Trial Outcomes & Findings for A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS). (NCT NCT03946670)

NCT ID: NCT03946670

Last Updated: 2026-01-13

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 127 participants
• Primary outcome timeframe: average of 7 months
• Results posted on: 2026-01-13

Participant Flow

47 centers across 17 countries enrolled subjects in this study.

Participant milestones

Measure	MBG453 + Hypomethylating Agents (HMA) Participants were taking MBG453 plus hypomethylating agents	Placebo + Hypomethylating Agents (HMA) Participants were taking placebo plus hypomethylating agents
Overall Study STARTED	65	62
Overall Study Treated	64	61
Overall Study Not treated	1	1
Overall Study Discontinued from treatment	64	61
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	65	62

Reasons for withdrawal

Measure	MBG453 + Hypomethylating Agents (HMA) Participants were taking MBG453 plus hypomethylating agents	Placebo + Hypomethylating Agents (HMA) Participants were taking placebo plus hypomethylating agents
Overall Study Progressive Disease	34	27
Overall Study Adverse Event	7	10
Overall Study Physician Decision	6	5
Overall Study Death	5	8
Overall Study Hematopoietic stem cell transplantation (HSCT) Planned	5	6
Overall Study Subject Decision	4	5
Overall Study Study Terminated By Sponsor	2	0
Overall Study New Therapy For Study Indication	1	0
Overall Study Not Treated	1	1

Baseline Characteristics

A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).

Baseline characteristics by cohort

Measure	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	Total n=127 Participants Total of all reporting groups
Race/Ethnicity, Customized Black or African American	0 Participants n=210 Participants	1 Participants n=19 Participants	1 Participants n=123 Participants
Age, Continuous	71.9 Years STANDARD_DEVIATION 6.70 • n=210 Participants	71.3 Years STANDARD_DEVIATION 9.64 • n=19 Participants	71.6 Years STANDARD_DEVIATION 8.24 • n=123 Participants
Sex: Female, Male Female	24 Participants n=210 Participants	17 Participants n=19 Participants	41 Participants n=123 Participants
Sex: Female, Male Male	41 Participants n=210 Participants	45 Participants n=19 Participants	86 Participants n=123 Participants
Race/Ethnicity, Customized White	44 Participants n=210 Participants	33 Participants n=19 Participants	77 Participants n=123 Participants
Race/Ethnicity, Customized Asian	17 Participants n=210 Participants	25 Participants n=19 Participants	42 Participants n=123 Participants
Race/Ethnicity, Customized Unknown	4 Participants n=210 Participants	3 Participants n=19 Participants	7 Participants n=123 Participants

PRIMARY outcome

Timeframe: average of 7 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Complete Remission (CR) Rate	17.7 Percentage of participants Interval 9.2 to 29.5	21.5 Percentage of participants Interval 12.3 to 33.5

PRIMARY outcome

Timeframe: approx. 32 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Progression Free Survival (PFS)	8.48 months Interval 6.93 to 11.3	11.07 months Interval 7.62 to 17.61

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Progression Free Survival (PFS) - Final PFS	8.48 months Interval 6.93 to 11.3	11.07 months Interval 7.62 to 16.59

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

Time from randomization to death due to any cause

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Overall Survival (OS)	18.00 Months Interval 13.11 to 25.43	19.12 Months Interval 13.9 to 30.03

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Event-free Survival (EFS)	0.03 Months Interval 0.0 to NA: Because the survival curve crossed below 50% almost immediately, leaving no earlier time point to support calculation and remained below 50% afterward, the lower confidence limit was set to 0 and the upper confidence limits could not be estimable.	0.03 Months Interval 0.0 to NA: Because the survival curve crossed below 50% almost immediately, leaving no earlier time point to support calculation and remained below 50% afterward, the lower confidence limit was set to 0 and the upper confidence limits could not be estimable.

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Leukemia-free Survival (LFS)	13.63 Months Interval 9.82 to 21.16	16.82 Months Interval 8.8 to 28.58

SECONDARY outcome

Timeframe: approx. 32 months

Population: 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.

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).

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Response Rate of Complete Remission (CR)/Marrow Complete Remission (mCR)/Partial Remission (PR)/Hematopoietic Improvement (HI))	61.3 Percentage of participants Interval 48.1 to 73.4	67.7 Percentage of participants Interval 54.9 to 78.8

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=13 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=15 Participants Participants were taking MBG453 plus hypomethylating agents
Duration of Complete Remission	9.23 Months Interval 5.09 to 17.97	17.97 Months Interval 10.87 to 27.17

SECONDARY outcome

Timeframe: Average of 7 months

Population: 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.

Time from randomization to the first documented CR

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Time to Complete Remission	NA Months NA: Not estimable as there were insufficient number of participants with events.	NA Months NA: Not estimable as there were insufficient number of participants with events.

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
Percent of Participants Who Are Red Blood Cells (RBC)/Platelets Transfusion Independent After Randomization as Per IWG-MDS Red blood cells (RBC)	64.5 Percentage of participants Interval 51.3 to 76.3	60.0 Percentage of participants Interval 47.1 to 72.0
Percent of Participants Who Are Red Blood Cells (RBC)/Platelets Transfusion Independent After Randomization as Per IWG-MDS Platelets	74.2 Percentage of participants Interval 61.5 to 84.5	73.8 Percentage of participants Interval 61.5 to 84.0

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=40 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=39 Participants Participants were taking MBG453 plus hypomethylating agents
Red Blood Cells (RBC) Transfusion Independence Duration After Randomization	36.71 Weeks Interval 20.29 to 65.36	46.29 Weeks Interval 22.86 to 113.0

SECONDARY outcome

Timeframe: approx. 48 months

Population: 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.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=46 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=48 Participants Participants were taking MBG453 plus hypomethylating agents
Platelets Transfusion Independence Duration After Randomization	45.29 Weeks Interval 25.14 to 80.0	44.36 Weeks Interval 22.29 to 107.43

SECONDARY outcome

Timeframe: 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

Population: Pharmacokinetic analysis set (PAS) included all participants in the Safety Set in the MBG453 arm only, who had at least one evaluable PK concentration.

Pharmacokinetics (PK) of MBG453 when given in combination with hypomethylating agents (HMA)

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=49 Participants Participants were taking MBG453 plus hypomethylating agents
Serum Concentrations for MBG453 Cycle (C) 1 Day (D) 8 at 0 hour (hr) (pre-dose)	—	0 micro gram/mL Standard Deviation 0
Serum Concentrations for MBG453 C1 D8 at 2 hr	—	103 micro gram/mL Standard Deviation 72.4
Serum Concentrations for MBG453 C2 D8 at 0 hr (pre-dose)	—	38.8 micro gram/mL Standard Deviation 20.5
Serum Concentrations for MBG453 C3 D8 at 0 hr (pre-dose)	—	57.5 micro gram/mL Standard Deviation 32.1
Serum Concentrations for MBG453 C3 D8 at 2 hr	—	149 micro gram/mL Standard Deviation 49.6
Serum Concentrations for MBG453 C4 D8 at 0 hr (pre-dose)	—	70.7 micro gram/mL Standard Deviation 37.6
Serum Concentrations for MBG453 C5 D8 at 0 hr (pre-dose)	—	76.7 micro gram/mL Standard Deviation 38.4
Serum Concentrations for MBG453 C6 D8 at 0 hr (pre-dose)	—	85.0 micro gram/mL Standard Deviation 37.7
Serum Concentrations for MBG453 C9 D8 at 0 hr (pre-dose)	—	97.3 micro gram/mL Standard Deviation 49.3
Serum Concentrations for MBG453 C12 D8 at 0 hr (pre-dose)	—	103 micro gram/mL Standard Deviation 43.0
Serum Concentrations for MBG453 C18 D8 at 0 hr (pre-dose)	—	97.7 micro gram/mL Standard Deviation 42.4
Serum Concentrations for MBG453 C24 D8 at 0 hr (pre-dose)	—	134 micro gram/mL Standard Deviation 39.3
Serum Concentrations for MBG453 End of treatment (EOT)	—	50.0 micro gram/mL Standard Deviation 43.8
Serum Concentrations for MBG453 30 D Safety follow-up (f/u)	—	44.4 micro gram/mL Standard Deviation 46.6
Serum Concentrations for MBG453 150 D Safety f/u	—	0 micro gram/mL Standard Deviation 0

SECONDARY outcome

Timeframe: at baseline

Population: The immunogenicity prevalence set included all participants in the full analysis set with a determinant baseline IG sample.

Number of participants with at least one sample meeting the criteria at baseline. Anti-drug Antibody (ADA) prevalence equals ADA-positive at baseline.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=61 Participants Participants were taking MBG453 plus hypomethylating agents
Immunogenicity (IG) of MBG453 When Given in Combination of Hypomethylating Agents: ADA Prevalence	—	11 Participants

SECONDARY outcome

Timeframe: approx. 48 months

Population: Included all participants in the immunogenicity prevalence set with a determinant baseline IG sample and at least one determinant post-baseline IG sample.

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.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=60 Participants Participants were taking MBG453 plus hypomethylating agents
Immunogenicity of MBG453 When Given in Combination of Hypomethylating Agents: ADA-positive Participants	—	6 Participants

POST_HOC outcome

Timeframe: from randomization until end of trial, approx. 48 months

Population: Clinical database population: All randomized participants: participants who died before treatment, during treatment and post-treatment.

Deaths were collected from randomization until end of trial, approx. 48 months.

Outcome measures

Measure	Placebo + Hypomethylating Agents (HMA) n=62 Participants Participants were taking placebo plus hypomethylating agents	MBG453 + Hypomethylating Agents (HMA) n=65 Participants Participants were taking MBG453 plus hypomethylating agents
All Collected Deaths Pre-treatment deaths	1 Participants	0 Participants
All Collected Deaths On-treatment deaths	13 Participants	5 Participants
All Collected Deaths Post-treatment deaths	39 Participants	40 Participants
All Collected Deaths Total deaths	53 Participants	45 Participants

Adverse Events

MBG453 + Hypomethylating Agents (HMA)

Serious events: 38 serious events

Other events: 61 other events

Deaths: 45 deaths

Placebo + Hypomethylating Agents (HMA)

Serious events: 43 serious events

Other events: 63 other events

Deaths: 53 deaths

Serious adverse events

Measure	MBG453 + Hypomethylating Agents (HMA) n=62 participants at risk Participants were taking MBG453 plus hypomethylating agents	Placebo + Hypomethylating Agents (HMA) n=63 participants at risk Participants were taking placebo plus hypomethylating agents
Blood and lymphatic system disorders Anaemia	3.2% 2/62 • 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.	3.2% 2/63 • 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.
Blood and lymphatic system disorders Febrile neutropenia	25.8% 16/62 • 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.	22.2% 14/63 • 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.
Blood and lymphatic system disorders Hyperleukocytosis	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Blood and lymphatic system disorders Neutropenia	4.8% 3/62 • 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.	4.8% 3/63 • 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.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Cardiac disorders Atrial fibrillation	0.00% 0/62 • 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.	3.2% 2/63 • 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.
Cardiac disorders Cardiac arrest	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Cardiac disorders Cardiac failure	1.6% 1/62 • 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.	1.6% 1/63 • 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.
Cardiac disorders Myocardial infarction	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Gastrointestinal disorders Abdominal pain upper	1.6% 1/62 • 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.	1.6% 1/63 • 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.
Gastrointestinal disorders Anal haemorrhage	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Gastrointestinal disorders Colitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Gastrointestinal disorders Diarrhoea	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Gastrointestinal disorders Enteritis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Gastrointestinal disorders Enterocolitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/62 • 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.	3.2% 2/63 • 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.
Gastrointestinal disorders Pancreatitis acute	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/62 • 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.	1.6% 1/63 • 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.
General disorders and administration site conditions Asthenia	1.6% 1/62 • 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.	0.00% 0/63 • 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.
General disorders and administration site conditions Chills	0.00% 0/62 • 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.	1.6% 1/63 • 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.
General disorders and administration site conditions Condition aggravated	0.00% 0/62 • 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.	1.6% 1/63 • 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.
General disorders and administration site conditions Death	0.00% 0/62 • 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.	1.6% 1/63 • 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.
General disorders and administration site conditions Disease progression	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Bacteraemia	0.00% 0/62 • 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.	4.8% 3/63 • 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.
General disorders and administration site conditions Fatigue	0.00% 0/62 • 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.	1.6% 1/63 • 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.
General disorders and administration site conditions Gait disturbance	0.00% 0/62 • 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.	1.6% 1/63 • 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.
General disorders and administration site conditions Pyrexia	1.6% 1/62 • 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.	14.3% 9/63 • 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.
Hepatobiliary disorders Cholecystitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Immune system disorders Immune reconstitution inflammatory syndrome	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Biliary sepsis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Bronchopulmonary aspergillosis	1.6% 1/62 • 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.	1.6% 1/63 • 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.
Infections and infestations COVID-19	3.2% 2/62 • 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.	3.2% 2/63 • 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.
Infections and infestations COVID-19 pneumonia	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Cellulitis	0.00% 0/62 • 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.	3.2% 2/63 • 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.
Infections and infestations Clostridium difficile colitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Dermo-hypodermitis	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Infections and infestations Diverticulitis	0.00% 0/62 • 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.	3.2% 2/63 • 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.
Infections and infestations Encephalitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Enterococcal bacteraemia	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Epiglottitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Escherichia bacteraemia	1.6% 1/62 • 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.	3.2% 2/63 • 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.
Infections and infestations Gastrointestinal bacterial infection	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Infections and infestations Gingival abscess	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Influenza	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Intervertebral discitis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Klebsiella bacteraemia	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Pneumonia	14.5% 9/62 • 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.	17.5% 11/63 • 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.
Infections and infestations Pneumonia fungal	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Pseudomonal bacteraemia	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Infections and infestations Pulmonary tuberculosis	0.00% 0/62 • 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.	3.2% 2/63 • 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.
Infections and infestations Respiratory tract infection	3.2% 2/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Sepsis	6.5% 4/62 • 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.	12.7% 8/63 • 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.
Infections and infestations Septic shock	3.2% 2/62 • 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.	6.3% 4/63 • 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.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Staphylococcal infection	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Infections and infestations Tooth infection	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Urinary tract infection	4.8% 3/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Urinary tract infection bacterial	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Infections and infestations Urosepsis	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Injury, poisoning and procedural complications Fall	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Injury, poisoning and procedural complications Febrile nonhaemolytic transfusion reaction	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Injury, poisoning and procedural complications Infusion related reaction	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Investigations General physical condition abnormal	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Investigations Haemoglobin decreased	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Investigations Neutrophil count decreased	1.6% 1/62 • 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.	1.6% 1/63 • 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.
Investigations Platelet count decreased	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Investigations White blood cell count decreased	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Metabolism and nutrition disorders Decreased appetite	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Metabolism and nutrition disorders Malnutrition	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Musculoskeletal and connective tissue disorders Pathological fracture	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Nervous system disorders Cerebral haemorrhage	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Nervous system disorders Dysarthria	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Nervous system disorders Loss of consciousness	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Nervous system disorders Peripheral sensory neuropathy	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Renal and urinary disorders Acute kidney injury	1.6% 1/62 • 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.	1.6% 1/63 • 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.
Renal and urinary disorders Calculus urinary	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Renal and urinary disorders Haematuria	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Renal and urinary disorders Nephrolithiasis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Renal and urinary disorders Urinary retention	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.6% 1/62 • 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.	0.00% 0/63 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Skin and subcutaneous tissue disorders Neutrophilic dermatosis	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/62 • 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.	1.6% 1/63 • 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.
Vascular disorders Peripheral artery stenosis	1.6% 1/62 • 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.	0.00% 0/63 • 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.

Other adverse events

Measure	MBG453 + Hypomethylating Agents (HMA) n=62 participants at risk Participants were taking MBG453 plus hypomethylating agents	Placebo + Hypomethylating Agents (HMA) n=63 participants at risk Participants were taking placebo plus hypomethylating agents
Blood and lymphatic system disorders Anaemia	35.5% 22/62 • 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.	50.8% 32/63 • 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.
Blood and lymphatic system disorders Febrile neutropenia	17.7% 11/62 • 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.	14.3% 9/63 • 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.
Blood and lymphatic system disorders Neutropenia	40.3% 25/62 • 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.	31.7% 20/63 • 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.
Blood and lymphatic system disorders Thrombocytopenia	32.3% 20/62 • 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.	20.6% 13/63 • 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.
Cardiac disorders Atrial fibrillation	8.1% 5/62 • 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.	3.2% 2/63 • 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.
Cardiac disorders Sinus tachycardia	0.00% 0/62 • 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.	6.3% 4/63 • 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.
Eye disorders Conjunctival haemorrhage	1.6% 1/62 • 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.	7.9% 5/63 • 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.
Gastrointestinal disorders Abdominal distension	6.5% 4/62 • 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.	3.2% 2/63 • 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.
Gastrointestinal disorders Abdominal pain	8.1% 5/62 • 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.	7.9% 5/63 • 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.
Gastrointestinal disorders Constipation	46.8% 29/62 • 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.	41.3% 26/63 • 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.
Gastrointestinal disorders Diarrhoea	43.5% 27/62 • 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.	23.8% 15/63 • 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.
Gastrointestinal disorders Haemorrhoids	9.7% 6/62 • 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.	9.5% 6/63 • 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.
Gastrointestinal disorders Nausea	24.2% 15/62 • 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.	30.2% 19/63 • 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.
Gastrointestinal disorders Stomatitis	6.5% 4/62 • 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.	14.3% 9/63 • 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.
Gastrointestinal disorders Toothache	6.5% 4/62 • 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.	3.2% 2/63 • 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.
Gastrointestinal disorders Vomiting	11.3% 7/62 • 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.	9.5% 6/63 • 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.
General disorders and administration site conditions Asthenia	17.7% 11/62 • 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.	11.1% 7/63 • 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.
General disorders and administration site conditions Chest pain	3.2% 2/62 • 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.	6.3% 4/63 • 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.
General disorders and administration site conditions Fatigue	22.6% 14/62 • 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.	12.7% 8/63 • 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.
General disorders and administration site conditions Injection site erythema	3.2% 2/62 • 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.	6.3% 4/63 • 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.
General disorders and administration site conditions Injection site reaction	6.5% 4/62 • 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.	15.9% 10/63 • 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.
General disorders and administration site conditions Oedema	4.8% 3/62 • 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.	7.9% 5/63 • 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.
General disorders and administration site conditions Oedema peripheral	12.9% 8/62 • 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.	11.1% 7/63 • 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.
General disorders and administration site conditions Pain	4.8% 3/62 • 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.	6.3% 4/63 • 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.
General disorders and administration site conditions Pyrexia	27.4% 17/62 • 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.	20.6% 13/63 • 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.
Infections and infestations COVID-19	14.5% 9/62 • 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.	6.3% 4/63 • 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.
Infections and infestations Cellulitis	4.8% 3/62 • 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.	6.3% 4/63 • 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.
Infections and infestations Nasopharyngitis	0.00% 0/62 • 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.	7.9% 5/63 • 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.
Infections and infestations Oral herpes	4.8% 3/62 • 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.	9.5% 6/63 • 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.
Infections and infestations Pneumonia	3.2% 2/62 • 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.	11.1% 7/63 • 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.
Infections and infestations Respiratory tract infection	8.1% 5/62 • 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.	0.00% 0/63 • 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.
Infections and infestations Urinary tract infection	14.5% 9/62 • 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.	4.8% 3/63 • 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.
Injury, poisoning and procedural complications Contusion	9.7% 6/62 • 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.	0.00% 0/63 • 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.
Injury, poisoning and procedural complications Procedural pain	6.5% 4/62 • 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.	0.00% 0/63 • 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.
Injury, poisoning and procedural complications Transfusion reaction	3.2% 2/62 • 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.	7.9% 5/63 • 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.
Investigations Alanine aminotransferase increased	6.5% 4/62 • 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.	19.0% 12/63 • 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.
Investigations Aspartate aminotransferase increased	9.7% 6/62 • 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.	14.3% 9/63 • 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.
Investigations Blood alkaline phosphatase increased	6.5% 4/62 • 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.	4.8% 3/63 • 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.
Investigations Blood bilirubin increased	1.6% 1/62 • 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.	7.9% 5/63 • 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.
Investigations Blood creatinine increased	3.2% 2/62 • 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.	7.9% 5/63 • 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.
Investigations Blood lactate dehydrogenase increased	4.8% 3/62 • 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.	7.9% 5/63 • 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.
Investigations Gamma-glutamyltransferase increased	3.2% 2/62 • 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.	11.1% 7/63 • 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.
Investigations Lymphocyte count decreased	4.8% 3/62 • 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.	7.9% 5/63 • 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.
Investigations Neutrophil count decreased	22.6% 14/62 • 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.	36.5% 23/63 • 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.
Investigations Platelet count decreased	19.4% 12/62 • 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.	30.2% 19/63 • 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.
Investigations SARS-CoV-2 test negative	8.1% 5/62 • 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.	11.1% 7/63 • 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.
Investigations Weight decreased	16.1% 10/62 • 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.	12.7% 8/63 • 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.
Investigations White blood cell count decreased	21.0% 13/62 • 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.	27.0% 17/63 • 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.
Metabolism and nutrition disorders Decreased appetite	21.0% 13/62 • 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.	9.5% 6/63 • 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.
Metabolism and nutrition disorders Hyperglycaemia	6.5% 4/62 • 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.	14.3% 9/63 • 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.
Metabolism and nutrition disorders Hyperkalaemia	3.2% 2/62 • 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.	6.3% 4/63 • 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.
Metabolism and nutrition disorders Hypernatraemia	3.2% 2/62 • 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.	6.3% 4/63 • 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.
Metabolism and nutrition disorders Hyperuricaemia	6.5% 4/62 • 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.	3.2% 2/63 • 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.
Metabolism and nutrition disorders Hypoalbuminaemia	9.7% 6/62 • 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.	7.9% 5/63 • 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.
Metabolism and nutrition disorders Hypocalcaemia	1.6% 1/62 • 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.	6.3% 4/63 • 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.
Metabolism and nutrition disorders Hypokalaemia	19.4% 12/62 • 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.	20.6% 13/63 • 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.
Metabolism and nutrition disorders Hypomagnesaemia	1.6% 1/62 • 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.	6.3% 4/63 • 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.
Metabolism and nutrition disorders Hyponatraemia	6.5% 4/62 • 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.	12.7% 8/63 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	12.9% 8/62 • 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.	12.7% 8/63 • 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.
Musculoskeletal and connective tissue disorders Back pain	19.4% 12/62 • 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.	11.1% 7/63 • 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.
Musculoskeletal and connective tissue disorders Myalgia	9.7% 6/62 • 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.	1.6% 1/63 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	17.7% 11/62 • 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.	9.5% 6/63 • 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.
Nervous system disorders Dizziness	12.9% 8/62 • 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.	7.9% 5/63 • 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.
Nervous system disorders Headache	12.9% 8/62 • 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.	11.1% 7/63 • 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.
Nervous system disorders Paraesthesia	6.5% 4/62 • 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.	0.00% 0/63 • 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.
Psychiatric disorders Insomnia	14.5% 9/62 • 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.	14.3% 9/63 • 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.
Renal and urinary disorders Acute kidney injury	8.1% 5/62 • 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.	4.8% 3/63 • 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.
Renal and urinary disorders Dysuria	6.5% 4/62 • 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.	4.8% 3/63 • 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.
Renal and urinary disorders Haematuria	6.5% 4/62 • 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.	4.8% 3/63 • 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.
Respiratory, thoracic and mediastinal disorders Cough	12.9% 8/62 • 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.	17.5% 11/63 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.7% 11/62 • 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.	19.0% 12/63 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.9% 8/62 • 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.	9.5% 6/63 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 5/62 • 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.	4.8% 3/63 • 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.
Skin and subcutaneous tissue disorders Erythema	9.7% 6/62 • 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.	3.2% 2/63 • 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.
Skin and subcutaneous tissue disorders Night sweats	9.7% 6/62 • 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.	3.2% 2/63 • 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.
Skin and subcutaneous tissue disorders Pruritus	17.7% 11/62 • 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.	11.1% 7/63 • 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.
Skin and subcutaneous tissue disorders Purpura	3.2% 2/62 • 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.	6.3% 4/63 • 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.
Skin and subcutaneous tissue disorders Rash	19.4% 12/62 • 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.	12.7% 8/63 • 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.
Vascular disorders Haematoma	6.5% 4/62 • 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.	4.8% 3/63 • 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.
Vascular disorders Hypertension	11.3% 7/62 • 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.	11.1% 7/63 • 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.
Vascular disorders Hypotension	4.8% 3/62 • 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.	9.5% 6/63 • 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.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER