Tianjin | Tianjin Municipality | 300020 | China |
| The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324 | Hangzhou | Zhejiang | 310003 | China |
| Qilu Hospital of Shandong Univ /ID# 167507 | Jinan | 250014 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515 | Wuhan | 430022 | China |
| Henan Cancer Hospital /ID# 167327 | Zhengzhou, Henan | 450008 | China |
| Fakultni Nemocnice Brno /ID# 159247 | Brno | 625 00 | Czechia |
| Univ Hosp Ostrava-Poruba /ID# 159246 | Ostrava | 708 52 | Czechia |
| Fakult Nem Kralovske Vinohrady /ID# 159248 | Prague | 100 34 | Czechia |
| Centre Hospitalier Lyon Sud /ID# 159705 | Pierre-Bénite | Rhone | 69495 | France |
| Centre Hospitalier Le Mans /ID# 159702 | Le Mans | Sarthe | 72037 | France |
| Centre Hospitalier de la Cote /ID# 159697 | Bayonne | 64100 | France |
| CHU Bordeaux /ID# 159704 | Pessac | 33600 | France |
| CHU De Nancy /ID# 159700 | Vandœuvre-lès-Nancy | 54511 | France |
| Schwarzwald-Baar-Klinikum /ID# 159571 | Villingen-Schwenningen | Baden-Wurttemberg | 78052 | Germany |
| Vivantes Klinikum Am Urban /ID# 159569 | Berlin | 10967 | Germany |
| Universitaetsklinikum Hamburg /ID# 161760 | Hamburg | 20246 | Germany |
| General Hospital of Athens Laiko /ID# 157870 | Athens | Attica | 115 27 | Greece |
| Gen Univ Hosp Alexandroupolis /ID# 157868 | Alexandroupoli | 68100 | Greece |
| General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869 | Athens | 10676 | Greece |
| University Gen Hosp of Patra /ID# 157871 | Pátrai | 26504 | Greece |
| General Hospital of Thessaloniki George Papanikolaou /ID# 157867 | Thessaloniki | 57010 | Greece |
| Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127 | Budapest IX | Budapest | 1097 | Hungary |
| Pecsi Tudomanyegyetem /ID# 163161 | Pécs | Pecs | 7624 | Hungary |
| Semmelweis Egyetem I. Belklini /ID# 158180 | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Koz /ID# 158178 | Debrecen | 4032 | Hungary |
| Petz Aladar Megyei Oktato Korh /ID# 161739 | Győr | 9023 | Hungary |
| Kaposi Mor Oktato Korhaz /ID# 158175 | Kaposvár | 7400 | Hungary |
| Bacs-Kiskun Megyei Korhaz /ID# 160973 | Kecskemét | 6000 | Hungary |
| St. James's Hospital /ID# 162730 | Dublin | Dublin | D08 E9P6 | Ireland |
| Beaumont Hospital /ID# 162733 | Dublin | D09 XR63 | Ireland |
| University Hospital Galway /ID# 162734 | Galway | H91 YR71 | Ireland |
| University Hospital Limerick /ID# 162735 | Limerick | V94F858 | Ireland |
| University of Fukui Hospital /ID# 159770 | Yoshida-gun | Fukui | 910-1193 | Japan |
| Kyushu University Hospital /ID# 159688 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Gunmaken Saiseikai Maebashi Hospital /ID# 160597 | Maebashi | Gunma | 371-0821 | Japan |
| National Hospital Organization Mito Medical Center /ID# 162988 | Higashi Ibaraki-gun | Ibaraki | 3113193 | Japan |
| Kyoto Prefect Univ Med /ID# 160101 | Kyoto | Kyoto | 602-8566 | Japan |
| Tohoku University Hospital /ID# 161151 | Sendai | Miyagi | 980-8574 | Japan |
| Nagasaki University Hospital /ID# 160233 | Nagasaki | Nagasaki | 852-8501 | Japan |
| Osaka City University Hospital /ID# 159722 | Osaka | Osaka | 545-0051 | Japan |
| Kinki University -Osakasayama Campus /ID# 160777 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Tokyo Metropolitan Komagome Hospital /ID# 160759 | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| Tokyo Jikei Daisan Hospital /ID# 159769 | Komae-shi | Tokyo | 201-8601 | Japan |
| NTT Medical Center Tokyo /ID# 160678 | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| Yamagata University Hospital /ID# 161223 | Yamagata | Yamagata | 990-9585 | Japan |
| Akita University Hospital /ID# 160602 | Akita | 100041 | Japan |
| Saitama Med Univ Int Med Ctr /ID# 161308 | Hidaka | 350-1241 | Japan |
| NHO Nagoya Medical Center /ID# 159768 | Nagoya | 460-0001 | Japan |
| Dokkyo Medical University Hosp /ID# 159650 | Shimotsuga | 321-0293 | Japan |
| Juntendo University Hospital /ID# 159781 | Tokyo | 113-8431 | Japan |
| Instituto Nacional de Cancerol /ID# 159269 | Mexico City | Mexico City | 14080 | Mexico |
| Centro de Invest Clin Chapulte /ID# 162625 | Morelia | Michoacán | 58260 | Mexico |
| Hosp. Univ. Dr. Jose E. Gonz /ID# 159268 | Monterrey | Nuevo León | 64320 | Mexico |
| North Shore Hospital /ID# 160132 | Auckland | 0622 | New Zealand |
| Middlemore Clinical Trials /ID# 160131 | Auckland | 2025 | New Zealand |
| Haukeland University Hospital /ID# 165630 | Bergen | Hordaland | 5021 | Norway |
| Sykehuset Ostfold Kalnes /ID# 165632 | Grålum | 1714 | Norway |
| VA Caribbean Healthcare System /ID# 158999 | San Juan | 00921-3201 | Puerto Rico |
| Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991 | Kemerovo | Kemerovo Oblast | 650066 | Russia |
| Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186 | Nizhny Novgorod | Nizhny Novgorod Oblast | 603126 | Russia |
| State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126 | Ryazan | Ryazan Oblast | 390039 | Russia |
| City Clinical Hospital Botkina /ID# 164086 | Moscow | 125284 | Russia |
| Almazov North-West Federal Med /ID# 162170 | Saint Petersburg | 197341 | Russia |
| Saint Petersburg State Institu /ID# 162171 | Saint Petersburg | 198205 | Russia |
| Samara State Medical Universit /ID# 164173 | Samara | 443099 | Russia |
| saratov state medical /ID# 163130 | Saratov | 41002 | Russia |
| Yaroslavl Regional Clinic Hosp /ID# 162172 | Yaroslavl | 150062 | Russia |
| Netcare Pretoria East Hospital /ID# 157373 | Pretoria | Gauteng | 0001 | South Africa |
| Tshwane District Hospital /ID# 157361 | Pretoria | Gauteng | 0001 | South Africa |
| Pusan National University Hosp /ID# 158725 | Busan | Busan Gwang Yeogsi | 602-739 | South Korea |
| Chungnam National University Hospital /ID# 158726 | Junggu | Daejeon Gwang Yeogsi | 35015 | South Korea |
| Cath Univ Seoul St Mary's Hosp /ID# 158724 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Seoul National University Hospital /ID# 162253 | Seoul | 03080 | South Korea |
| Hospital Universitario y Politecnico La Fe /ID# 161181 | Valencia | Valenciana | 46026 | Spain |
| Hospital Infanta Leonor /ID# 161180 | Madrid | 28031 | Spain |
| National Taiwan Univ Hosp /ID# 162781 | Taipei City | Taipei | 10002 | Taiwan |
| Tri-Service General Hospital /ID# 161683 | Taipei City | Taipei | 11490 | Taiwan |
| Kaohsiung Medical University /ID# 161693 | Kaohsiung City | 80708 | Taiwan |
| Heartlands Hospital /ID# 163534 | Birmingham | B9 5SS | United Kingdom |
| University Hospital of Wales /ID# 162726 | Cardiff | CF14 4EN | United Kingdom |
| Northwick Park Hospital /ID# 162727 | Harrow | HA1 3UJ | United Kingdom |
| Derived |
| Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Champion R, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Yamauchi T, Wang J, Strickland SA, Savona MR, Lin TL, Enjeti A, Tiong IS, Lee S, Roboz GJ, Popovic R, Jiang Q, Liu Z, Sun Y, Mendes W, Chyla B, DiNardo CD. Risk stratification of low-dose cytarabine and venetoclax in patients with AML ineligible for intensive chemotherapy. Blood Adv. 2026 Feb 24;10(4):987-998. doi: 10.1182/bloodadvances.2025017083. |
| 35829925 | Derived | Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13. |
| 34599139 | Derived | Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Stevens DA, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Anagnostopoulos A, McDonald A, Murthy V, Yamauchi T, Wang J, Chyla B, Sun Y, Jiang Q, Mendes W, Hayslip J, DiNardo CD. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). Blood Cancer J. 2021 Oct 1;11(10):163. doi: 10.1038/s41408-021-00555-8. |
| FG001 |
| Venetoclax + Low Dose Cytarabine (LDAC) |
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. Participants continued treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation were met. |
| Received Treatment |
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| COMPLETED | As of 15 August 2019 |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Low Dose Cytarabine (LDAC) | Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
| BG001 | Venetoclax + Low Dose Cytarabine (LDAC) | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region | Rest of World includes Australia, Brazil, Canada, New Zealand, Puerto Rico, Russia, South Africa, South Korea, and Taiwan. | Count of Participants | Participants |
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| AML Status | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | The full analysis set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) | The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML: CR: No morphologic evidence of AML and absolute neutrophil count (ANC) ≥ 10³/μL (1,000/μL), platelets ≥ 10⁵/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, the CRi criteria are met. Participants who had no IWG disease assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) | The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) at any time point during the study assessed by the investigator. CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is a derived response based on bone marrow blast and hematology lab values, achieved when the following criteria are met:
Participants with no disease assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2 | The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML: CR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met. Participants who had no IWG disease assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1, 28 days |
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| Secondary | Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2 | The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) before initiation of Cycle 2 assessed by the investigator. CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is a derived response based on bone marrow blast and hematology lab values, achieved when when the following criteria are met:
Participants with no disease assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1, 28 days |
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| Secondary | Percentage of Participants With Complete Remission | The complete remission rate is defined as the percentage of participants with complete remission (CR) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML. CR is defined as no morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Participants who had no IWG disease assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Secondary | Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a | PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points. | Full analysis set with available data at baseline and each time point | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 1 of Cycles 3, 5, 7, and 9 |
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| Secondary | Change From Baseline in Global Health Status / Quality of Life | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting). The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life. | Full analysis set with available data at Baseline and each time point | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Day 1 of Cycles 3, 5, 7, and 9 |
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| Secondary | Event-free Survival (EFS) | Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria. PD:
Participants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy. | Full analysis set | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. |
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| Secondary | Percentage of Participants With Post Baseline Red Blood Cell (RBC) Transfusion Independence | The post baseline red blood cell (RBC) transfusion independence rate was calculated as the percentage of participants who achieved RBC transfusion independence post baseline. RBC transfusion independence is defined as a period of at least 56 consecutive days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
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| Secondary | Percentage of Participants With Post Baseline Platelet Transfusion Independence | The post baseline platelet transfusion independence rate was calculated as the percentage of participants who achieved platelet transfusion independence post Baseline. Platelet transfusion independence is defined as a period of at least 56 consecutive days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut--off date, whichever occurred earlier. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
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| Secondary | Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline | The rate of conversion was calculated as the percentage of participants who were post-baseline RBC transfusion independent among participants who had an RBC transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). RBC transfusion independence is defined as a period of at least 56 days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier. | Full analysis set participants who were RBC transfusion-dependent at Baseline | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
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| Secondary | Percentage of Participants With Platelet Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline | The rate of conversion was calculated as the percentage of participants who were post-baseline platelet transfusion independent among participants who had a platelet transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). Platelet transfusion independence is defined as a period of at least 56 days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier. | Full analysis participants who were platelet transfusion dependent at Baseline | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response | The percentage of participants with complete remission or complete remission with incomplete blood count recovery AND minimal residual disease (MRD) as assessed by the investigator. Response was based on the modified IWG response criteria for AML: CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria are met. MRD response (at lowest-point MRD value) was defined as having less than 10-³ residual blasts per leukocyte measured in the bone marrow, per European LeukemiaNet (ELN) recommendations. Participants who had no disease or MRD assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) and Minimal Residual Disease (MRD) Response | The percentage of participants with complete remission or complete remission with partial hematologic recovery (CRh) AND MRD response as assessed by the investigator. CR is defined according to the modified IWG response criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is achieved when the following criteria are met:
MRD response (at lowest-point MRD value) was defined as less than 10-³ residual blasts per leukocyte measured in the bone marrow, per ELN recommendations. Participants who had no disease or MRD assessments were considered to be non-responders. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Secondary | Overall Survival (OS) by Mutation Subgroups | Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. Overall survival was analyzed in participants with the following molecular markers:
| The full analysis set; participants in each mutation subgroup | Posted | Median | 95% Confidence Interval | months | From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Mutation Subgroup | Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML: CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria is met. Participants who had no IWG disease assessments were considered to be non-responders. Response was analyzed in participants with the following mutations:
| Full analysis set participants in each mutation subgroup | Posted | Number | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Secondary | Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup | The percentage of participants who achieved a complete remission or complete remission with partial hematologic recovery assessed by the investigator for participants with the following mutations:
CR is defined according to the modified IWG criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is achieved when the following criteria are met:
| Full analysis set participants in each mutation subgroup | Posted | Number | percentage of participants | Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. |
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| Post-Hoc | Overall Survival After an Additional 6-Months Follow-up | Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology. | Full analysis set | Posted | Median | 95% Confidence Interval | months | From randomization until the 6-month follow-up analysis cut-off date of August 15, 2019; the median follow-up time was 17.7 months (range: 0.2-20.8) in the placebo arm and 17.5 months (range: 0.1-23.5) in the venetoclax arm. |
|
|
All-cause mortality includes all deaths up to the data cut-off date of 15 August 2019; median time on study was 17.7 months (range: 0.2-20.8) in the placebo arm and 17.5 months (range: 0.1-23.5) in the venetoclax arm. Adverse events are reported from the first dose of study drug up to 30 days after the last dose, to the data cut-off date of 15 August 2019; median duration of treatment was 1.7 months (range: 0.1-20.2) in the placebo arm and 4.1 months (range: 0.0-23.5) in the venetoclax arm.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Low Dose Cytarabine (LDAC) | Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. | 54 | 68 | 42 | 68 | 65 | 68 |
| EG001 | Venetoclax + Low Dose Cytarabine (LDAC) | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. | 99 | 142 | 95 | 142 | 135 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPERLEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| EYELID HAEMATOMA | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| RETINAL HAEMORRHAGE | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GASTRITIS EROSIVE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GASTRITIS HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABSCESS NECK | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ASPERGILLUS INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CANDIDA SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ENTEROCOCCAL INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ESCHERICHIA BACTERAEMIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| EXTERNAL EAR CELLULITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| KLEBSIELLA INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| KLEBSIELLA SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| LIVER ABSCESS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| LUNG INFECTION PSEUDOMONAL | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| METAPNEUMOVIRUS INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| MUCORMYCOSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| OROPHARYNGEAL CANDIDIASIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PAROTITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PSEUDOMONAL BACTERAEMIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PSOAS ABSCESS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PULMONARY MYCOSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| SERRATIA BACTERAEMIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| TRAUMATIC HAEMOTHORAX | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL CONDITION ABNORMAL | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| TUMOUR ASSOCIATED FEVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| CEREBRAL HAEMATOMA | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ORTHOSTATIC INTOLERANCE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LARYNGEAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PULMONARY ALVEOLAR HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SKIN DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2018 | Feb 6, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| D003561 | Cytarabine |
| 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 |
Not provided
Not provided
| 65 to < 75 years |
|
| ≥ 75 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| European Union |
|
| China |
|
| Japan |
|
| Rest of World |
|
| Secondary |
|
| Log Rank |
Unstratified analysis |
| 0.103 |
| Hazard Ratio (HR) |
| 0.743 |
| 2-Sided |
| 95 |
| 0.521 |
| 1.061 |
The hazard ratio was estimated using the Cox proportional hazards model. |
| Superiority |
| OG001 | Venetoclax + Low Dose Cytarabine (LDAC) | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
|
| OG001 |
| Venetoclax + Low Dose Cytarabine (LDAC) |
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
|
|
|
|
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| OG001 | Venetoclax + Low Dose Cytarabine (LDAC) | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
|
| OG001 | Venetoclax + Low Dose Cytarabine (LDAC) | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
| OG001 | Venetoclax + Low Dose Cytarabine (LDAC) | Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle. |
|
|
|
|