Trial Outcomes & Findings for Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1 (NCT NCT04874194)

Last Updated: 2025-11-03

Results Overview

The RP2D will be selected at the end of the Phase 1b portion based on safety data , in Arms A and B independently. Preliminary efficacy and PK data for each dose level may also be considered as appropriate.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2025-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ph 1 Arm A (AML) Dose 0 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Overall Study STARTED	3	2	9	10
Overall Study COMPLETED	3	2	9	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ph 2 Arm A (AML) Dose +1 n=10 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Total n=24 Participants Total of all reporting groups	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose 0 n=3 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Age, Categorical <=18 years	0 Participants n=7 Participants	—	0 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Region of Enrollment United States	10 participants n=7 Participants	—	24 participants n=9 Participants	—	3 participants n=3 Participants	2 participants n=15 Participants	9 participants n=18 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	—	15 Participants n=9 Participants	—	3 Participants n=3 Participants	2 Participants n=15 Participants	6 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	—	0 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	—	1 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	1 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	—	0 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	1 Participants n=7 Participants	—	3 Participants n=9 Participants	—	1 Participants n=3 Participants	0 Participants n=15 Participants	1 Participants n=18 Participants
Race (NIH/OMB) White	9 Participants n=7 Participants	—	20 Participants n=9 Participants	—	2 Participants n=3 Participants	2 Participants n=15 Participants	7 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	—	0 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	—	0 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=7 Participants	—	9 Participants n=9 Participants	—	0 Participants n=3 Participants	1 Participants n=15 Participants	5 Participants n=18 Participants
Age, Categorical >=65 years	7 Participants n=7 Participants	—	15 Participants n=9 Participants	—	3 Participants n=3 Participants	1 Participants n=15 Participants	4 Participants n=18 Participants
Age, Continuous	73 years n=7 Participants	—	72 years n=9 Participants	—	72 years n=3 Participants	70 years n=15 Participants	65 years n=18 Participants
Sex: Female, Male Female	6 Participants n=7 Participants	—	9 Participants n=9 Participants	—	0 Participants n=3 Participants	0 Participants n=15 Participants	3 Participants n=18 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Population: RP2D was only assessed in the phase 1 portion of the study. In the phase 1b portion of the MDS arm, 2 patients were treated at dose level 0 before the study was closed by the sponsor.

Outcome measures

Outcome measures
Measure	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose 0 n=14 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Recommended Phase 2 Dose (RP2D) of Omacetaxine in Combination With Venetoclax Omacetaxine (days 2-4)	—	—	—	1.25 mg/m2	—	—
Recommended Phase 2 Dose (RP2D) of Omacetaxine in Combination With Venetoclax Venetoclax (days 1-14)	—	—	—	400 mg/m2	—	—

PRIMARY outcome

Timeframe: At day 28, and 3 cycles.

Population: Of the 24 patients enrolled in the study, three were not evaluable for response. One participant in Ph 1 Arm A (AML) Dose 0 was not evaluable for response. Two participants in Ph 2 Arm A (AML) Dose +1 were not available for response.

Complete Remission for AML is defined as: Absolute neutrophil count \> 10\^3/UL, platelets . 10\^5/UL, red cell transfusion independence, absence of extramedullary disease, and bone marrow with \< 5% blasts. Complete Remission for MDS is defined as: Absolute neutrophil count \> 10\^3/UL, platelets . 10\^5/UL, hemoglobin \>11 g/dl, and bone marrow with \< 5% blasts. Peripheral dysplasia will be noted.

Outcome measures

Outcome measures
Measure	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 n=8 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Number of Participant to Achieve Complete Remission	—	0 Participants	—	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Two years, 8 months, 30 days

Population: Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor.

Time from date of treatment start until the date of failure or death from any cause.

Outcome measures

Outcome measures
Measure	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 n=10 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose 0 n=3 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Event-free Survival (EFS)	—	1.1 Months Interval 0.8 to 3.2	—	1.1 Months Interval 0.6 to 3.4	16.8 Months Interval 9.3 to 24.3	1.0 Months Interval 0.6 to 2.8

SECONDARY outcome

Timeframe: Up to Two years, 8 months, 30 days

Population: Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor. Survival will be presented by median survival, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%.

The Kaplan-Meier method will be used to estimate the probabilities. Log-rank tests will be used to compare among subgroups of patients in terms of OS.

Outcome measures

Outcome measures
Measure	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 n=10 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose 0 n=3 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Overall Survival (OS)	—	3.4 Months Interval 1.0 to 14.3	—	9.4 Months Interval 0.6 to 13.7	NA Months Insufficient number of participants with events	4.0 Months Interval 1.1 to 9.2

SECONDARY outcome

Timeframe: Up to Two years, 8 months, 30 days

Population: Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor.

Response date to loss of response or last follow up.

Outcome measures

Outcome measures
Measure	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 n=10 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 Participants Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Duration of Response	—	NA Month insufficient number of participants with events	—	NA Month insufficient number of participants with events	15.0 Month Interval 7.3 to 23.3	NA Month insufficient number of participants with events

Adverse Events

Ph 1 Arm A (AML) Dose 0

Serious events: 3 serious events

Other events: 1 other events

Deaths: 1 deaths

Ph 1 Arm B (MDS) Dose 0

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Ph 1 Arm A (AML) Dose +1

Serious events: 5 serious events

Other events: 5 other events

Deaths: 1 deaths

Ph 1 Arm B (MDS) Dose + 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ph 2 Arm A (AML) Dose +1

Serious events: 7 serious events

Other events: 4 other events

Deaths: 2 deaths

Ph 2 Arm B (MDS) Dose + 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ph 1 Arm A (AML) Dose 0 n=3 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 n=10 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Psychiatric disorders Confusion	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
General disorders Fatigue	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	50.0% 1/2 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	22.2% 2/9 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Gastrointestinal disorders Diverticulitis	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
General disorders Non-neutropenic fever	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
General disorders Failure to thrive	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Musculoskeletal and connective tissue disorders Weakness	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	50.0% 1/2 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	20.0% 2/10 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	100.0% 2/2 • Number of events 3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	30.0% 3/10 • Number of events 3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Infections and infestations Lung infection	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	50.0% 1/2 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Nervous system disorders Right middle cerebellar peduncle and medullary lesion - (Brain Lesions)	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Nervous system disorders Slurred speech	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Psychiatric disorders Altered mental status	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Renal and urinary disorders Renal Failure	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Respiratory, thoracic and mediastinal disorders Acute hypoxic respiratory insufficiency	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Skin and subcutaneous tissue disorders Cellulitis of the right toe	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	50.0% 1/2 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Infections and infestations Soft tissue infection	33.3% 1/3 • Number of events 3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Nervous system disorders Syncope	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	50.0% 1/2 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.

Other adverse events

Other adverse events
Measure	Ph 1 Arm A (AML) Dose 0 n=3 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose 0 n=2 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm A (AML) Dose +1 n=9 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 1 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm A (AML) Dose +1 n=10 participants at risk Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO	Ph 2 Arm B (MDS) Dose + 1 Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 5 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Investigations Creatinine increased	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Investigations Ejection fraction decreased	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Gastrointestinal disorders General disorders and administration site conditions - Other, specify	33.3% 1/3 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	20.0% 2/10 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	50.0% 1/2 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/9 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/10 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
Infections and infestations Sepsis	0.00% 0/3 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	0.00% 0/2 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	11.1% 1/9 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	10.0% 1/10 • Number of events 1 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.	— 0/0 • Up to Two years, 8 months, 30 days There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.

Additional Information

Courtney DiNardo MD, Professor

The university of Texas MD Anderson Cancer Center

Phone: 713-794-1141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place