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A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax 400 mg + azacitidine 75 mg | Experimental | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. |
|
| Venetoclax 400 mg + decitabine 20 mg | Experimental | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents. |
| 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 bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) > 10^3/μL (1,000/μL), platelets > 10^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts CRi: Bone marrow with < 5% blasts, and absolute neutrophils of ≤ 10^3/μL or platelets ≤ 10^5/μL | Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission (CR) | 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 bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) > 10^3/μL (1,000/μL), platelets > 10^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts |
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Inclusion Criteria:
Exclusion Criteria:
Has a history of the following conditions:
Has a history of other malignancies within 2 years prior to study entry, with the exception of:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC-HOPE /ID# 211509 | Tempe | Arizona | 85284-1812 | United States | ||
| Colorado Blood Cancer Institute /ID# 212800 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38711253 | Derived | Manda S, Anz BM 3rd, Benton C, Broun ER, Yimer HA, Renshaw JS, Geils G Jr, Berdeja J, Cruz J, Melear JM, Fanning S, Fletcher L, Li Y, Duan Y, Werner ME, Potluri J, Pai MV, Donnellan WB. A phase 3b study of venetoclax and azacitidine or decitabine in an outpatient setting in patients with acute myeloid leukemia. Hematol Oncol. 2024 May;42(3):e3274. doi: 10.1002/hon.3274. |
| 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, analyses plans, 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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
All participants who received at least one dose of venetoclax and azacitidine or decitabine; this study disposition represents the primary reason for venetoclax discontinuation
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| ID | Title | Description |
|---|---|---|
| FG000 | Venetoclax 400 mg + Azacitidine 75 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. |
| 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 | Oct 29, 2020 | Feb 22, 2023 |
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| Azacitidine | Drug | The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice. |
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| Decitabine | Drug | The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice. |
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| Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. |
| Percentage of Participants With Complete Remission With Incomplete Blood Count Recovery (CRi) | The complete remission with incomplete blood count recovery rate is defined as the percentage of participants with complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CRi: Bone marrow with < 5% blasts, and absolute neutrophils of ≤ 10^3/μL or platelets ≤ 10^5/μL. | Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. |
| Percentage of Participants With Post-baseline Transfusion Independence | The transfusion independence rate is defined as the percentage of participants with post-baseline transfusion independence, which is defined as a period of at least 56 days with no transfusion after the first dose of study drug and within 30 days of the last dose of study drug, death, or initiation of post-treatment therapy, whichever is earliest. | From the first dose of study drug to the last dose of study drug +30 days, or death, or initiation of post-treatment therapy, whichever occurred earliest. Median time on follow-up was 183.5 days and 195.0 days, respectively. |
| Denver |
| Colorado |
| 80218 |
| United States |
| Rocky Mountain Cancer Centers /ID# 211508 | Lone Tree | Colorado | 80124 | United States |
| Fort Wayne Medical Oncology /ID# 223523 | Fort Wayne | Indiana | 46804 | United States |
| Minnesota Oncology Hematology, PA /ID# 212837 | Minneapolis | Minnesota | 55404 | United States |
| Oncology Hematology Care, Inc. /ID# 212779 | Cincinnati | Ohio | 45236-2725 | United States |
| Willamette Valley Cancer Institute and Research Center /ID# 211504 | Eugene | Oregon | 97401-6043 | United States |
| Charleston Oncology, P.A. /ID# 211471 | Charleston | South Carolina | 29414-7710 | United States |
| Prisma Health Cancer Inst - Eastside /ID# 211466 | Greenville | South Carolina | 29615 | United States |
| Tennessee Oncology - Chattanooga / McCallie /ID# 212717 | Chattanooga | Tennessee | 37404-3230 | United States |
| Tennessee Oncology-Nashville Centennial /ID# 210944 | Nashville | Tennessee | 37203-1632 | United States |
| Texas Oncology - Austin Midtown /ID# 212780 | Austin | Texas | 78705 | United States |
| Texas Oncology - Medical City Dallas /ID# 211503 | Dallas | Texas | 75230 | United States |
| Texas Transplant Institute /ID# 213311 | San Antonio | Texas | 78229 | United States |
| Texas Oncology - San Antonio Medical Center /ID# 211510 | San Antonio | Texas | 78240-5251 | United States |
| Texas Oncology - Northeast Texas /ID# 213908 | Tyler | Texas | 75702 | United States |
| FG001 | Venetoclax 400 mg + Decitabine 20 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. |
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| NOT COMPLETED |
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All participants who received at least one dose of venetoclax and azacitidine or decitabine
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| ID | Title | Description |
|---|---|---|
| BG000 | Venetoclax 400 mg + Azacitidine 75 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. |
| BG001 | Venetoclax 400 mg + Decitabine 20 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| 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 | 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 bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) > 10^3/μL (1,000/μL), platelets > 10^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts CRi: Bone marrow with < 5% blasts, and absolute neutrophils of ≤ 10^3/μL or platelets ≤ 10^5/μL | All participants who received at least one dose of venetoclax and azacitidine or decitabine | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. |
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| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Remission (CR) | 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 bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) > 10^3/μL (1,000/μL), platelets > 10^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts | All participants who received at least one dose of venetoclax and azacitidine or decitabine | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Remission With Incomplete Blood Count Recovery (CRi) | The complete remission with incomplete blood count recovery rate is defined as the percentage of participants with complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CRi: Bone marrow with < 5% blasts, and absolute neutrophils of ≤ 10^3/μL or platelets ≤ 10^5/μL. | All participants who received at least one dose of venetoclax and azacitidine or decitabine | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively. |
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| Secondary | Percentage of Participants With Post-baseline Transfusion Independence | The transfusion independence rate is defined as the percentage of participants with post-baseline transfusion independence, which is defined as a period of at least 56 days with no transfusion after the first dose of study drug and within 30 days of the last dose of study drug, death, or initiation of post-treatment therapy, whichever is earliest. | All participants who received at least one dose of venetoclax and azacitidine or decitabine | Posted | Number | 95% Confidence Interval | percentage of participants | From the first dose of study drug to the last dose of study drug +30 days, or death, or initiation of post-treatment therapy, whichever occurred earliest. Median time on follow-up was 183.5 days and 195.0 days, respectively. |
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All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venetoclax 400 mg + Azacitidine 75 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. | 5 | 30 | 19 | 30 | 29 | 30 |
| EG001 | Venetoclax 400 mg + Decitabine 20 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. | 8 | 30 | 22 | 30 | 30 | 30 |
| EG002 | Venetoclax 400 mg + Azacitidine 75 mg or Decitabine 20 mg | Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. | 13 | 60 | 41 | 60 | 59 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
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| PROCTALGIA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 25.0 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 25.0 | Systematic Assessment |
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| DISEASE PROGRESSION | General disorders | MedDRA 25.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| ESCHERICHIA BACTERAEMIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PERINEAL ABSCESS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 25.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 25.0 | Systematic Assessment |
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| INJECTION SITE REACTION | General disorders | MedDRA 25.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 25.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 25.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 25.0 | Systematic Assessment |
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| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| PLATELET COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 25.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| PRESYNCOPE | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2022 | Feb 22, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| D001374 | Azacitidine |
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
|
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. |
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Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle. |
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