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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004287-26 | EudraCT Number |
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Study discontinued due to futility based on a planned analysis
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The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magrolimab + Azacitidine | Experimental | Participants will receive the following magrolimab and azacitidine dosing regimens: Magrolimab: Magrolimab Priming Dose:
Magrolimab Maintenance Dose:
Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. |
|
| Control Arm (Placebo + Azacitidine) | Placebo Comparator | Participants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magrolimab | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission (CR) | The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off. | From randomization up to 31.01 months |
| Overall Survival (OS) | OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis. | From randomization up to 32.62 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of CR (DOCR) | DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. PD is defined as: <5% blasts: ≥50 increase in blasts to >5% blasts,5%-10% blasts: ≥50% increase in blasts to >10% blasts, 10%-20% blasts: ≥50% increase in blasts to >20% blasts,20%-30% blasts: ≥50% increase in blasts to >30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by ≥2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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 Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Arkansas for Medical Sciences IRB |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36888930 | Derived | Sallman DA, Al Malki MM, Asch AS, Wang ES, Jurcic JG, Bradley TJ, Flinn IW, Pollyea DA, Kambhampati S, Tanaka TN, Zeidner JF, Garcia-Manero G, Jeyakumar D, Komrokji R, Lancet J, Kantarjian HM, Gu L, Zhang Y, Tan A, Chao M, O'Hear C, Ramsingh G, Lal I, Vyas P, Daver NG. Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study. J Clin Oncol. 2023 May 20;41(15):2815-2826. doi: 10.1200/JCO.22.01794. Epub 2023 Mar 8. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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854 participants were screened.
Participants were enrolled at study sites in North America, Asia-Pacific Region, and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Magrolimab + Azacitidine | Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years. |
| 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 11, 2022 | Feb 9, 2024 |
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| Azacitidine | Drug | Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling |
|
| Placebo | Drug | Placebo to match magrolimab administered intravenously |
|
| From randomization up to 31.01 months |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1. PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by ≥ 50% over pretreatment but still > 5% cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks. Percentages were rounded off. | From randomization up to 31.01 months |
| Duration of Response (DOR) | DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis. | From randomization up to 31.01 months |
| Red Blood Cell (RBC) Transfusion Independence Rate | RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off. | From randomization up to 31.01 months |
| Event Free Survival (EFS) | EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first. Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis | From randomization up to 31.01 months |
| Percentage of Participants With CR in Participants With TP53 Mutation | CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off. | From randomization up to 31.01 months |
| Minimal Residual Disease (MRD)-Negative Response Rate | The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively. Percentages were rounded off. | From randomization up to 31.01 months |
| Time to Transformation to AML | Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. Transformation assessments post SCT were included in the analysis.KM estimates were used for analysis. | From randomization up to 31.01 months |
| Progression Free Survival (PFS) | PFS is defined as the time from randomization to the date of documented DP (including treatment failure by IWG criteria or relapse after PR/CR), or death from any cause, whichever occurs first. Response assessments and deaths post SCT were included in the analysis. Treatment failure is defined as, Death during treatment or disease progression characterized by worsening cytopenia, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment. Relapse after CR or PR = Return to pretreatment bone marrow blast percentage / Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets / Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR, PR and PD are defined in outcome measures 1, 4 and 5 respectively. KM estimates were used for analysis. | From randomization up to 31.01 months |
| Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate | The FACT-Anemia response rate is defined as the percentage of participants who showed clinically meaningful improvement in health-related quality of life (HRQoL) based on the score from the FACT-Anemia instrument prior to initiation of any new anticancer therapy, including SCT. The minimal clinically meaningful difference of 7.0 was used as cutoff for clinically meaningful improvement. The FACT-Anemia instrument consists of 5 subscales, including physical well-being, emotional well-being, functional well-being, social well-being, and anemia symptoms. Each subscale measures items on a 5-point Likert scale from 0 to 4, where 0 = not at all and 4 = very much. The subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest quality of life (QOL) and 100 denotes the highest QOL. Percentages were rounded off. | Up to week 136 |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) | TEAE's are defined as any AEs with an onset date on or after the study drug start date, no later than 70 days after study drug last dose date or day before initiation of new anticancer therapy including SCT. If AE onset date is on or before last dose date, it is considered as TEAE regardless of start of new anticancer therapy. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution. An event is considered "serious", if it results death, life-threatening, inpatient or prolongation hospitalization, incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, and important medical events. | First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years) |
| Serum Concentration of Magrolimab | Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of study treatment; thereafter, pretreatment assessments are to be collected within 24 hours prior to study treatment administration. | Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336 |
| Percentage of Participants With Positive Anti-magrolimab Antibodies | Percentages were rounded off. | Up to 72 hours before administration of any treatment at Day 1, Cycle 1; within 24 hours prior to any study drug administration at Day 1 of Cycles 2, 3, 5, 7, 10, and 13 and End of Treatment (± 7 Days after last study drug dose); Cycle length is 28 Days |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States |
| UC Irvine Health | Orange | California | 92868 | United States |
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States |
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute (DFCI) | Boston | Massachusetts | 02215 | United States |
| University of Michigan Medical School | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| Mid America Division, Inc. | Kansas City | Missouri | 64132 | United States |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Cornell Medicine-New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| Columbia University Medical Center - Herbert Irving Pavilion | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| DUHS Duke Cancer Center | Durham | North Carolina | 27705 | United States |
| The Ohio State University Wexner Medical Center / James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health & Science University Pharmacy Services | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Prisma Health Cancer Center | Greenville | South Carolina | 29615 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 39090 | United States |
| Texas Oncology - Baylor Charles A. Simmons Cancer Center | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98019 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Froedtert Hospital & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Gosford Hospital | Gosford | New South Wales | 2250 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Icon Cancer Foundation | South Brisbane | Queensland | 4101 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Center | Bedford Park | South Australia | 5042 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Eastern Health | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Peninsula Private Hospital | Frankston | Victoria | 3199 | Australia |
| Barwon Health, University Hospital Geelong | Geelong | Victoria | 3220 | Australia |
| Cabrini Hospital Malvern | Malvern | Victoria | 3144 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Uniklinikum Salzburg | Salzburg | 5020 | Austria |
| Hanusch kranhenkaus, 3. Medizinische Abteilung | Vienna | 1140 | Austria |
| ZNA Middelheim | Antwerp | 2060 | Belgium |
| ULB Hopital Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Brussel | Brussels | Belgium |
| Chu Ucl Namur Site Godinne | Godinne | 5530 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| AZ Turnhout, Campus St. Elisabeth | Turnhout | 2300 | Belgium |
| Tom Baker Cancer Centre | Calgary | T2N 4N2 | Canada |
| QEII Health Sciences Centre | Halifax | B3H 2Y9 | Canada |
| Eastern Regional Health Authority | St. John's | A1B 3V6 | Canada |
| University Health Network | Toronto | M5G 2M9 | Canada |
| Fakultni nemocnice Olomouc, Hemato-onkologicka klinika | Olomouc | 77520 | Czechia |
| Fakultni nemocnice Ostrava, Klinika hemato-onkologicka | Ostrava | 70852 | Czechia |
| Helsinki University Central Hospital | Helsinki | 00290 | Finland |
| Oulu University Hospital | Oulu | 90220 | Finland |
| CHU Amiens-Picardie | Amiens | 80054 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CHU de Grenoble Alpes | La Tronche | 38700 | France |
| Institut Paoli Calmettes | Marseille | France |
| Hopital Saint Eloi | Montpellier | 34295 | France |
| CHU de Nantes | Nantes | 44000 | France |
| CHU de Nice-l Archet | Nice | 6200 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Institut Gustave Roussy | Paris | 94805 | France |
| Hopital Haut-Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU de Poitiers - Hopital de la Miletrie | Poitiers | 86000 | France |
| CHU de Rennes- Hopital Pontchaillou | Rennes | 35033 | France |
| Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik | Braunschweig | 38114 | Germany |
| Universitatsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin | Düsseldorf | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| Universitat Leipzig | Leipzig | Germany |
| Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin | Stuttgart | 70376 | Germany |
| Hong Kong Sanatorium & Hospital | Hong Kong | Hong Kong |
| Princess Margaret Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| The Chinese University of Hong Kong, Prince of Wales Hospital | Hong Kong | Hong Kong |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika | Budapest | 1125 | Hungary |
| Debreceni Egyetem Klinikai Központ | Debrecen | 4032 | Hungary |
| Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly | Győr | 9024 | Hungary |
| Kaposi Mor Teaching Hospital | Kaposvár | Hungary |
| Bács-Kiskun Megyei Kórház | Kecskemét | 6000 | Hungary |
| SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| University of Pecs | Pécs | 7624 | Hungary |
| Szent Borbála Hospital | Tatabánya | 2800 | Hungary |
| SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo | Alessandria | 15100 | Italy |
| U.O Ematologica- ASST degli Spedali Civili di Brescia | Brescia | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | 50134 | Italy |
| U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| U.O di Ematologia, Ospedale San Gerardo- ASST Monza | Monza | 20052 | Italy |
| S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita | Novara | 28100 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Marche Nord | Pesaro | 61100 | Italy |
| SC di Oncoematologia - Azienda Ospedaliera Santa Maria | Terni | 05100 | Italy |
| SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Southern District Health Board | Dunedin | 9016 | New Zealand |
| Auckland City Hospital | Grafton | 1142 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Midcentral District Health Board | Palmerston North | 4414 | New Zealand |
| Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam | Bergen | 5021 | Norway |
| Akershus University Hospital | Loerenskog | 1478 | Norway |
| Oslo University Hospital | Oslo | 0372 | Norway |
| Stavanger universitetssjukehus | Stavanger | 4068 | Norway |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii | Krakow | 31-501 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli | Lublin | 20090 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | 50-367 | Poland |
| Centro Clinico Academico de Braga, Hospital de Braga, E.P.E | Braga | 4710 | Portugal |
| Champalimaud Foundation | Lisbon | 1400 - 038 | Portugal |
| Hospital da Luz | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar Universitario Sao Joao. E.P.E | Porto | 4200 319 | Portugal |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE | Porto | 4200-072 | Portugal |
| Centro Hospitalar Vila Nova de Gaia/Espinho | Porto | 4430-999 | Portugal |
| Area Sanitaria de Santiago de Compostela y Barbanza. Complejo Hospitalario Universitario de SantiagoD | A Coruña | Spain |
| OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu | Alava | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Institut Catala d'Oncologia Girona | Girona | 17007 | Spain |
| Institut Catala d'Oncologia, Hospital Duran i Reynals | L'Hospitalet de Llobregat | Spain |
| MD Anderson Cancer Center Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia | Madrid | 28046 | Spain |
| Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia | Madrid | Spain |
| Hospital Regional Universitario de Malaga | Málaga | Spain |
| Centro Hospitalar Universitario Sao Joao | Pamplona | 31008 | Spain |
| Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca | Salamanca | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia | Bellinzona | 6500 | Switzerland |
| University of Bern | Bern | 3010 | Switzerland |
| Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie | Zurich | 8091 | Switzerland |
| Hematoloji Bilim Dali, Yenimahalle | Ankara | 06200 | Turkey (Türkiye) |
| Gazi Universitesi Tip Fakultesi | Ankara | 06560 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Cebeci Hastanesi | Ankara | 06620 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu | Inciralt | 35340 | Turkey (Türkiye) |
| Mersin University Medical | Mersin | 33110 | Turkey (Türkiye) |
| Tekirdag Namik Kemal Universitesi Tip Fakultesi | Tekirdağ | 59100 | Turkey (Türkiye) |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| United Lincolnshire Hospital NHS Trust | Boston | PE21 9QS | United Kingdom |
| Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust | Canterbury | CT1 3NG | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 9DU | United Kingdom |
| FG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-treat (ITT) Analysis Set included all participants who were randomized in the study, with treatment assignments designated according to the treatment that participants were randomized to.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Magrolimab + Azacitidine | Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years. |
| BG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
| 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, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Complete Remission (CR) | The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off. | Participants from intent-to-treat analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 31.01 months |
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| Primary | Overall Survival (OS) | OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis. | Participants from intent-to-treat analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization up to 32.62 months |
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| Secondary | Duration of CR (DOCR) | DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. PD is defined as: <5% blasts: ≥50 increase in blasts to >5% blasts,5%-10% blasts: ≥50% increase in blasts to >10% blasts, 10%-20% blasts: ≥50% increase in blasts to >20% blasts,20%-30% blasts: ≥50% increase in blasts to >30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by ≥2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis. | Participants from intent-to-treat analysis set who achieved CR were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization up to 31.01 months |
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| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1. PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by ≥ 50% over pretreatment but still > 5% cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks. Percentages were rounded off. | Participants from intent-to-treat analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 31.01 months |
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| Secondary | Duration of Response (DOR) | DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis. | Participants from intent-to-treat analysis set with objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization up to 31.01 months |
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| Secondary | Red Blood Cell (RBC) Transfusion Independence Rate | RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off. | Participants from intent-to-treat analysis set who were RBC transfusion-dependent at baseline were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 31.01 months |
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| Secondary | Event Free Survival (EFS) | EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first. Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis | Participants from intent-to-treat analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization up to 31.01 months |
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| Secondary | Percentage of Participants With CR in Participants With TP53 Mutation | CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off. | Participants from intent-to-treat analysis set with TP53 mutation were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 31.01 months |
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| Secondary | Minimal Residual Disease (MRD)-Negative Response Rate | The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively. Percentages were rounded off. | Participants from intent-to-treat analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 31.01 months |
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| Secondary | Time to Transformation to AML | Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. Transformation assessments post SCT were included in the analysis.KM estimates were used for analysis. | Participants from intent-to-treat analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization up to 31.01 months |
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| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from randomization to the date of documented DP (including treatment failure by IWG criteria or relapse after PR/CR), or death from any cause, whichever occurs first. Response assessments and deaths post SCT were included in the analysis. Treatment failure is defined as, Death during treatment or disease progression characterized by worsening cytopenia, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment. Relapse after CR or PR = Return to pretreatment bone marrow blast percentage / Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets / Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR, PR and PD are defined in outcome measures 1, 4 and 5 respectively. KM estimates were used for analysis. | Participants from intent-to-treat analysis set were analyzed. | Posted | Median | 95% Confidence Interval | months | From randomization up to 31.01 months |
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| Secondary | Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate | The FACT-Anemia response rate is defined as the percentage of participants who showed clinically meaningful improvement in health-related quality of life (HRQoL) based on the score from the FACT-Anemia instrument prior to initiation of any new anticancer therapy, including SCT. The minimal clinically meaningful difference of 7.0 was used as cutoff for clinically meaningful improvement. The FACT-Anemia instrument consists of 5 subscales, including physical well-being, emotional well-being, functional well-being, social well-being, and anemia symptoms. Each subscale measures items on a 5-point Likert scale from 0 to 4, where 0 = not at all and 4 = very much. The subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest quality of life (QOL) and 100 denotes the highest QOL. Percentages were rounded off. | Participants from intent-to-treat analysis set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to week 136 |
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| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) | TEAE's are defined as any AEs with an onset date on or after the study drug start date, no later than 70 days after study drug last dose date or day before initiation of new anticancer therapy including SCT. If AE onset date is on or before last dose date, it is considered as TEAE regardless of start of new anticancer therapy. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution. An event is considered "serious", if it results death, life-threatening, inpatient or prolongation hospitalization, incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, and important medical events. | Participants from safety analysis set with data available were analyzed. The safety analysis set included all randomized participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received. | Posted | Number | percentage of participants | First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years) |
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| Secondary | Serum Concentration of Magrolimab | Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of study treatment; thereafter, pretreatment assessments are to be collected within 24 hours prior to study treatment administration. | Pharmacokinetic (PK) analysis set included all participants who took at least 1 dose of magrolimab and had at least 1 measurable post-treatment serum concentration of magrolimab. Participants with data available at the given timepoint were analyzed. | Posted | Mean | Standard Deviation | μg/mL | Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336 |
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| Secondary | Percentage of Participants With Positive Anti-magrolimab Antibodies | Percentages were rounded off. | Participants in Immunogenicity Analysis Set with at least 1 baseline anti-drug antibody (ADA) sample and at least post-treatment ADA Sample were analyzed. Immunogenicity Analysis Set includes participants who took at least 1 dose of magrolimab and have at least 1 reported ADA result. | Posted | Number | percentage of participants | Up to 72 hours before administration of any treatment at Day 1, Cycle 1; within 24 hours prior to any study drug administration at Day 1 of Cycles 2, 3, 5, 7, 10, and 13 and End of Treatment (± 7 Days after last study drug dose); Cycle length is 28 Days |
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Up to 135.9 weeks plus 70 days (Up to 2.8 years)
All cause mortality: The intent-to-treat (ITT) analysis set included all participants who were randomized in the study, with treatment assignments designated according to the treatment that participants were randomized to.
Adverse Events: The safety analysis set included all randomized participants who received at least 1 dose of any study treatment, with treatment assignments 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 + Azacitidine | Participants received the following magrolimab and azacitidine dosing regimens: Magrolimab was administered as an intravenous (IV) priming dose of 1 mg/kg on Days 1 and 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Following priming dose, magrolimab maintenance dose of 30 mg/kg was administered on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.6 years. | 145 | 268 | 189 | 263 | 246 | 263 |
| EG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. | 132 | 271 | 136 | 264 | 256 | 264 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Cold type haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Extravascular haemolysis | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Haemolysis | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Red blood cell agglutination | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Splenic infarction | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Splenomegaly | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Stress cardiomyopathy | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 26.0. | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Anal haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Anal ulcer | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Mouth swelling | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Chills | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Death | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0. | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Injection site irritation | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Localised oedema | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Pain | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Swelling face | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA 26.0. | Systematic Assessment |
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| Acute hepatic failure | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.0. | Systematic Assessment |
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| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 26.0. | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 26.0. | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Arthritis infective | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Covid-19 pneumonia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Empyema | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Hcov-oc43 infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Incision site cellulitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Injection site cellulitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Lymph node tuberculosis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Mucormycosis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Necrotising fasciitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Neutropenic infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Perirectal abscess | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pneumonia fungal | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Post procedural cellulitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Pseudomonal bacteraemia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Thrombophlebitis septic | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Escherichia test positive | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Muscle mass | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0. | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0. | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Iiird nerve paralysis | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Sigmoid sinus thrombosis | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0. | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0. | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0. | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0. | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0. | 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: First Interim Analyses | Jul 29, 2022 | Feb 13, 2024 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Second Interim and Final Analyses | Mar 6, 2023 | Feb 13, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629291 | magrolimab |
| 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
| >=65 years |
|
| Male |
|
| Non Hispanic or Latino |
|
| Unknown |
|
| Not Reported / Missing |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian Or Other Pacific Islander |
|
| White |
|
| Multiple |
|
| Not reported / Missing |
|
| Hungary |
|
| United States |
|
| United Kingdom |
|
| Switzerland |
|
| Portugal |
|
| Spain |
|
| New Zealand |
|
| Canada |
|
| Turkey |
|
| Belgium |
|
| Norway |
|
| Finland |
|
| Poland |
|
| Italy |
|
| France |
|
| Australia |
|
| Germany |
|
|
|
|
| OG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
|
|
| OG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered as an IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine:
Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter.
Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.
The maximum duration of treatment was up to approximately 2.5 years.
|
|
|
|
|
|
| OG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
|
|
|
| OG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
|
|
|
| OG001 | Placebo + Azacitidine | Participants received the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo was administered IV on Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine 75 mg/m^2 was administered either subcutaneously (SC) or IV on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle. The maximum duration of treatment was up to approximately 2.5 years. |
|
|
|
|
| Participants |
|
|