Trial Outcomes & Findings for Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML (NCT NCT03306264)

NCT ID: NCT03306264

Last Updated: 2024-08-27

Results Overview

Total 5-day ASTX727 AUC0-24 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-24 (first ASTX727 dose) was added to (Day 2 AUC0-24+ Day 5 AUC0-24) × 2. Decitabine 5-day AUC0-24 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-24+ Day 5 AUC0-24) / 2 was multiplied by 5. If AUC0-24 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-24 on Day 5; the converse was also true.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

227 participants

Primary outcome timeframe

ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days)

Results posted on

2024-08-27

Participant Flow

A total of 227 participants took part in the study from 15 February 2018 to 25 May 2023. 138 participants with a diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) took part from the United States and Canada. 89 participants with a diagnosis of acute myeloid leukemia (AML) took part from Austria, Canada, Czech Republic, France, Germany, Hungary, Italy, Spain, and United Kingdom.

A total of 138 participants with a diagnosis of MDS or CMML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner. A total of 89 participants with a diagnosis of AML were enrolled and randomized in a 1:1 ratio to receive ASTX727 or decitabine in a crossover manner.

Participant milestones

Participant milestones
Measure
MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Overall Study
STARTED
69
69
44
45
Overall Study
Safety Analysis Set
66
67
43
44
Overall Study
COMPLETED
0
0
0
0
Overall Study
NOT COMPLETED
69
69
44
45

Reasons for withdrawal

Reasons for withdrawal
Measure
MDS or CMML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
MDS or CMML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: Sequence A: First ASTX727, Then IV Decitabine, Then ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Sequence B: First IV Decitabine, Then ASTX727, Then ASTX727
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days) followed by ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 2. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Overall Study
Death
33
25
34
34
Overall Study
Complete Consent Withdrawal
4
4
1
8
Overall Study
Lost to Follow-up
1
0
1
0
Overall Study
Rollover to ASTX727-06
10
18
4
2
Overall Study
Study Centre Terminated by Sponsor
21
22
4
1

Baseline Characteristics

Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MDS or CMML: ASTX727 or IV Decitabine
n=133 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: ASTX727 or IV Decitabine
n=87 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Total
n=220 Participants
Total of all reporting groups
Age, Customized
18 to 64 years
36 Participants
n=5 Participants
3 Participants
n=7 Participants
39 Participants
n=5 Participants
Age, Customized
65 to 84 years
93 Participants
n=5 Participants
75 Participants
n=7 Participants
168 Participants
n=5 Participants
Age, Customized
≥85 years
4 Participants
n=5 Participants
9 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Female
46 Participants
n=5 Participants
34 Participants
n=7 Participants
80 Participants
n=5 Participants
Sex: Female, Male
Male
87 Participants
n=5 Participants
53 Participants
n=7 Participants
140 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=5 Participants
0 Participants
n=7 Participants
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
125 Participants
n=5 Participants
0 Participants
n=7 Participants
125 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
87 Participants
n=7 Participants
89 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
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 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
4 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
White
121 Participants
n=5 Participants
0 Participants
n=7 Participants
121 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
5 Participants
n=5 Participants
87 Participants
n=7 Participants
92 Participants
n=5 Participants

PRIMARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Primary Endpoint Pharmacokinetics (PK) Analysis Set included participants who received full dose of ASTX727 within 3 hours of the intended dosing time, and no vomiting within 6 hours of dosing, and had at least 2 days of evaluable decitabine (AUC0-24) measurements in the ASTX727 cycle, i.e, Day 1 and either Day 2 or Day 5 and received the full IV decitabine dose as a 1-hour infusion.

Total 5-day ASTX727 AUC0-24 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-24 (first ASTX727 dose) was added to (Day 2 AUC0-24+ Day 5 AUC0-24) × 2. Decitabine 5-day AUC0-24 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-24+ Day 5 AUC0-24) / 2 was multiplied by 5. If AUC0-24 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-24 on Day 5; the converse was also true.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=123 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=123 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=69 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=69 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Total 5-day Area Under the Curve From 0 to 24 Hours (AUC0-24) After Treatment With ASTX727 And IV Decitabine
864.34 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 40.0
855.96 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 50.6
910.1 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52.4
900.5 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52.0

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years)

Population: The Safety Analysis Set included all participants who received any amount of study treatment.

An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=132 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=130 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS/CMML: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
127 Participants
130 Participants

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years)

Population: The Safety Analysis Set included all participants who received any amount of study treatment.

An AE is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=78 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=80 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Number of Participants With Treatment-emergent Adverse Events (AEs)
71 Participants
80 Participants

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment (up to approximately 2.7 years)

Population: The Safety Analysis Set included all participants who received any amount of study treatment.

TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=132 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=130 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS/CMML: Number of Participants With Grade 3 or Higher TEAEs
89 Participants
121 Participants

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment (up to approximately 2.4 years)

Population: The Safety Analysis Set included all participants who received any amount of study treatment.

TEAEs were defined as events that first occurred or worsened on or after the date of the first dose of study treatment until 30 days after the last dose of study treatment or until the start of a post-treatment alternative anti-cancer treatment, whichever occurred first. Severity of AEs were graded using CTCAE version 4.03. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=78 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=80 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Number of Participants With Grade 3 or Higher TEAEs
43 Participants
73 Participants

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1 and 2 (as Baseline), and Days 8, 15 and 22 of Cycles 1 and 2 (each cycle= 28 days)

Population: Pharmacodynamic (PD) LINE-1 Analysis Set included participants who received any amount of study treatment and have LINE-1 methylation data at baseline (Day 1) of Cycle 1 or 2 and on either Day 8 or Day 15 of the respective cycle. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those participants who were evaluable for this outcome measure at specified time point.

Summarized data for Cycle 1 and Cycle 2 was reported.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=63 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=63 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=39 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=34 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Maximum Percentage of Long Interspersed Nucleotide Elements (LINE)-1 Demethylation
Cycle 2
11.968 percentage of demethylation
Interval 10.503 to 13.434
11.151 percentage of demethylation
Interval 9.685 to 12.616
8.153 percentage of demethylation
Interval 6.226 to 10.079
8.037 percentage of demethylation
Interval 6.258 to 9.816
Maximum Percentage of Long Interspersed Nucleotide Elements (LINE)-1 Demethylation
Cycle 1
14.019 percentage of demethylation
Interval 12.528 to 15.51
13.289 percentage of demethylation
Interval 11.798 to 14.78
8.243 percentage of demethylation
Interval 6.34 to 10.147
9.357 percentage of demethylation
Interval 7.288 to 11.426

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants who may not have been included in the Primary Endpoint PK Analysis Set and who received any amount of study treatment, complied with the protocol sufficiently to ensure PK samples were collected as intended and provided sufficient samples to measure available plasma concentrations for decitabine. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

Total 5-day ASTX727 AUC0-inf exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-inf (first ASTX727 dose) was added to (Day 2 AUC0-inf+ Day 5 AUC0-inf) × 2. Decitabine 5-day AUC0-inf exposures after IV decitabine were calculated as follows: (Day 1 AUC0-inf+ Day 5 AUC0-inf) / 2 was multiplied by 5. If AUC0-inf on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-inf on Day 5; the converse was also true.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=123 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=123 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=69 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=69 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Total 5-day Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine
866.15 h*ng/mL
Geometric Coefficient of Variation 39.9
849.63 h*ng/mL
Geometric Coefficient of Variation 50.4
912.3 h*ng/mL
Geometric Coefficient of Variation 52.3
902.1 h*ng/mL
Geometric Coefficient of Variation 51.8

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants who may not have been included in the Primary Endpoint PK Analysis Set and received any amount of study treatment, complied with the protocol sufficiently to ensure PK samples were collected as intended and provided sufficient samples to measure available plasma concentrations for decitabine. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

Total 5-day ASTX727 AUC0-last exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-last (first ASTX727 dose) was added to (Day 2 AUC0-last + Day 5 AUC0-last) × 2. Decitabine 5-day AUC0-last exposures after IV decitabine were calculated as follows: (Day 1 AUC0-last + Day 5 AUC0-last) / 2 was multiplied by 5. If AUC0-last on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-last on Day 5; the converse was also true.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=124 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=124 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=70 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=70 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Total 5-day Area Under the Curve From 0 to Last Quantifiable Concentration (AUC0-last) After Treatment With ASTX727 And IV Decitabine
853.02 h*ng/mL
Geometric Coefficient of Variation 40.7
837.38 h*ng/mL
Geometric Coefficient of Variation 50.7
902.7 h*ng/mL
Geometric Coefficient of Variation 53.0
881.8 h*ng/mL
Geometric Coefficient of Variation 52.5

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 to 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants who may not have been included in the Primary Endpoint PK Analysis Set and received any amount of study treatment, complied with the protocol sufficiently to ensure PK samples were collected as intended and provided sufficient samples to measure available plasma concentrations for decitabine. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

Total 5-day ASTX727 AUC0-8 exposures were calculated using PK data from 3 days of serial PK sampling, Day 1 AUC0-8 (first ASTX727 dose) was added to (Day 2 AUC0-8 + Day 5 AUC0-8) × 2. Decitabine 5-day AUC0-8 exposures after IV decitabine were calculated as follows: (Day 1 AUC0-8 + Day 5 AUC0-8) / 2 was multiplied by 5. If AUC0-8 on Day 2 (for ASTX727) or Day 1 (IV decitabine) was not available, it was replaced by AUC0-8 on Day 5; the converse was also true.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=124 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=124 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=70 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=70 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Total 5-day Area Under the Curve From 0 to 8 Hours (AUC0-8) After Treatment With ASTX727 And IV Decitabine
856.63 h*ng/mL
Geometric Coefficient of Variation 40.6
839.37 h*ng/mL
Geometric Coefficient of Variation 50.4
910.1 h*ng/mL
Geometric Coefficient of Variation 52.0
883.8 h*ng/mL
Geometric Coefficient of Variation 52.1

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

AUC0-inf was calculated using the formula AUClast + (Clast / λZ), where Clast is the last quantifiable concentration and λZ is the elimination rate constant. AUC0-inf will be calculated using the linear up-log down method. Summarized data has been reported for cycle 1 and 2.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=119 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=127 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=70 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=78 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine
Day 1
174 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 40.8
102 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 54.8
175 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 54.9
118 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 54.4
Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine
Day 2
186 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 55.3
193 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 59.6
Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine
Day 5
170 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 41.7
178 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 52.7
181 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 58.1
187 nanograms*hours per millilitres(ng*h/mL)
Geometric Coefficient of Variation 57.1

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

Summarized data of Cmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Cmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=122 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=128 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=72 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=79 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 5
169 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65.9
191 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.4
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 1
184 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48.1
83.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 66.1
187 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64.7
85.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.6
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 2
145 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.7
139 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.5
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 5
180 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49.2
140 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.8
192 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.4
139 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.7
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 1
321 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.8
313 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.7
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 2
349 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49.1
343 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43.4
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 5
371 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51.8
350 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42.7
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 1
150 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65.7
182 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60.0
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 2
155 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64.6
204 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59.2

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

Summarized data of Tmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Tmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=122 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=128 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=72 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=79 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 5
3.00 hours
Interval 1.5 to 6.12
3.98 hours
Interval 1.0 to 8.0
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 1
3.08 hours
Interval 1.5 to 7.97
4.00 hours
Interval 1.5 to 8.03
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 1
0.98 hours
Interval 0.23 to 1.27
1.00 hours
Interval 0.48 to 3.0
0.98 hours
Interval 0.25 to 2.0
1.00 hours
Interval 0.25 to 2.02
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 2
1.00 hours
Interval 0.47 to 2.0
1.00 hours
Interval 0.25 to 3.0
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 5
0.97 hours
Interval 0.25 to 1.62
1.00 hours
Interval 0.25 to 3.0
0.98 hours
Interval 0.0 to 1.17
1.00 hours
Interval 0.47 to 3.0
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 1
3.00 hours
Interval 1.5 to 7.97
3.98 hours
Interval 1.47 to 8.0
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 2
3.01 hours
Interval 0.52 to 7.88
4.00 hours
Interval 1.0 to 7.88
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 2
3.03 hours
Interval 0.52 to 7.88
4.00 hours
Interval 1.5 to 7.88
Time to Reach Maximum Plasma Concentration (Tmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 5
3.08 hours
Interval 1.0 to 8.05
4.00 hours
Interval 1.53 to 8.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

Oral CL/F for oral decitabine was measured only on Day 1 and oral CL/F for oral cedazuridine was measured on Days 1, 2 and 5. Summarized data of Oral CL/F for oral decitabine on Day 1 for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of oral CL/F for oral cedazuridine on Day 1,2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=127 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=78 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Apparent Oral Clearance (CL/F) of Oral Decitabine and Cedazuridine
Cedazuridine: Day 2
25.6 Litres per hour (L/h)
Geometric Coefficient of Variation 159
27.4 Litres per hour (L/h)
Geometric Coefficient of Variation 45.4
Apparent Oral Clearance (CL/F) of Oral Decitabine and Cedazuridine
Decitabine: Day 1
342 Litres per hour (L/h)
Geometric Coefficient of Variation 54.8
297 Litres per hour (L/h)
Geometric Coefficient of Variation 54.4
Apparent Oral Clearance (CL/F) of Oral Decitabine and Cedazuridine
Cedazuridine: Day 1
30.6 Litres per hour (L/h)
Geometric Coefficient of Variation 46.4
28.6 Litres per hour (L/h)
Geometric Coefficient of Variation 55.5
Apparent Oral Clearance (CL/F) of Oral Decitabine and Cedazuridine
Cedazuridine: Day 5
16.8 Litres per hour (L/h)
Geometric Coefficient of Variation 15.9
86.8 Litres per hour (L/h)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as data for only one participant was available for analysis.

SECONDARY outcome

Timeframe: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

Summarized data of t1/2 on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of t1/2 on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=119 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=127 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=70 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=78 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 1
0.967 hours
Geometric Coefficient of Variation 46.8
1.18 hours
Geometric Coefficient of Variation 22.8
1.16 hours
Geometric Coefficient of Variation 56.7
1.07 hours
Geometric Coefficient of Variation 31.6
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 5
2.59 hours
Geometric Coefficient of Variation 5.43
2.41 hours
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as data for only one participant was available for analysis.
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 1
5.50 hours
Geometric Coefficient of Variation 21.8
6.22 hours
Geometric Coefficient of Variation 17.4
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 2
1.38 hours
Geometric Coefficient of Variation 24.7
1.36 hours
Geometric Coefficient of Variation 35.0
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Decitabine: Day 5
1.14 hours
Geometric Coefficient of Variation 44.9
1.47 hours
Geometric Coefficient of Variation 26.9
1.18 hours
Geometric Coefficient of Variation 49.0
1.45 hours
Geometric Coefficient of Variation 34.0
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 1
6.33 hours
Geometric Coefficient of Variation 18.1
6.68 hours
Geometric Coefficient of Variation 18.5
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine: Day 2
6.70 hours
Geometric Coefficient of Variation 18.9
7.05 hours
Geometric Coefficient of Variation 17.6
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 2
5.90 hours
Geometric Coefficient of Variation 23.2
6.15 hours
Geometric Coefficient of Variation 22.8
Apparent Elimination Half Life (t1/2) of Decitabine, Cedazuridine, and Cedazuridine-epimer
Cedazuridine-epimer: Day 5
2.58 hours
Geometric Coefficient of Variation 5.16
2.57 hours
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as data for only one participant was available for analysis.

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2 (each cycle= 28 days)

Population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

Summarized data of Vz/F on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=127 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=78 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
Decitabine: Day 5
417 Litres
Geometric Coefficient of Variation 54.3
373 Litres
Geometric Coefficient of Variation 68.9
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
Cedazuridine: Day 1
280 Litres
Geometric Coefficient of Variation 50.9
272 Litres
Geometric Coefficient of Variation 59.9
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
Decitabine: Day 1
585 Litres
Geometric Coefficient of Variation 55.0
434 Litres
Geometric Coefficient of Variation 60.4
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
Decitabine: Day 2
369 Litres
Geometric Coefficient of Variation 59.0
337 Litres
Geometric Coefficient of Variation 67.6
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
Cedazuridine: Day 2
296 Litres
Geometric Coefficient of Variation 51.3
278 Litres
Geometric Coefficient of Variation 49.8
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
Cedazuridine: Day 5
62.8 Litres
Geometric Coefficient of Variation 10.4
302 Litres
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated as data for only one participant was available for analysis.

SECONDARY outcome

Timeframe: Up to approximately 2.7 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment.

CR: normal peripheral, persistent granulocyte count ≥1.0x10\^9/liter(L), platelet ≥100x10\^9/L, Hemoglobin (Hgb) ≥11g/dL, normal bone marrow with persistent marrow blasts ≤5%. mCR: reduction of bone marrow blasts to≤5%, decrease by 50% or more with/without normalization of peripheral counts.PR: normal peripheral counts, granulocyte count ≥1.0x10\^9/L, platelet count ≥100x10\^9/L, Hgb ≥11 g/dL, normal bone marrow, marrow blasts \>5%, reduced by 50% or more for at least 4 weeks. HI: HI-E: Hb increase ≥1.5 g/dL in absence of RBC transfusions. HI-P: Absolute increase of platelet count from \<20 to \>20X10\^9/L by at least 100%,if more than 20x10\^9/L, by absolute increase of at least 30x10\^9/L in absence of platelet transfusions. HI-N: granulocyte increase ≥100%, by an absolute increase ≥0.5x10\^9/L for at least 8 weeks. Percentage of participants with CR, mCR, PR, and HI based on IWG 2003 MDS response criteria are reported. Response has been reported based on participants with MDS or CMML.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=61 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=56 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
n=5 Participants
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
n=11 Participants
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
HI: Neutrophil Response (HI-N)
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
9.1 percentage of participants
Interval 0.2 to 41.3
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
Complete Response (CR)
26.2 percentage of participants
Interval 15.8 to 39.1
19.6 percentage of participants
Interval 10.2 to 32.4
0 percentage of participants
Interval 0.0 to 0.0
18.2 percentage of participants
Interval 2.3 to 51.8
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
Marrow Complete Response (mCR)
29.5 percentage of participants
Interval 18.5 to 42.6
30.4 percentage of participants
Interval 18.8 to 44.1
40.0 percentage of participants
Interval 5.3 to 85.3
54.5 percentage of participants
Interval 23.4 to 83.3
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
Partial Response (PR)
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
HI: Erythroid Response (HI-E)
0 percentage of participants
Interval 0.0 to 0.0
1.8 percentage of participants
Interval 0.0 to 9.6
20.0 percentage of participants
Interval 0.5 to 71.6
0 percentage of participants
Interval 0.0 to 0.0
MDS/CMML: Percentage of Participants With Complete Response (CR), Marrow CR (mCR), Partial Response (PR), Hematologic Improvement (HI) Based on International Working Group (IWG) 2006 Myelodysplastic Syndromes (MDS) Response Criteria
HI: Platelet Response (HI-P)
3.3 percentage of participants
Interval 0.4 to 11.3
8.9 percentage of participants
Interval 3.0 to 19.6
0 percentage of participants
Interval 0.0 to 0.0
0 percentage of participants
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment.

CR was defined as absolute neutrophil content (ANC) ≥1000/ microliter (μL), platelets ≥100,000/μL, independence from red blood cell (RBC) and platelet transfusions over the past week, no leukemic blasts and \<5% leukemic blasts. CRp was defined as CR criteria except platelets \<100,000/μL.and platelet transfusion over the past week. CRi was defined as CR criteria except ANC \<1000/μL or platelets \<100,000/μL. Percentage of participants with CR, CRi, CRp, and CR Plus CRp based on IWG 2003 AML response criteria are reported.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=43 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=44 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria
Complete Response (CR)
14.0 percentage of participants
Interval 5.3 to 27.9
29.5 percentage of participants
Interval 16.8 to 45.2
AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria
CR with Incomplete Platelet Recovery (CRp)
4.7 percentage of participants
Interval 0.6 to 15.8
0 percentage of participants
Interval 0.0 to 8.0
AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria
CR with Incomplete Blood Count Recovery (CRi)
11.6 percentage of participants
Interval 3.9 to 25.1
0 percentage of participants
Interval 0.0 to 8.0
AML: Percentage of Participants With CR, CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Recovery (CRp), and CR Plus CRp Based on IWG 2003 AML Response Criteria
CR Plus CRp
18.6 percentage of participants
Interval 8.4 to 33.4
29.5 percentage of participants
Interval 16.8 to 45.2

SECONDARY outcome

Timeframe: Day 1 of Cycle 3 up to approximately 2.4 years (each cycle= 28 days)

Population: Efficacy Analysis Set included all participants who received any amount of study treatment.

CRh was defined as \<5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets \>50,000/μL and ANC \>500/μL), independence from RBC and platelet transfusions within 7 days of bone marrow evaluation, and peripheral blast ≤1%. Percentage of participants with CRh based on IWG 2003 AML response criteria are reported.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=43 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
n=44 Participants
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Percentage of Participants With CR With Partial Hematologic Recovery (CRh) Based on IWG 2003 AML Response Criteria
4.7 percentage of participants
Interval 0.6 to 15.8
0 percentage of participants
Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment.

Time to first response was defined as time in months from the date of first treatment to the first date when any response is achieved. Time to best response was defined in months from the date of first treatment to the first date when a subject's best response, in the order of CR, CRi (or CRp or CRh), or PR, was achieved. Time to CR was defined in months from the date of first treatment to the first date when CR is achieved. CR:ANC ≥1000/ microliter (μL),platelets ≥100,000/μL,independence from RBC and platelet transfusions over the past week, no leukemic blasts, and \<5% leukemic blasts.CRp: CR criteria except ANC ≥1000/μL, platelets \< 100,000/μL.and platelet transfusion over the past week. CRi:CR criteria except ANC \<1000/μL or platelets \<100,000/μL.CRh: \<5% of blasts in the bone marrow,platelets \>50,000/μL and ANC \>500/μL, independence from RBC and platelet transfusions within 7 days and peripheral blast ≤1%. PR: CR criteria except decrease of ≥50% in leukemic blasts.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=87 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Time to First Response, Best Response and Complete Response Based on IWG 2003 AML Response Criteria
Time to First Response
2.91 months
Interval 1.9 to 6.5
AML: Time to First Response, Best Response and Complete Response Based on IWG 2003 AML Response Criteria
Time to Best Response
3.45 months
Interval 1.9 to 7.5
AML: Time to First Response, Best Response and Complete Response Based on IWG 2003 AML Response Criteria
Time to Complete Response
3.02 months
Interval 1.9 to 7.5

SECONDARY outcome

Timeframe: Up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment.

Duration of CR was defined as the time interval from the first CR to time of relapse. Duration of combined CR and CRh was defined as the time interval from the first CR or CRh to time of relapse. Duration of CR and combined CR and CRh was presented using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=87 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria
Duration of Complete Response
6.9 months
Interval 3.4 to 11.5
AML: Duration of Complete Response and Combined CR and CRh Based on IWG 2003 AML Response Criteria
Duration of Combined CR and CRh
9.0 months
Interval 3.4 to 11.5

SECONDARY outcome

Timeframe: Up to approximately 2.7 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those subjects who were evaluable for this outcome measure in specified category.

Transfusion independence was defined as no transfusion for 56 consecutive days or more (84 and 112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI).

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=54 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
Platelet TI: ≥84 Days
33.3 percentage of participants
Interval 9.9 to 65.1
MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
RBC TI: ≥56 Days
51.9 percentage of participants
Interval 37.8 to 65.7
MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
RBC TI: ≥84 Days
40.7 percentage of participants
Interval 27.6 to 55.0
MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
RBC TI: ≥112 Days
33.3 percentage of participants
Interval 21.1 to 47.5
MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
Platelet TI: ≥56 Days
50.0 percentage of participants
Interval 21.1 to 78.9
MDS/CMML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
Platelet TI: ≥112 Days
33.3 percentage of participants
Interval 9.9 to 65.1

SECONDARY outcome

Timeframe: Up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure. 'Number analyzed' signifies those subjects who were evaluable for this outcome measure at specified category.

Transfusion independence was defined as no transfusion for 56 consecutive days or more (112 days) after the first dose of study treatment while maintaining hemoglobin ≥8 grams/deciliter (g/dL) (RBC TI) or maintaining platelets ≥20×109/L (platelet TI).

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=37 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
RBC TI ≥56 Days
37.8 percentage of participants
Interval 22.5 to 55.2
AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
RBC TI ≥112 Days
24.3 percentage of participants
Interval 11.8 to 41.2
AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
Platelet TI ≥56 Days
35.7 percentage of participants
Interval 12.8 to 64.9
AML: Percentage of Participants With Red Blood Cell (RBC) and Platelet Transfusion Independence (TI)
Platelet TI ≥112 Days
28.6 percentage of participants
Interval 8.4 to 58.1

SECONDARY outcome

Timeframe: From randomization up to approximately 2.7 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

LFS was defined as time from the date of randomization to the date when bone marrow or peripheral blood blasts reach ≥20%, or death from any cause. Participants who hadn't reached AML at the time of the analysis were censored at the date of the last follow-up. Leukemia-free survival was presented using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=62 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS/CMML: Leukemia-free Survival (LFS)
889.0 days
Interval 674.0 to
The upper limit of the 95% Confidence Interval (CI) was not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: From randomization up to approximately 2.7 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=58 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS/CMML: Overall Survival (OS)
966.0 days
Interval 809.0 to
The upper limit of the 95% CI was not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: From randomization up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

OS was defined as time from the date of randomization to the date of death from any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. Overall survival was presented using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=67 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Overall Survival (OS)
8.9 months
Interval 5.9 to 13.1

SECONDARY outcome

Timeframe: At Month 6, Year 1 and 2

Population: Efficacy Analysis Set included all participants who received any amount of study treatment.

One-year survival rate was defined as the survival rate at the end of the first year from the date of randomization. The survival rates at 6 months and at 2 years were calculated similarly.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=87 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Survival Rates at 6 Months, 1 Year, and 2 Years
Month 6
61 percentage of participants
Interval 50.0 to 71.0
AML: Survival Rates at 6 Months, 1 Year, and 2 Years
Year 1
44 percentage of participants
Interval 33.0 to 54.0
AML: Survival Rates at 6 Months, 1 Year, and 2 Years
Year 2
16 percentage of participants
Interval 8.0 to 26.0

SECONDARY outcome

Timeframe: From randomization up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

EFS was defined as time from the date of randomization to the date of treatment failure \[disease progression/relapse (due to confirmed reappearance of leukemic blasts in peripheral blood or ≥5% leukemic blasts in bone marrow (including relapse), discontinue treatment due to disease progression or treatment-related AE, or alternative anti-leukemia therapy except for HCT\] or death from any cause, whichever occurs first. Participants without documented treatment failure at the time of the analysis were censored at the date of the last follow-up. Event-free survival was presented using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=82 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Event-free Survival (EFS)
5.9 months
Interval 3.8 to 8.5

SECONDARY outcome

Timeframe: From randomization up to approximately 2.4 years

Population: Efficacy Analysis Set included all participants who received any amount of study treatment. 'Overall number of participants analyzed' signifies those who were evaluable for this outcome measure.

PFS was defined as time from the date of randomization to the date disease progression due to confirmed reappearance of leukemic blasts in peripheral blood or ≥5% leukemic blasts in bone marrow (including relapse) or death from any cause, whichever occurs first. Participants without documented disease progression/relapse or death at the time of the analysis were censored at the date of the last follow-up. Progression-free survival was presented using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure
MDS or CMML: IV Decitabine
n=78 Participants
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
MDS or CMML: ASTX727
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
AML: IV Decitabine
Participants with AML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle=28 days).
AML: ASTX727
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Progression-free Survival (PFS)
6.1 months
Interval 4.0 to 8.7

Adverse Events

MDS or CMML: IV Decitabine

Serious events: 24 serious events
Other events: 127 other events
Deaths: 2 deaths

MDS or CMML: ASTX727

Serious events: 81 serious events
Other events: 130 other events
Deaths: 56 deaths

MDS or CMML: Not Treated

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

AML: IV Decitabine

Serious events: 19 serious events
Other events: 70 other events
Deaths: 5 deaths

AML: ASTX727

Serious events: 65 serious events
Other events: 76 other events
Deaths: 61 deaths

AML: Not Treated

Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
MDS or CMML: IV Decitabine
n=132 participants at risk
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days).
MDS or CMML: ASTX727
n=130 participants at risk
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS or CMML: Not Treated
n=5 participants at risk
Participants with MDS or CMML were enrolled in the study but did not receive any study treatment.
AML: IV Decitabine
n=78 participants at risk
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2.
AML: ASTX727
n=80 participants at risk
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Not Treated
n=2 participants at risk
Participants with AML were enrolled in the study but did not receive any study treatment.
Blood and lymphatic system disorders
Febrile neutropenia
6.1%
8/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
25.4%
33/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
26.2%
21/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Thrombocytopenia
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.3%
3/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Anaemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Aplasia pure red cell
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Neutropenia
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Pancytopenia
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Haematotoxicity
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Lymphadenitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Myocardial infarction
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Acute coronary syndrome
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Acute myocardial infarction
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Cardiac Failure
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Cardiac Failure Congestive
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Tachycardia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Colitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Proctitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Diarrhoea
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Enteritis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Gingival bleeding
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Proctalgia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Constipation
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Gastritis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Gastrointestinal Perforation
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Intestinal Ischaemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Pancreatitis Chronic
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Pyrexia
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.3%
3/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Asthenia
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Oedema peripheral
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Multiple Organ Dysfunction Syndrome
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Fatigue
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
General Physical Health Deterioration
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Mucosal Inflammation
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Polyserositis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Sudden Death
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
50.0%
1/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Hepatobiliary disorders
Hyperbilirubinaemia
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Hepatobiliary disorders
Jaundice Cholestatic
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pneumonia
4.5%
6/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
13.1%
17/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.0%
16/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Sepsis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Cellulitis
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
5/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Diverticulitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.3%
3/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Influenza
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Upper respiratory tract infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Bacteraemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Bronchopulmonary aspergillosis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Clostridium difficile colitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Colonic abscess
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Device related infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Enterobacter infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Gastroenteritis Escherichia coli
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Gastroenteritis viral
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Oral candidiasis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Parainfluenzae virus infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Peritonsillitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pharyngitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pneumonia cytomegaloviral
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pseudomonal bacteraemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Septic shock
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Sinusitis fungal
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Urinary tract infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Vascular device infection
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
5/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Bronchitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Neutropenic Sepsis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Escherichia Bacteraemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pneumonia Fungal
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Urosepsis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Abdominal Abscess
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Anal Abscess
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Anorectal Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Cellulitis Staphylococcal
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Cholecystitis Infective
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Clostridium Colitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Corona Virus Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Enterococcal Bacteraemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Escherichia Urinary Tract Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Klebsiella Bacteraemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Liver Abscess
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pneumonia Necrotising
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pneumonia Viral
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Post Procedural Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Sinusitis Aspergillus
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Tuberculosis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Fall
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.3%
3/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Hip fracture
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Ankle Fracture
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Exposure To Communicable Disease
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Multiple Fractures
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Subdural Haematoma
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Influenza A virus test positive
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
C-Reactive Protein Increased
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Dehydration
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with unilineage dysplasia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Syncope
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.3%
3/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.5%
2/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Dizziness
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Transient ischaemic attack
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Migraine
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Cerebrovascular Accident
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Epilepsy
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Ischaemic Stroke
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Psychiatric disorders
Depression
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Psychiatric disorders
Suicide attempt
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Psychiatric disorders
Confusional State
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Renal and urinary disorders
Acute kidney injury
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Renal and urinary disorders
Renal Failure
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.5%
2/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Angioedema
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Embolism
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.3%
3/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Deep vein thrombosis
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Embolism arterial
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Haematoma
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Hypertension
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Hypotension
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.77%
1/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Extravasation Blood
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Phlebitis
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Social circumstances
Loss Of Personal Independence In Daily Activities
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.2%
1/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.

Other adverse events

Other adverse events
Measure
MDS or CMML: IV Decitabine
n=132 participants at risk
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days).
MDS or CMML: ASTX727
n=130 participants at risk
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
MDS or CMML: Not Treated
n=5 participants at risk
Participants with MDS or CMML were enrolled in the study but did not receive any study treatment.
AML: IV Decitabine
n=78 participants at risk
Participants with MDS or CMML received IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycles 1 or 2.
AML: ASTX727
n=80 participants at risk
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycles 1 or 2 (each cycle = 28 days). From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
AML: Not Treated
n=2 participants at risk
Participants with AML were enrolled in the study but did not receive any study treatment.
Psychiatric disorders
Insomnia
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
14.6%
19/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.2%
9/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Thrombocytopenia
39.4%
52/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
69.2%
90/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
38.5%
30/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
58.8%
47/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Neutropenia
34.1%
45/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
60.8%
79/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.3%
8/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
33.8%
27/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Anaemia
35.6%
47/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
55.4%
72/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
26.9%
21/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
51.2%
41/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Leukopenia
17.4%
23/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
28.5%
37/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.2%
9/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Lymphopenia
3.8%
5/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
8/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders
Febrile Neutropenia
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
8.8%
7/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Eye disorders
Conjunctival Haemorrhage
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Constipation
19.7%
26/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
49.2%
64/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.3%
8/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
18.8%
15/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Nausea
17.4%
23/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
48.5%
63/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
21.2%
17/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Diarrhoea
10.6%
14/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
41.5%
54/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
21.2%
17/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Vomiting
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.0%
26/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.5%
10/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Stomatitis
3.8%
5/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
17.7%
23/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Abdominal Pain
3.8%
5/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
15.4%
20/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Haemorrhoids
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.9%
9/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Toothache
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.9%
9/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Dyspepsia
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
8/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Fatigue
17.4%
23/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
52.3%
68/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.2%
9/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Oedema Peripheral
7.6%
10/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
27.7%
36/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.3%
8/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.0%
16/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Asthenia
4.5%
6/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
22.3%
29/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
6/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
25.0%
20/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Pyrexia
7.6%
10/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.8%
27/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
6/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
22.5%
18/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Chills
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
13/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Non-Cardiac Chest Pain
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.9%
9/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Pain
3.8%
5/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
8/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
General disorders
Peripheral Swelling
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Upper Respiratory Tract Infection
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.3%
16/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Urinary Tract Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.3%
16/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
8/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Cellulitis
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
8.5%
11/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Nasopharyngitis
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Pneumonia
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Corona Virus Infection
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
5/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Contusion
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
18.5%
24/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Fall
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.3%
16/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
8/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications
Procedural Pain
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Alanine Aminotransferase Increased
5.3%
7/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
15.4%
20/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Blood Creatinine Increased
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
13.1%
17/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Aspartate Aminotransferase Increased
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.8%
14/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
5/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Blood Alkaline Phosphatase Increased
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
8.5%
11/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Blood Bilirubin Increased
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
Weight Decreased
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Investigations
C-Reactive Protein Increased
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
8.8%
7/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Decreased Appetite
5.3%
7/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
33.1%
43/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.4%
5/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
15.0%
12/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hypokalaemia
5.3%
7/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.8%
27/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
18.8%
15/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hyperglycaemia
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.8%
14/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hypocalcaemia
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.8%
14/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hyponatraemia
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
9.2%
12/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hypoalbuminaemia
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.9%
9/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Hypomagnesaemia
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.9%
9/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders
Dehydration
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
4.5%
6/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
24.6%
32/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
8/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Back Pain
6.8%
9/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.0%
26/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.1%
4/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.2%
9/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Myalgia
5.3%
7/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
16.2%
21/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Pain In Extremity
3.8%
5/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
13.8%
18/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Muscle Spasms
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
13/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Bone Pain
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
8.5%
11/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
8/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders
Neck Pain
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
8/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Headache
14.4%
19/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
38.5%
50/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Nervous system disorders
Dizziness
9.8%
13/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
32.3%
42/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
8/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Psychiatric disorders
Anxiety
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Psychiatric disorders
Depression
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Renal and urinary disorders
Haematuria
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Renal and urinary disorders
Pollakiuria
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
5/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
9.1%
12/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
34.6%
45/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Cough
7.6%
10/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
30.8%
40/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.2%
9/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
10.6%
14/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
20.0%
26/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
4.5%
6/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.3%
16/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
8.8%
7/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.5%
15/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
2.3%
3/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.5%
6/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
13.1%
17/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Rash
3.0%
4/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.3%
16/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Alopecia
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
13/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Petechiae
3.8%
5/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
9.2%
12/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Pruritus
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.9%
9/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Skin Lesion
0.76%
1/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
6.2%
8/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders
Night Sweats
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.4%
7/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Hypotension
4.5%
6/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
12.3%
16/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Hypertension
1.5%
2/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
7.7%
10/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
10.0%
8/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Vascular disorders
Haematoma
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
3.8%
3/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
11.2%
9/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Cardiac disorders
Atrial Fibrillation
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Dry Mouth
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Gastrointestinal disorders
Tongue Ulceration
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
1.3%
1/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Infections and infestations
Oral Herpes
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
Psychiatric disorders
Confusional State
0.00%
0/132 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/130 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/5 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
2.6%
2/78 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
5.0%
4/80 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.
0.00%
0/2 • MDS or CMML: From randomization up to 2.7 years; AML: From randomization up to 2.4 years
All-cause mortality: Randomized Analysis Set included all randomized participants. Serious adverse events and non-serious adverse events: Safety Analysis Set included all participants who received any amount of study treatment.

Additional Information

Taiho Central

Taiho Oncology, Inc.

Phone: 609-250-7336

Results disclosure agreements

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