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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004479-11 | EudraCT Number |
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In December 2023, Novartis decided to terminate the sabatolimab clinical development program early after Phase II (MDS1) and Phase III (MDS2) studies failed to meet their primary objectives. The termination was not due to safety concerns.
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This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy.
The 2 primary objectives were as follows:
To determine if MBG453 combined with standard HMA therapy improved complete remission in subjects with intermediate, high, or very high risk MDS.
To determine if MBG453 combined with standard HMA therapy improved progression free survival (PFS) in subjects with intermediate, high or very high risk MDS.
This Phase II study was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine, as per investigators' choice based on local standard of care (SOC)) in adult subjects with IPSS-R intermediate, high or very high risk MDS not eligible for HSCT or intensive chemotherapy. A total of 127 subjects were randomized in a 1:1 ratio to treatment arms as follows:
The randomization was stratified by 2 stratification factors: a) HMA (decitabine or azacitidine) selected by the investigator as per the local SOC and b) IPSS-R prognostic risk categories (intermediate, high or very high) at randomization. Crossover between treatment arms was not permitted at any time during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBG453 + hypomethylating agents | Experimental | Patients are taking MBG453 plus hypomethylating agents |
|
| Placebo + hypomethylating agents | Placebo Comparator | Patients are taking placebo plus hypomethylating agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBG453 | Drug | MBG453 is being administered i.v. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate | CR: where the Bone marrow: ≤ 5% blasts with normal maturation of all cell lineages and Peripheral blood: where Hgb ≥ 10 g/dL AND Platelets ≥ 100*109/L AND Neutrophils ≥ 1.0*109/L AND Peripheral blasts 0%. Modified response criteria According to International Working Group (IWG) and as per World Health Organization (WHO) criteria for Myelodysplastic syndromes (MDS) as per investigator assessment. | average of 7 months |
| Progression Free Survival (PFS) | PFS is defined as time from randomization to disease progression (including transformation to acute leukemia per WHO 2016 classification), relapse from CR according to IWG-MDS or death due to any cause, whichever occurs first, as per investigator assessment. | approx. 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) - Final PFS | PFS isdefined as time from randomization to disease progression (including transformation to acute leukemia per WHO 2016 classification), relapse from CR according to IWG-MDS or death due to any cause. This is an update of the Primary Outcome Measure PFS with data collected after assessment of the primary results. | approx. 48 months |
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Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Age ≥ 18 years at the date of signing the informed consent form (ICF)-. Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R):
Not eligible at the time of screening, for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
Not eligible at the time of screening, for hematopoietic stem-cell transplantation (HSCT) according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Of Hope National Med Center | Duarte | California | 91010 | United States | ||
| City of Hope National Medical Center Medical Oncology & Therapeutic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38065203 | Derived | Zeidan AM, Ando K, Rauzy O, Turgut M, Wang MC, Cairoli R, Hou HA, Kwong YL, Arnan M, Meers S, Pullarkat V, Santini V, Malek K, Kiertsman F, Niolat J, Ramos PM, Menssen HD, Fenaux P, Miyazaki Y, Platzbecker U. Sabatolimab plus hypomethylating agents in previously untreated patients with higher-risk myelodysplastic syndromes (STIMULUS-MDS1): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Haematol. 2024 Jan;11(1):e38-e50. doi: 10.1016/S2352-3026(23)00333-2. Epub 2023 Dec 5. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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47 centers across 17 countries enrolled subjects in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MBG453 + Hypomethylating Agents (HMA) | Participants were taking MBG453 plus hypomethylating agents |
| FG001 | Placebo + Hypomethylating Agents (HMA) | Participants were taking placebo plus hypomethylating agents |
| 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 | Sep 2, 2021 | Apr 24, 2023 |
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| Placebo | Drug | Placebo is being administered i.v. |
|
| Hypomethylating agents | Drug | Decitabine is being administered i.v. Azacitidine is being administered i.v or s.c. |
|
| Overall Survival (OS) | Time from randomization to death due to any cause | approx. 48 months |
| Event-free Survival (EFS) | EFS is defined as the time from randomization to lack of reaching complete response (CR) within the first 6 months, relapse from CR or death due to any cause, whichever occurs first. CR and relapse from CR were defined according to International Working Group (IWG) for Myelodysplastic Syndromes (MDS) as per Investigator assessment. For participants not reaching CR within the first 6 months, an EFS event at day 1 was considered. | approx. 48 months |
| Leukemia-free Survival (LFS) | LFS is defined as the time from randomization to ≥ 20% blasts in bone marrow/peripheral blood (per World Health Organization (WHO) 2016 classification) or diagnosis of extramedullary acute leukemia or death due to any cause. | approx. 48 months |
| Response Rate of Complete Remission (CR)/Marrow Complete Remission (mCR)/Partial Remission (PR)/Hematopoietic Improvement (HI)) | Percentage of complete remission (CR)/marrow Complete Remission (mCR)/partial remission (PR) & Hematological improvement (HI) as per investigator assessment according to IWG-MDS. CR: where the Bone marrow: ≤ 5% blasts with normal maturation of all cell lineages and Peripheral blood: where Hgb ≥ 10 g/dL AND Platelets ≥ 100*109/L AND Neutrophils ≥ 1.0*109/L AND Peripheral blasts 0%. mCR: where the Bone marrow ≤5% blasts and blast count decrease by ≥50% compared to baseline with or without improved blood counts or with or without transfusions. PR: All CR criteria except bone marrow: ≥50% decrease from baseline in blasts in bone marrow AND blast count in bone marrow >5%. HI: restoration or enhancement of the function of the body's blood cell-producing system that must last as least 8 weeks. HI definition is based on modified Hematological Improvement per IWG-MDS criteria in MDS & is the combination of Erythroid response (HI-E), Platelet response (HI-P) & Neutrophil response (HI-N). | approx. 32 months |
| Duration of Complete Remission | Duration of complete response is the time from the date of the first documented CR to the date of first documented relapse from CR or death due to any cause, whichever occurs first. | approx. 48 months |
| Time to Complete Remission | Time from randomization to the first documented CR | Average of 7 months |
| Percent of Participants Who Are Red Blood Cells (RBC)/Platelets Transfusion Independent After Randomization as Per IWG-MDS | Improvement in RBC/platelets transfusion independence. RBC/platelets transfusion independence rate is defined as the percentage of participants having received no RBC/platelets transfusions during at least 8 consecutive weeks after randomization. | approx. 48 months |
| Red Blood Cells (RBC) Transfusion Independence Duration After Randomization | The total duration of all transfusion independence periods is the sum of each period of the transfusion independence. RBC transfusions independence period is defined as the period for which participants having received no RBC transfusions during at least 8 consecutive weeks after randomization. | approx. 48 months |
| Platelets Transfusion Independence Duration After Randomization | The total duration of all transfusion independence periods is the sum of each period of the transfusion independence. Platelets transfusions independence period is defined as the period for which participants having received no platelets transfusions during at least 8 consecutive weeks after randomization. | approx. 48 months |
| Serum Concentrations for MBG453 | Pharmacokinetics (PK) of MBG453 when given in combination with hypomethylating agents (HMA) | 0hr pre-dose on Day 8 of each cycle until cycle 6 and on Day 8 of cycles 9, 12, 18 and 24, 2hr post-dose on Day 8 of C1 and C3, EOT (approx. 48 months) and up to 150 day of the safety follow up period; 1 cycle = 28 days |
| Immunogenicity (IG) of MBG453 When Given in Combination of Hypomethylating Agents: ADA Prevalence | Number of participants with at least one sample meeting the criteria at baseline. Anti-drug Antibody (ADA) prevalence equals ADA-positive at baseline. | at baseline |
| Immunogenicity of MBG453 When Given in Combination of Hypomethylating Agents: ADA-positive Participants | Anti-drug Antibody (ADA) positive participants on-treatment was calculated as the number of participants with at least 1 on-treatment ADA-positive sample divided by the number of participants with a determinant baseline IG sample and at least one determinant post-baseline IG sample. | approx. 48 months |
| Duarte |
| California |
| 91010 |
| United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| The Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Ohio State Comprehensive Cancer Center James Cancer Hospital | Columbus | Ohio | 73210 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75251 | United States |
| Novartis Investigative Site | Vienna | 1140 | Austria |
| Novartis Investigative Site | Brasschaat | 2930 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1J 1Z4 | Canada |
| Novartis Investigative Site | Brno | 625 00 | Czechia |
| Novartis Investigative Site | Prague | 128 08 | Czechia |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Leipzig | Saxony | 04103 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Alexandroupoli | 681 00 | Greece |
| Novartis Investigative Site | Larissa | 411 10 | Greece |
| Novartis Investigative Site | Pátrai | 265 04 | Greece |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Debrecen | Hajdu Bihar Megye | 4032 | Hungary |
| Novartis Investigative Site | Nyíregyháza | 4400 | Hungary |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Reggio Calabria | RC | 89124 | Italy |
| Novartis Investigative Site | Roma | RM | 00133 | Italy |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Fukushima | Fukushima | 960 1295 | Japan |
| Novartis Investigative Site | Isehara | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-0008 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 983 8520 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8501 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8677 | Japan |
| Novartis Investigative Site | Gifu | 500 8513 | Japan |
| Novartis Investigative Site | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Novartis Investigative Site | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Málaga | 29010 | Spain |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Samsun | Atakum | 55200 | Turkey (Türkiye) |
| Novartis Investigative Site | Köseköy | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35100 | Turkey (Türkiye) |
| Novartis Investigative Site | Manchester | M20 2BX | United Kingdom |
| Treated |
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| Not treated |
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| Discontinued from treatment |
|
| COMPLETED | Completed = Completed treatment |
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| NOT COMPLETED |
|
|
Full Analysis Set (FAS): All randomized subjects were included in the FAS (intent-to-treat population) Subject data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. Efficacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | MBG453 + Hypomethylating Agents (HMA) | Participants were taking MBG453 plus hypomethylating agents |
| BG001 | Placebo + Hypomethylating Agents (HMA) | Participants were taking placebo plus hypomethylating agents |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Complete Remission (CR) Rate | CR: where the Bone marrow: ≤ 5% blasts with normal maturation of all cell lineages and Peripheral blood: where Hgb ≥ 10 g/dL AND Platelets ≥ 100*109/L AND Neutrophils ≥ 1.0*109/L AND Peripheral blasts 0%. Modified response criteria According to International Working Group (IWG) and as per World Health Organization (WHO) criteria for Myelodysplastic syndromes (MDS) as per investigator assessment. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population) Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | average of 7 months |
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| Primary | Progression Free Survival (PFS) | PFS is defined as time from randomization to disease progression (including transformation to acute leukemia per WHO 2016 classification), relapse from CR according to IWG-MDS or death due to any cause, whichever occurs first, as per investigator assessment. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Median | 95% Confidence Interval | months | approx. 32 months |
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| Secondary | Progression Free Survival (PFS) - Final PFS | PFS isdefined as time from randomization to disease progression (including transformation to acute leukemia per WHO 2016 classification), relapse from CR according to IWG-MDS or death due to any cause. This is an update of the Primary Outcome Measure PFS with data collected after assessment of the primary results. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Median | 95% Confidence Interval | months | approx. 48 months |
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| Secondary | Overall Survival (OS) | Time from randomization to death due to any cause | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent to treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Median | 95% Confidence Interval | Months | approx. 48 months |
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| Secondary | Event-free Survival (EFS) | EFS is defined as the time from randomization to lack of reaching complete response (CR) within the first 6 months, relapse from CR or death due to any cause, whichever occurs first. CR and relapse from CR were defined according to International Working Group (IWG) for Myelodysplastic Syndromes (MDS) as per Investigator assessment. For participants not reaching CR within the first 6 months, an EFS event at day 1 was considered. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent to treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Median | 95% Confidence Interval | Months | approx. 48 months |
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| Secondary | Leukemia-free Survival (LFS) | LFS is defined as the time from randomization to ≥ 20% blasts in bone marrow/peripheral blood (per World Health Organization (WHO) 2016 classification) or diagnosis of extramedullary acute leukemia or death due to any cause. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent to treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Median | 95% Confidence Interval | Months | approx. 48 months |
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| Secondary | Response Rate of Complete Remission (CR)/Marrow Complete Remission (mCR)/Partial Remission (PR)/Hematopoietic Improvement (HI)) | Percentage of complete remission (CR)/marrow Complete Remission (mCR)/partial remission (PR) & Hematological improvement (HI) as per investigator assessment according to IWG-MDS. CR: where the Bone marrow: ≤ 5% blasts with normal maturation of all cell lineages and Peripheral blood: where Hgb ≥ 10 g/dL AND Platelets ≥ 100*109/L AND Neutrophils ≥ 1.0*109/L AND Peripheral blasts 0%. mCR: where the Bone marrow ≤5% blasts and blast count decrease by ≥50% compared to baseline with or without improved blood counts or with or without transfusions. PR: All CR criteria except bone marrow: ≥50% decrease from baseline in blasts in bone marrow AND blast count in bone marrow >5%. HI: restoration or enhancement of the function of the body's blood cell-producing system that must last as least 8 weeks. HI definition is based on modified Hematological Improvement per IWG-MDS criteria in MDS & is the combination of Erythroid response (HI-E), Platelet response (HI-P) & Neutrophil response (HI-N). | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 32 months |
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| Secondary | Duration of Complete Remission | Duration of complete response is the time from the date of the first documented CR to the date of first documented relapse from CR or death due to any cause, whichever occurs first. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. Analysis was done on participants who experienced a complete remission. | Posted | Median | 95% Confidence Interval | Months | approx. 48 months |
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| Secondary | Time to Complete Remission | Time from randomization to the first documented CR | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Median | 95% Confidence Interval | Months | Average of 7 months |
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| Secondary | Percent of Participants Who Are Red Blood Cells (RBC)/Platelets Transfusion Independent After Randomization as Per IWG-MDS | Improvement in RBC/platelets transfusion independence. RBC/platelets transfusion independence rate is defined as the percentage of participants having received no RBC/platelets transfusions during at least 8 consecutive weeks after randomization. | Full Analysis Set (FAS): All randomized subjects were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | approx. 48 months |
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| Secondary | Red Blood Cells (RBC) Transfusion Independence Duration After Randomization | The total duration of all transfusion independence periods is the sum of each period of the transfusion independence. RBC transfusions independence period is defined as the period for which participants having received no RBC transfusions during at least 8 consecutive weeks after randomization. | Full Analysis Set (FAS): All randomized subjects were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. Analysis done only on participants with at least one period of RBC transfusion independence post-baseline. | Posted | Median | Inter-Quartile Range | Weeks | approx. 48 months |
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| Secondary | Platelets Transfusion Independence Duration After Randomization | The total duration of all transfusion independence periods is the sum of each period of the transfusion independence. Platelets transfusions independence period is defined as the period for which participants having received no platelets transfusions during at least 8 consecutive weeks after randomization. | Full Analysis Set (FAS): All randomized participants were included in the FAS (intent-to-treat population). Participant data in the FAS were analyzed according to the treatment and stratum they were assigned to when they were randomized. Analysis done only on participants with at least one period of platelets transfusion independence post-baseline. | Posted | Median | Inter-Quartile Range | Weeks | approx. 48 months |
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| Secondary | Serum Concentrations for MBG453 | Pharmacokinetics (PK) of MBG453 when given in combination with hypomethylating agents (HMA) | Pharmacokinetic analysis set (PAS) included all participants in the Safety Set in the MBG453 arm only, who had at least one evaluable PK concentration. | Posted | Mean | Standard Deviation | micro gram/mL | 0hr pre-dose on Day 8 of each cycle until cycle 6 and on Day 8 of cycles 9, 12, 18 and 24, 2hr post-dose on Day 8 of C1 and C3, EOT (approx. 48 months) and up to 150 day of the safety follow up period; 1 cycle = 28 days |
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| Secondary | Immunogenicity (IG) of MBG453 When Given in Combination of Hypomethylating Agents: ADA Prevalence | Number of participants with at least one sample meeting the criteria at baseline. Anti-drug Antibody (ADA) prevalence equals ADA-positive at baseline. | The immunogenicity prevalence set included all participants in the full analysis set with a determinant baseline IG sample. | Posted | Count of Participants | Participants | at baseline |
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| Secondary | Immunogenicity of MBG453 When Given in Combination of Hypomethylating Agents: ADA-positive Participants | Anti-drug Antibody (ADA) positive participants on-treatment was calculated as the number of participants with at least 1 on-treatment ADA-positive sample divided by the number of participants with a determinant baseline IG sample and at least one determinant post-baseline IG sample. | Included all participants in the immunogenicity prevalence set with a determinant baseline IG sample and at least one determinant post-baseline IG sample. | Posted | Count of Participants | Participants | approx. 48 months |
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| Post-Hoc | All Collected Deaths | Deaths were collected from randomization until end of trial, approx. 48 months. | Clinical database population: All randomized participants: participants who died before treatment, during treatment and post-treatment. | Posted | Number | Participants | from randomization until end of trial, approx. 48 months |
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Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 51.84 months (sabatolimab plus HMA) and 45.11 months (placebo + HMA). Deaths were collected from randomization until end of trial, approx. 48 months.
Adverse Event: Any sign or symptom that occurs during the study treatment + 30 days post treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MBG453 + Hypomethylating Agents (HMA) | Participants were taking MBG453 plus hypomethylating agents | 45 | 62 | 38 | 62 | 61 | 62 |
| EG001 | Placebo + Hypomethylating Agents (HMA) | Participants were taking placebo plus hypomethylating agents | 53 | 63 | 43 | 63 | 63 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperleukocytosis | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Chills | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Condition aggravated | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Death | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Disease progression | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Gingival abscess | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Febrile nonhaemolytic transfusion reaction | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lip squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of the hypopharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Oedema | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Pain | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| SARS-CoV-2 test negative | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
|
A total of 127 subjects were randomized (65 to sabatolimab (S)+HMA arm, 62 to placebo (P)+HMA arm. However, only 125 subjects were treated (64 in S+HMA arm, 61 in P+HMA arm). Two subjects in S+HMA arm received only HMA, and, as a result, were reported in P+HMA arm in the safety dataset. Therefore, the safety dataset included a total of 62 subjects in the S+HMA arm & 63 subjects in the P+HMA arm.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2021 | Apr 24, 2023 | SAP_001.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 |
|---|---|
| C000723550 | sabatolimab |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Black or African American |
|
| Unknown |
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| Placebo + Hypomethylating Agents (HMA) |
Participants were taking placebo plus hypomethylating agents |
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