Trial Outcomes & Findings for A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy (NCT NCT04023526)

Last Updated: 2025-08-20

Results Overview

Complete remission based on European Leukemia Network (ELN) 2017 response criteria. Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

Up to 3 years and 5 months

Results posted on

2025-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Overall Study STARTED	51	52
Overall Study COMPLETED	46	42
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Overall Study Ongoing treatment at data cutoff	5	9
Overall Study Randomized but did not receive assigned treatment	0	1

Baseline Characteristics

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.	Total n=103 Participants Total of all reporting groups
Age, Continuous	74 years n=5 Participants	75 years n=7 Participants	74 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Turkey	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Italy	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment France	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Australia	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Switzerland	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Russia	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Spain	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years and 5 months

Population: Intention-to-treat (ITT)

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Percentage of Participants With Complete Remission (CR)	11.76 percentage of participants Interval 5.5 to 23.4	26.92 percentage of participants Interval 16.8 to 40.3

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: ITT

CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Percentage of Participants With CR With Partial Hematological Recovery (CRh)	9.8 percentage of participants Interval 4.3 to 21.0	7.7 percentage of participants Interval 3.0 to 18.2

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: ITT

CR plus CRh based on ELN 2017 response criteria. CR defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Percentage of Participants With CR Plus CRh	21.6 percentage of participants Interval 12.5 to 34.6	34.6 percentage of participants Interval 23.2 to 48.2

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: ITT

CRi based on ELN 2017 response criteria. Defined as meeting all CR criteria except for residual neutropenia (ANC \<1.0x10\^9/L) or thrombocytopenia (platelets \<100x10\^9/L)

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Percentage of Participants With CR With Incomplete Recovery (CRi)	7.8 percentage of participants Interval 3.1 to 18.15	5.8 percentage of participants Interval 2.0 to 15.6

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: ITT

ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria.

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Overall Response Rate (ORR)	29.4 percentage of participants Interval 18.7 to 43.0	40.4 percentage of participants Interval 28.2 to 53.9

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: ITT

CR without minimal residual disease (MRD) defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3 by flow cytometry).

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Percentage of Participants With CR Without MRD	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as less than (\<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: Responder population: Participants who achieved CR, CRh or CRi

Defined as time from randomization to achieving the first response of CR, CRh, or CRi.

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=15 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=21 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Time to First Response	2.8 Months Interval 2.6 to 3.5	3 Months Interval 2.8 to 3.9

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: Responder population: Participants who achieved CR, CRh or CRi

Defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause.

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=15 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=21 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Duration of First Response	5.6 Months Interval 0.7 to Upper limit of 95% CI is not estimable due to some participants still being in CR	13.6 Months Interval 6.3 to Upper limit of 95% CI is not estimable due to some participants still being in CR

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: ITT

Defined as a period of at least 56 consecutive days with no transfusion of RBC and/or platelets between first dose of study drug and the last dose of study drug +30 days.

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=51 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=52 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Red Blood Cell (RBC) and/or Platelets Transfusion Independence RBC and Platelets Transfusion Independence	27.5 percentage of participants Interval 15.9 to 41.7	36.5 percentage of participants Interval 23.6 to 51.0
Red Blood Cell (RBC) and/or Platelets Transfusion Independence RBC Transfusion Independence	29.4 percentage of participants Interval 17.5 to 43.8	42.3 percentage of participants Interval 28.7 to 56.8
Red Blood Cell (RBC) and/or Platelets Transfusion Independence Platelets Transfusion Independence	39.2 percentage of participants Interval 25.8 to 53.9	51.9 percentage of participants Interval 37.6 to 66.0

SECONDARY outcome

Timeframe: Cycle 1 Day 3

Population: All participants with available serum concentrations per intervention group.

Cmin is the minimum cusatuzumab serum concentration observed at Cycle 1 Day 3

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=30 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=27 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Cusatuzumab Minimum Serum Concentration (Cmin)	NA micrograms/milliliter Standard Deviation NA Level below the quantification limit	NA micrograms/milliliter Standard Deviation NA Level below the quantification limit

SECONDARY outcome

Timeframe: Cycle 1 Day 3

Population: All participants with available serum concentrations per intervention group

Cmax is the maximum cusatuzumab serum concentration observed at Cycle 1 Day 3.

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=27 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=25 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Maximum Serum Concentration (Cmax) of Cusatuzumab	224 micrograms/milliliter Standard Deviation 54.1	458 micrograms/milliliter Standard Deviation 89.7

SECONDARY outcome

Timeframe: Up to 3 years and 5 months

Population: Participants with evaluable samples.

Number of participants exhibiting anti-drug antibodies for cusatuzumab.

Outcome measures

Outcome measures
Measure	Cusatuzumab 10 mg/kg Plus Azacitidine n=47 Participants Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle.	Cusatuzumab 20 mg/kg Plus Azacitidine n=46 Participants Participants received azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Number of Participants With Anti-cusatuzumab Antibodies	7 Participants	2 Participants

Adverse Events

Cusatuzumab 10 mg/kg Plus Azacitdine

Serious events: 44 serious events

Other events: 51 other events

Deaths: 39 deaths

Cusatuzumab 20 mg/kg Plus Azacitidine

Serious events: 40 serious events

Other events: 50 other events

Deaths: 30 deaths

Serious adverse events

Other adverse events

Additional Information

Clay Smith, MD Chief Medical Officer

OncoVerity

Phone: 7204981136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	Cusatuzumab 10 mg/kg Plus Azacitdine n=51 participants at risk Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle. .	Cusatuzumab 20 mg/kg Plus Azacitidine n=51 participants at risk Participants will receive azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Infections and infestations Pneumonia	19.6% 10/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	17.6% 9/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations COVID-19 pneumonia	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	11.8% 6/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Sepsis	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Bronchopulmonary aspergillosis	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Septic Shock	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Soft tissue infection	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Urinary tract infection	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations COVID-19	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Diverticulitis	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Lower respiratory tract infection	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Pseudomonal sepsis	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Alpha haemolytic streptococcal infection	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Arthritis bacterial	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Device related sepsis	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Disseminated varicella zoster virus infection	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Endocarditis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Erysipelas	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Escherichia sepsis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Gastroenteritis	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Infection	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Influenza	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Injection site abscess	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Pneumonia pseudomonal	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Pseudomembranous colitis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Staphylococcal sepsis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Tooth infection	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Toxic shock syndrome	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Streptococcal bacteraemia	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Vascular device infection	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Febrile neutropenia	19.6% 10/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	7.8% 4/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Anaemia	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Lymphadenitis	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Thrombocytopenia	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Pyrexia	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders General physical health deterioration	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Multiple organ dysfunction syndrome	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Sudden death	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Asthenia	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Death	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.

Other adverse events
Measure	Cusatuzumab 10 mg/kg Plus Azacitdine n=51 participants at risk Participants received azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle. .	Cusatuzumab 20 mg/kg Plus Azacitidine n=51 participants at risk Participants will receive azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle.
Blood and lymphatic system disorders Thrombocytopenia	51.0% 26/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	58.8% 30/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Anaemia	47.1% 24/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	35.3% 18/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Neutropenia	39.2% 20/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	41.2% 21/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Leukopenia	25.5% 13/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	31.4% 16/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Febrile neutropenia	21.6% 11/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	17.6% 9/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Blood and lymphatic system disorders Lymphopenia	25.5% 13/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	13.7% 7/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Pneumonia	29.4% 15/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	25.5% 13/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations COVID-19 pneumonia	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	11.8% 6/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Urinary tract infection	9.8% 5/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Oral herpes	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Sepsis	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Upper respiratory tract infection	7.8% 4/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Diverticulitis	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Oral candidiasis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Infections and infestations Pharyngitis	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Constipation	37.3% 19/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	37.3% 19/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Nausea	33.3% 17/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	37.3% 19/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Diarrhoea	29.4% 15/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	27.5% 14/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Vomiting	17.6% 9/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	21.6% 11/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Abdominal pain	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Haemorrhoids	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	9.8% 5/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Abdominal pain upper	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Gastrointestinal disorders Stomatitis	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	2.0% 1/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Pyrexia	31.4% 16/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	29.4% 15/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Asthenia	15.7% 8/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	21.6% 11/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Oedema peripheral	15.7% 8/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	11.8% 6/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Chills	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	7.8% 4/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Fatigue	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders General physical health deterioration	3.9% 2/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Hyperthermia	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Non-cardiac chest pain	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
General disorders Sudden death	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	0.00% 0/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Hypokalaemia	27.5% 14/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	15.7% 8/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Decreased appetite	17.6% 9/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	19.6% 10/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Hypomagnesaemia	13.7% 7/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	9.8% 5/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Hypophosphataemia	9.8% 5/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	11.8% 6/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Hypoalbuminaemia	9.8% 5/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Metabolism and nutrition disorders Hyponatraemia	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	5.9% 3/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Respiratory, thoracic and mediastinal disorders Cough	11.8% 6/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.	15.7% 8/51 • From first dose of study treatment at study day 1 until 30 days after the last dose of study intervention or until the start of subsequent anti-AML therapy (up to approximately 3 years and 5 months) Treatment emergent events with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.