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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003434-36 | EudraCT Number | ||
| MOH_2022-08-15_011983 | Registry Identifier | Israel Clinical Research Site |
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Study was terminated due to futility
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The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magrolimab + Venetoclax + Azacitidine | Experimental | Participants will receive
Each cycle is 28 days. |
|
| Magrolimab Matching Placebo + Venetoclax + Azacitidine | Placebo Comparator | Participants will receive
Each cycle is 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magrolimab | Drug | Administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was measured from the date of randomization to the date of death from any cause. Participants were censored at last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Up to 1.6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh) | The CR + CRh rate was defined as the percentage of participants who achieved a CR (including CR without minimal residual disease (CRMRD-) and CR with positive or unknown MRD (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). CRMRD- and CRMRD+/unk: neutrophils >1.0 ×10^9/L, platelets >100 ×10^9/L, <5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry <0.1% sensitivity for CRMRD-) within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. |
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Key Inclusion Criteria:
Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. Individuals must be considered ineligible for intensive chemotherapy, defined by the following:
≥ 75 years of age; Or
≥ 18 to 74 years of age with at least 1 of the following comorbidities:
ECOG performance status:
Individuals with white blood cell (WBC) count ≤ 20 x 10^3/μL prior to randomization. If the individual's WBC is > 20 x10^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20 x 10^3/μL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1.
Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment
Pretreatment blood cross-match completed
Key Exclusion Criteria:
Prior treatment with any of the following:
cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents
Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea
Clinical suspicion of or documented active central nervous system (CNS) involvement with AML
Individuals who have acute promyelocytic leukemia
Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40233321 | Derived | Daver N, Vyas P, Huls G, Dohner H, Maury S, Novak J, Papayannidis C, Martinez Chamorro C, Montesinos P, Niroula R, Fenaux P, Esteve J, Wu SJ, De Voeght A, Mayer J, Valk PJM, Johnson L, Dong M, Liu K, Kuwahara S, Caldwell K, Guru Murthy GS. The ENHANCE-3 study: venetoclax and azacitidine plus magrolimab or placebo for untreated AML unfit for intensive therapy. Blood. 2025 Jul 31;146(5):601-611. doi: 10.1182/blood.2024027506. | |
| 37703506 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Participants were enrolled at study sites in Asia, Europe, North America and Australia.
502 participants were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Magrolimab + Venetoclax + Azacitidine | Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
| 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 | Dec 15, 2023 | Feb 11, 2025 |
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| Venetoclax | Drug | Tablets administered orally |
|
|
| Azacitidine | Drug | Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV) |
|
| Placebo | Drug | Administered intravenously (IV) |
|
| Up to 1.6 years |
| Rate of Complete Remission (CR) | CR was defined as the percentage of the participants who achieved CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT) within the response assessment window of 1.6 years. Definitions for CRMRD- and CRMRD+/unk were mentioned in outcome measure #2. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. | Up to 1.6 years |
| Event-Free Survival (EFS) | EFS was defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause within the response window. KM estimates were used in outcome measure analysis. CR is defined in outcome measure 2. | Up to 1.6 years |
| Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) | The duration of CR + CRh was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cut off date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR and CRh are defined in Outcome Measure #2. Each cycle was of 28 days. | Up to 1.6 years |
| Duration of Complete Remission (DCR) in Participants Who Achieved Complete Remission (CR) | The DCR was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cutoff date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. KM estimates were used in outcome measure analysis. CRMRD- and CRMRD+/unk are defined in outcome measure #2. Each cycle was of 28 days. | Up to 1.6 years |
| Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-) | The CR/CRhMRD- rate was the percentage of participants who achieved a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 1.6 years. Each cycle was of 28 days. KM estimates were used for outcome measure analysis. CRhMRD- : neutrophils > 0.5 x 10^9/L; platelets > 50 x 10^9/L; bone marrow blasts < 5%; MRD negative (determined using multiparameter flow cytometry with a sensitivity of < 0.1%). Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Percentages were rounded off. | Up to 1.6 years |
| Rate of CR Without Minimal Residual Disease (CRMRD-) | The CRMRD- rate was the percentage of participants who achieved a CRMRD- within 6 cycles of treatment SCT within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. CRMRD is defined in outcome measure #2. Each cycle was of 28 days. Percentages were rounded off | Up to 1.6 years |
| Red Blood Cell (RBC) Transfusion Independence Conversion Rate | The RBC transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were RBC transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 1.6 years |
| Platelet Transfusion Independence Conversion Rate | The platelet transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no platelet transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were platelet transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 1.6 years |
| Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale | The TTD on the EORTC QLQ-C30 GHS/QoL scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever was earlier. Questionnaire includes 30 questions resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 GHS/QoL scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). After linear transformation, all scales and single item measures range in score from 0-100. Higher score on GHS/QoL scale meant better GHS/QoL. KM estimates were used in outcome measure analysis. | Up to 1.6 years |
| Time to First Deterioration (TTD) on the EORTC QLQ-C30 Physical Functioning Scale | The TTD on the EORTC QLQ-C30 physical functioning scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Physical functioning scale is one of the five functional scales of the EORTC QLQ C30 questionnaire. After linear transformation, scale range in score from 0-100. A higher score on functional scales means better functioning and better quality of life. KM estimates were used in outcome measure analysis. | Up to 1.6 years |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dose date or the day before initiation of new anti-AML therapy including stem cell transplantation, whichever is earlier. Percentages were rounded-off. | First dose date up to 1.4 years plus 70 days |
| Percentage of Participants Experiencing Grade 3 or Higher Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 70 days or the day before the initiation of new anti-AML therapy including SCT, whichever came first, and were summarized by treatment group. Severity grades were defined by the CTCAE Version 5.0. 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-Threatening; 5 = Death. Percentages were rounded-off. | First dose date up to 1.4 years, plus 70 days |
| Serum Concentration of Magrolimab Over Time | Predose on Day 1, Day 8, Day 15, Day 29; Predose on Day 57 and 1 hour post-dose; Predose on Day 113, Day 169, Day 253, and Day 337. |
| Percentage of Participants With Anti-Magrolimab Antibodies | Percentages were rounded off. | Up to 1.6 years |
| Maximum Levels of Serum Anti-Magrolimab Antibodies | Up to 1.6 years |
| Duarte |
| California |
| 91010 |
| United States |
| Community Cancer Institute | Fresno | California | 93730 | United States |
| UC Irvine Health- Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| Indiana Blood and Marrow Transplantation - Clinic | Indianapolis | Indiana | 46237 | United States |
| The University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| University of Massachusetts Worcester | Worcester | Massachusetts | 01655 | United States |
| MidAmerica Division, Inc., c/o Research Medical Center | Kansas City | Missouri | 64132 | United States |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| New York-Presbyterian/Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital | New York | New York | 10029 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Novant Health Cancer Institute Hematology- Charlotte | Charlotte | North Carolina | 28204 | United States |
| Novant Health Cancer Institute Hematology - Forsyth | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Houston Methodist Hospital Cancer Center | Houston | Texas | 77030 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Intermountain Health - LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Virginia Mason Franciscan Health | Seattle | Washington | 98101 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Canberra Hospital | Woden | Australian Capital Territory | 2606 | Australia |
| Border Medical Oncology Research Unit | Albury | New South Wales | 2640 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services | Sydney | New South Wales | 2217 | Australia |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Monash University, Eastern Health-Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Northern Health | Epping | Victoria | 3076 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Ordensklinikum Linz GmbH Elisabethinen | Linz | Austria |
| Wiener Gesundheitsverbund, Klinik Hietzing | Vienna | 1130 | Austria |
| Hanusch Krankenhaus | Vienna | 1140 | Austria |
| Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg | Antwerp | 2060 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| University Hospital Gent | Ghent | 9000 | Belgium |
| Hopital de Jolimont | Haine-Saint-Paul | 7100 | Belgium |
| University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| Queen Elizabeth II (QEII) Health Sciences Centre | Halifax | B3H 1V7 | Canada |
| Centre Integre Universitaire de Sante et de Services Sociaux(CIUSSS) de l'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont | Montreal | H1T 2M4 | Canada |
| Princess Margaret Cancer Centre - University Health Network | Toronto | M5G 2M9 | Canada |
| CancerCare Manitoba | Winnipeg | R3E 0V9 | Canada |
| Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika FN Brno a LF MU | Jihormoravsky KRAJ | 625 00 | Czechia |
| Fakultni nemocine Olomouc, Hemato-onkologicka klinika | Olomouc | 77520 | Czechia |
| Fakultni nemocnice Ostrava, Klinika hematoonkologie | Ostrava | 70852 | Czechia |
| Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance | Prague | 128 08 | Czechia |
| CHU Amiens Picardie | Amiens | 80054 | France |
| CHU d'Angers | Angers | 49033 | France |
| Hopital Avicenne | Bobigny | 93000 | France |
| Hopitaux Universitaires Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | 38700 | France |
| Centre Hospitalier de Versailles | Le Chesnay | 78157 | France |
| Hôpital Claude Huriez (CHRU de Lillle) | Lille | 59037 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Centre Hospitalier Universitaire Nantes - Hotel Dieu | Nantes | 44093 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon-Sud (CHLS) | Pierre-Bénite | 69495 | France |
| Institut de Cancérologie Strasbourg Europe (ICANS) | Strasbourg | 67033 | France |
| Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole | Toulouse | 31059 | France |
| CHU de Nancy - Hopitaux de Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Charite - Universitatsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie, Onkologie und Tumorimmunologie | Berlin | 13353 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Städtisches Klinikum Braunschweig GmbH Medizinische Klinik III/Hämatologie und Onkologie | Braunschweig | 38114 | Germany |
| Universitatsklinikum Dusseldorf, Klink fur Hamatologie, Onkologie und Klinische Immunologie | Düsseldorf | 40225 | Germany |
| Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin | Düsseldorf | 40479 | Germany |
| Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I | Flensburg | 24939 | Germany |
| Universitatsklinikum Frankfurt Goethe Universitat Med. Klink II | Frankfurt | 60590 | Germany |
| Asklepios Klink St.Georg | Hamburg | 20099 | Germany |
| Medizinische Hochschule Hannover, Hamatologie, Hamostaseologie, Onkologie und Stammzelltrandsplantation | Hanover | 30625 | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | 39120 | Germany |
| Johannes Wesling Klinikum Minden Universitätsklinik fur Hämatologie, Onkologie, Hämostaseologie und Pastativrndezin, Universitatsklinik der Ruhr-Unive | Minden | 32429 | Germany |
| Klinikum rechts der Isar Technischen Universitat Munchen | München | 81675 | Germany |
| Klinikum Oldenburg, Rahel-Straus-Straße 10 | Oldenburg | 26133 | Germany |
| Universitatsklinikum Regensburg, Klink fur Innere Medizin III | Regensburg | 93053 | Germany |
| Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Klinik fur Innere Medizin III | Ulm | 89070 | Germany |
| Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital | Hong Kong | Hong Kong |
| Princess Margaret Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika | Budapest | 1083 | Hungary |
| Petz Aladár Egyetemi Oktató Kórház II. Belgyógyaszat - Haematológia | Győr | 9024 | Hungary |
| Debreceni Egyetem Klinikai Központ Belgyogyaszati Klinika B epulet Hematologia | Hajdu-bihar | 4032 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Kozpont | Szeged | 6725 | Hungary |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah University Hospital Ein Kerem | Jerusalem | 91120 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Azienda Ospedaliero Universitaria delle Marche - SOD Clinica di Ematologia | Ancona | I-60126 | Italy |
| ASST Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi | Bologna | 40138 | Italy |
| IRCCS Istituto Clinico Humanitas | Milan | 20089 | Italy |
| ASST Monza-Ospedale San Gerardo | Monza | 20052 | Italy |
| Azienda Ospedaliera di Perugia - Santa Maria della Misericordia | Perugia | Italy |
| Azienda Sanitaria Territoriale Pesaro e Urbino - "Stabilimento Ospedaliero San Salvatore - Muraglia" - U.O. Ematologia e Centro Trapianti | Pesaro | 61122 | Italy |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223GZ | Netherlands |
| Meander Medisch Centrum | Amersfoort | 3813 TZ | Netherlands |
| Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Amphia Hospital, department Oncologie, Route 43 | Breda | 4818 CK | Netherlands |
| Medisch Spectrum Twente - Enschede Koningsplein | Enschede | 7512 KZ | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9700 RB | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Masstricht Universitair Medisch Centrum | Maastricht | 62002 | Netherlands |
| St. Antonius Ziekenhuis, Nieuwegein | Nieuwegein | 3435 CM | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3000 CA | Netherlands |
| HagaZiekenhuis | The Hague | 2545AA | Netherlands |
| Oslo University Hospital, Department of Hematology | Oslo | 0424 | Norway |
| Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi, Oddzial Hematologii Ogolnej | Lodz | 93-510 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny | Lublin | 20090 | Poland |
| Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych | Opole | 45-372 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Severance Hospital | Seoul | 120-752 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| The Catholic University of Korea Seoul Saint Mary's Hospital | Seoul | 6591 | South Korea |
| Hospital Universitario Araba | Alava | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28041 | Spain |
| Hospital Universitario Quironsalud Madrid | Madrid | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Complejo Asistencial Universitario de Salamanca - Hospital Clinico | Salamanca | 37007 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Universitari I Politecnic La Fe | Valencia | 46026 | Spain |
| Inselspital Universitätsspital Bern | Bern | 3010 | Switzerland |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| National Cheng Kung University Hospital | Taipei | 11490 | Taiwan |
| Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | FY3 8NR | United Kingdom |
| University Hospitals Bristol and Weston NHS Foundation Trust | Bristol | BS2 8ED | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Clatterbridge Cancer Centre NHS Foundation Trust | Liverpool | L7 8YA | United Kingdom |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Newcastle upon Tyne Hospitals Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust, Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| South Warwickshire University NHS Foundation Trust | Warwick | CV34 5BW | United Kingdom |
| The Royal Wolverhampton NHS Trust | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Daver NG, Vyas P, Kambhampati S, Al Malki MM, Larson RA, Asch AS, Mannis G, Chai-Ho W, Tanaka TN, Bradley TJ, Jeyakumar D, Wang ES, Sweet K, Kantarjian HM, Garcia-Manero G, Komrokji R, Xing G, Ramsingh G, Renard C, Zeidner JF, Sallman DA. Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results. J Clin Oncol. 2023 Nov 1;41(31):4893-4904. doi: 10.1200/JCO.22.02604. Epub 2023 Sep 13. |
| FG001 | Magrolimab Matching Placebo + Venetoclax + Azacitidine | Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
| COMPLETED |
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| NOT COMPLETED |
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|
The Intent-to-Treat Analysis Set included all randomized participants according to the treatment arm to which the participants were randomized, unless otherwise specified.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Magrolimab + Venetoclax + Azacitidine | Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
| BG001 | Magrolimab Matching Placebo + Venetoclax + Azacitidine | Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
| 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Overall Survival (OS) | OS was measured from the date of randomization to the date of death from any cause. Participants were censored at last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Participants in the Intent-to-Treat Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 1.6 years |
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| Secondary | Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh) | The CR + CRh rate was defined as the percentage of participants who achieved a CR (including CR without minimal residual disease (CRMRD-) and CR with positive or unknown MRD (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). CRMRD- and CRMRD+/unk: neutrophils >1.0 ×10^9/L, platelets >100 ×10^9/L, <5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry <0.1% sensitivity for CRMRD-) within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. | Participants in the Intent-to-Treat analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.6 years |
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| Secondary | Rate of Complete Remission (CR) | CR was defined as the percentage of the participants who achieved CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT) within the response assessment window of 1.6 years. Definitions for CRMRD- and CRMRD+/unk were mentioned in outcome measure #2. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. | Participants in the Intent-To-Treat Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.6 years |
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| Secondary | Event-Free Survival (EFS) | EFS was defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause within the response window. KM estimates were used in outcome measure analysis. CR is defined in outcome measure 2. | Participants in the Intent-To-Treat Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 1.6 years |
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| Secondary | Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) | The duration of CR + CRh was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cut off date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR and CRh are defined in Outcome Measure #2. Each cycle was of 28 days. | Participants in the Intent-To-Treat Analysis Set who achieved CR + CRh within 6 cycles were analyzed. Each cycle was of 28 days. | Posted | Median | 95% Confidence Interval | months | Up to 1.6 years |
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| Secondary | Duration of Complete Remission (DCR) in Participants Who Achieved Complete Remission (CR) | The DCR was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cutoff date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. KM estimates were used in outcome measure analysis. CRMRD- and CRMRD+/unk are defined in outcome measure #2. Each cycle was of 28 days. | Participants in the Intent-To-Treat Analysis Set who achieved CR within 6 cycle in all participants were analyzed. Each cycle was of 28 days. | Posted | Median | 95% Confidence Interval | months | Up to 1.6 years |
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| Secondary | Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-) | The CR/CRhMRD- rate was the percentage of participants who achieved a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 1.6 years. Each cycle was of 28 days. KM estimates were used for outcome measure analysis. CRhMRD- : neutrophils > 0.5 x 10^9/L; platelets > 50 x 10^9/L; bone marrow blasts < 5%; MRD negative (determined using multiparameter flow cytometry with a sensitivity of < 0.1%). Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Percentages were rounded off. | Participants in the Intent-To-Treat Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.6 years |
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| Secondary | Rate of CR Without Minimal Residual Disease (CRMRD-) | The CRMRD- rate was the percentage of participants who achieved a CRMRD- within 6 cycles of treatment SCT within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. CRMRD is defined in outcome measure #2. Each cycle was of 28 days. Percentages were rounded off | Participants in the Intent-To-Treat Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.6 years |
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| Secondary | Red Blood Cell (RBC) Transfusion Independence Conversion Rate | The RBC transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were RBC transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants in the Intent-To-Treat Analysis Set with RBC transfusion dependence at Baseline were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.6 years |
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| Secondary | Platelet Transfusion Independence Conversion Rate | The platelet transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no platelet transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were platelet transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants in the Intent-To-Treat Analysis Set with Platelet transfusion dependence at Baseline were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1.6 years |
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| Secondary | Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale | The TTD on the EORTC QLQ-C30 GHS/QoL scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever was earlier. Questionnaire includes 30 questions resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 GHS/QoL scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). After linear transformation, all scales and single item measures range in score from 0-100. Higher score on GHS/QoL scale meant better GHS/QoL. KM estimates were used in outcome measure analysis. | Participants in the Intent-To-Treat Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 1.6 years |
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| Secondary | Time to First Deterioration (TTD) on the EORTC QLQ-C30 Physical Functioning Scale | The TTD on the EORTC QLQ-C30 physical functioning scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Physical functioning scale is one of the five functional scales of the EORTC QLQ C30 questionnaire. After linear transformation, scale range in score from 0-100. A higher score on functional scales means better functioning and better quality of life. KM estimates were used in outcome measure analysis. | Participants in the Intent-To-Treat Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 1.6 years |
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| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dose date or the day before initiation of new anti-AML therapy including stem cell transplantation, whichever is earlier. Percentages were rounded-off. | The Safety Analysis Set included all participants who received at least 1 dose of any study treatment, with treatment assignments designated according to the actual treatment received. | Posted | Number | percentage of participants | First dose date up to 1.4 years plus 70 days |
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| Secondary | Percentage of Participants Experiencing Grade 3 or Higher Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 70 days or the day before the initiation of new anti-AML therapy including SCT, whichever came first, and were summarized by treatment group. Severity grades were defined by the CTCAE Version 5.0. 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-Threatening; 5 = Death. Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to 1.4 years, plus 70 days |
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| Secondary | Serum Concentration of Magrolimab Over Time | The Pharmacokinetic (PK) Analysis Set included all randomized participants who took at least one dose of magrolimab and have at least 1 measurable (non - below the limit of quantitation (BLQ) numeric values) post-treatment serum concentration of magrolimab with data available for analysis. | Posted | Mean | Standard Deviation | µg/mL | Predose on Day 1, Day 8, Day 15, Day 29; Predose on Day 57 and 1 hour post-dose; Predose on Day 113, Day 169, Day 253, and Day 337. |
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| Secondary | Percentage of Participants With Anti-Magrolimab Antibodies | Percentages were rounded off. | The participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set included all randomized participants who received at least one dose of magrolimab and had at least one evaluable anti-magrolimab antibody test result. | Posted | Number | percentage of participants | Up to 1.6 years |
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| Secondary | Maximum Levels of Serum Anti-Magrolimab Antibodies | Data is reported for participants in the Immunogenicity Analysis Set with quantifiable measurement for ADA for magrolimab. | Posted | Mean | Standard Deviation | titer | Up to 1.6 years |
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|
All-Cause mortality: Up to 1.6 years; Adverse events: Up to 1.4 years plus 70 days
All-Cause mortality: The Intent-to-Treat Analysis Set included all participants who were randomized in the study, with treatment assignment designated according to the treatment arm the participant was randomized to.
Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
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 | Magrolimab + Venetoclax + Azacitidine | Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. | 84 | 189 | 138 | 189 | 180 | 189 |
| EG001 | Magrolimab Matching Placebo + Venetoclax + Azacitidine | Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. | 70 | 189 | 134 | 184 | 179 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Haemolysis | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Splenic infarction | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | 26.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | 26.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 26.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | 26.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | 26.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 26.1 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | 26.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | 26.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | 26.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | 26.1 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | 26.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Mouth haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Asthenia | General disorders | 26.1 | Systematic Assessment |
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| Fatigue | General disorders | 26.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | 26.1 | Systematic Assessment |
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| Hypothermia | General disorders | 26.1 | Systematic Assessment |
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| Inflammation | General disorders | 26.1 | Systematic Assessment |
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| Infusion site extravasation | General disorders | 26.1 | Systematic Assessment |
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| Malaise | General disorders | 26.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | 26.1 | Systematic Assessment |
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| Pain | General disorders | 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | 26.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | 26.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | 26.1 | Systematic Assessment |
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| Hepatic hypoperfusion | Hepatobiliary disorders | 26.1 | Systematic Assessment |
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| Abdominal sepsis | Infections and infestations | 26.1 | Systematic Assessment |
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| Abscess of salivary gland | Infections and infestations | 26.1 | Systematic Assessment |
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| Anorectal infection | Infections and infestations | 26.1 | Systematic Assessment |
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| Arthritis infective | Infections and infestations | 26.1 | Systematic Assessment |
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| Bacillus bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | 26.1 | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | 26.1 | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | 26.1 | Systematic Assessment |
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| Catheter site cellulitis | Infections and infestations | 26.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | 26.1 | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | 26.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | 26.1 | Systematic Assessment |
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| Covid-19 pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | 26.1 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | 26.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Haematological infection | Infections and infestations | 26.1 | Systematic Assessment |
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| Infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | 26.1 | Systematic Assessment |
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| Influenza | Infections and infestations | 26.1 | Systematic Assessment |
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| Infusion site cellulitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Oral infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 26.1 | Systematic Assessment |
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| Otosalpingitis | Infections and infestations | 26.1 | Systematic Assessment |
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| Paronychia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | 26.1 | Systematic Assessment |
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| Pneumonia klebsiella | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Stenotrophomonas sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Refractoriness to platelet transfusion | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 26.1 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | 26.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Troponin I increased | Investigations | 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebral microembolism | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Polyneuropathy chronic | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Aortitis | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.1 | Systematic Assessment |
| |
| Chills | General disorders | 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | 26.1 | Systematic Assessment |
| |
| Oedema | General disorders | 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2024 | Feb 11, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629291 | magrolimab |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| 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
| >= 75 Years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| Czechia |
|
| United States |
|
| United Kingdom |
|
| Switzerland |
|
| Spain |
|
| Canada |
|
| Austria |
|
| Netherlands |
|
| South Korea |
|
| Belgium |
|
| Norway |
|
| Taiwan |
|
| Poland |
|
| Italy |
|
| Israel |
|
| Australia |
|
| France |
|
| Germany |
|
| Magrolimab Matching Placebo + Venetoclax + Azacitidine |
Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
|
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|
| OG001 | Magrolimab Matching Placebo + Venetoclax + Azacitidine | Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
|
|
| OG001 |
| Magrolimab Matching Placebo + Venetoclax + Azacitidine |
Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
|
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|
|
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|
|
|
|
| OG001 |
| Magrolimab Matching Placebo + Venetoclax + Azacitidine |
Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days. |
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