A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02848001

Enrollment

101

Registered

2016-07-28

Start date

2016-11-14

Completion date

2024-04-11

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

Keywords

CC-90009, Hematologic Cancers, Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, AML, MDS

Brief summary

CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.

Detailed description

Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory higher-risk myelodysplastic syndrome. The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B), will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory higher-risk myelodysplastic syndrome.

Interventions

DRUGCC-90009

CC-90009

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document). 2. Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted. 3. Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) (HR-MDS) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies. 1. In Part A, R/R AML 2. In Part B, R/R AML including * Relapsed after allogeneic HSCT or * In second or later relapse or * Refractory to initial induction or re-induction treatment or * Refractory or relapse after HMA treatment (HMA failure defined as primary progression or lack of clinical benefit after a minimum of 6 cycles or unable to tolerate HMA due to toxicity) or * Refractory within 1 year of initial treatment (excluding those with favorable risk based on cytogenetics) 3. In Part B, R/R HR-MDS (Revised International Prognostic Scoring System score (IPSS-R) \> 3.5 points, IPSS-R calculated during screening period): * IPSS-R intermediate risk (in combination with more than 10% bone marrow blasts or poor or very poor IPSS-R cytogenetic risk) or * IPSS-R high or * IPSS-R very high risk 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2. 5. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning. 6. Subjects must have the following screening laboratory values: * Corrected serum Ca or free (ionized) serum Ca within normal limits (WNL). o Corrected Ca (mg/dL) = Total Ca (mg/dL) - 0.8 (albumin \[g/dL\] - 4) * Total White Blood Cell count (WBC) \< 25 x 10\^9/L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is allowed. * Potassium and magnesium within normal limits or correctable with supplements. * Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN). * Uric acid ≤ 7.5 mg/dL (446 μmol/L). Prior and/or concurrent treatment with hypouricemic agents (eg, allopurinol, rasburicase) are allowed. * Selected electrolytes within normal limits or correctable with supplements. * Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). * Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated. * International normalized ratio (INR) \< 1.5 x ULN and Partial thromboplastin time (PTT) \< 1.5 x ULN.

Exclusion criteria

1. Subjects with acute promyelocytic leukemia (APL) 2. Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is clinical suspicion of CNS involvement by leukemia during screening. 3. Patients with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (e.g., transplant related side effects). 4. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90009. 5. Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). 6. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to control peripheral leukemia blasts. 7. Leukapheresis ≤ 2 weeks prior to starting CC-90009.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Dose Limiting Toxicity (DLTs)	From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)	A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.

Secondary

Measure	Time frame	Description
Change From Baseline by Laboratory Test - Chemistry Parameters 3	From baseline until 28 days post last dose (Up to 25 months)	Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
Non-Tolerated Dose (NTD) of CC-90009	From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)	The NTD is defined as a dose level at which 2 or more of up to 6 evaluable participants in any dose cohort experience a DLT in Cycle 1 during dose escalation (Part A)
Maximum Tolerated Dose (MTD) of CC-90009	From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)	The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable participants experiencing a DLT in Cycle 1 during dose escalation (part A).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose until 28 days post last dose (Up to 25 months)	An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin on or after the start of study drug through 28 days after the last dose of study drug or serious AEs that are suspected of being related to study drug.
Change From Baseline by Laboratory Test - Chemistry Parameters 1	From baseline until 28 days post last dose (Up to 25 months)	Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
Change From Baseline for Vital Signs by Test - Parameters 1	From baseline until 28 days post last dose (Up to 25 months)	Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Change From Baseline for Vital Signs by Test - Parameters 2	From baseline until 28 days post last dose (Up to 25 months)	Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Change From Baseline for Vital Signs by Test - Parameters 3	From baseline until 28 days post last dose (Up to 25 months)	Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Change From Baseline for Vital Signs by Test - Parameters 4	From baseline until 28 days post last dose (Up to 25 months)	Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	From baseline until 28 days post last dose (Up to 25 months)	Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	From baseline until 28 days post last dose (Up to 25 months)	Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
Eastern Cooperative Oncology Group (ECOG) Performance Status	From baseline until 28 days post last dose (Up to 25 months)	Number of participants with post-baseline grade increase or decrease from baseline. Grade 0=; Grade 1=; Grade 2=; Grade 3=; Grade 4=; Grade 5=; . Baseline = last value before start of treatment.
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	From baseline until 28 days post last dose (Up to 25 months)	Left Ventricular Ejection Fraction (LVEF) percent change from baseline. Baseline = last value before start of treatment. Minimum Post Baseline Value=lowest value of the measured parameter is recorded after the baseline measurement. Maximum Post Baseline Value=highest value of the measured parameter is recorded after the baseline measurement.
Objective Response Rate (ORR)	Up to approximately 25 months after the last dose	Objectve response is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission \[CR\] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)) or Morphologic Leukemia - Free State or partial remission. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000/μL, thrombocytopenia \< 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts \<5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
Change From Baseline by Laboratory Test - Chemistry Parameters 2	From baseline until 28 days post last dose (Up to 25 months)	Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
Relapse-free Survival (RFS)	Up to approximately 25 months after the last dose	RFS is defined only for participants who achieved CR or CRi (for AML) / CR or PR (for MDS) and is measured as the interval from the date of first CR or CRi (for AML) / CR or PR (for MDS) to the date of relapse or death from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000 μL, thrombocytopenia \< 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
Progression-free Survival (PFS)	Up to approximately 25 months after the last dose	PFS is defined as the time from the date of the first dose to the date of first relapse after CR/CRi (for AML)/relapse after CR/PR(for MDS), or PD, or death resulting from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000 μL, thrombocytopenia \< 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Event-free Survival (EFS)	Up to approximately 25 months after the last dose	EFS is defined as the interval from the date of the first dose to an event including disease progression (PD), treatment failure, relapse, or death from any cause, whichever occurs first. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Duration of Remission/Response (DOR)	Up to approximately 25 months after the last dose	DOR is defined as the time from first remission/response observed to the date of relapse, death or PD. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Time to Remission/Response (TTR)	Up to approximately 25 months after the last dose	TTR is defined as the time between the date of first dose and the earliest date any remission/response (any complete remissions or partial remissions or better) is observed. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000 μL, thrombocytopenia \< 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts \<5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. Based on Kaplan-Meier Estimates.
Complete Remission Rate (CRR)	Up to approximately 88 months	The complete remission rate (CRR) is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission \[CR\] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)). CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000/μL, thrombocytopenia \< 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts \<5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%, negative EMD.
Time to Acute Myeloid Leukemia (AML) Transformation	Up to approximately 88 months	Time to acute AML transformation in part B Myelodysplastic Syndromes (MDS) participants only. Based on Kaplan-Meier Estimates.
Maximum Observed Plasma Concentration (Cmax)	Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,	Maximum observed plasma concentration, obtained directly from the observed concentration versus time data
Time to Peak Plasma Concentration (Tmax)	Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days	Time to peak plasma concentration, obtained directly from the observed concentration versus time data.
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days	Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose.
Terminal Phase Elimination Half-life (T1/2)	Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days	Terminal phase elimination half-life calculated as \[(ln 2)/λz\], where λz is the apparent terminal rate constant. t1/2 will only be calculated when a reliable estimate for λz can be obtained.
Total Body Clearance (CL)	Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days	Total plasma clearance after IV administration, calculated as \[Dose/ AUC(INF)\] following single administration, and \[Dose/ AUC(0-24)\] at steady state.
Volume of Distribution (Vz)	Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days	Volume of distribution calculated at first dose only. Calculated as \[Vz = Dose/ AUC(INF) \* λz for Day 1\].
Renal Clearance (CLr)	Cycle 1 Day 1(C1D1). 1 cycle = 28 days	Renal clearance of CC-90009 (CLr)
Overall Survival (OS)	Up to approximately 25 months after the last dose	OS is defined as the time from the date of the first dose to the date of death from any cause.

Countries

Canada, France, Norway, Spain, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Part A - 0.3 mg Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	2
Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	2
Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	2
Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	7
Part A - 3.0 mg Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	15
Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	3
Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	8
Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	7
Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	7
Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	9
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	3
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	7
Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	8
Part B - MDS 3.6 mg + DEX Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	2
Part B - AML 2.4 mg Part B - AML CC-90009 2.4 mg (Days 1 - 7 of 28)	9
Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	9
Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)	1
Total	101

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013	FG014	FG015	FG016
Overall Study	Adverse Event	0	0	0	0	2	0	0	0	0	1	0	1	1	0	2	0	0
Overall Study	Death	0	0	0	1	3	1	2	3	4	1	0	1	3	0	2	3	0
Overall Study	Lack of Efficacy	0	1	1	2	3	0	1	0	0	1	0	2	0	2	2	0	0
Overall Study	other reasons	0	0	1	0	4	1	0	2	2	3	0	1	1	0	0	2	1
Overall Study	Physician Decision	0	0	0	0	0	0	0	0	1	1	0	0	2	0	0	0	0
Overall Study	Progressive Disease	2	1	0	4	3	0	4	1	0	2	3	2	1	0	2	4	0
Overall Study	Withdrawal by Subject	0	0	0	0	0	1	1	1	0	0	0	0	0	0	0	0	0

Baseline characteristics

Characteristic	Part A - 0.3 mg	Part A - 0.6 mg	Part A - 1.2 mg	Part A - 2.4 mg	Part A - 3.0 mg	Part A - 3.6 mg	Part A - 3.6 mg + DEX	Part A - 4.5 mg	Part A - 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX	Part B - MDS 3.6 mg + DEX	Part B - AML 2.4 mg	Part B - AML 3.0 mg	Part B - MDS 3.0 mg	Total
Age, Continuous	64.0 Years STANDARD_DEVIATION 8.49	70.0 Years STANDARD_DEVIATION 11.31	60.0 Years STANDARD_DEVIATION 8.49	69.6 Years STANDARD_DEVIATION 8.81	62.2 Years STANDARD_DEVIATION 10.47	71.3 Years STANDARD_DEVIATION 6.81	59.0 Years STANDARD_DEVIATION 20.2	57.3 Years STANDARD_DEVIATION 17.76	66.0 Years STANDARD_DEVIATION 7.05	53.1 Years STANDARD_DEVIATION 18.2	64.3 Years STANDARD_DEVIATION 15.28	63.0 Years STANDARD_DEVIATION 17.01	63.3 Years STANDARD_DEVIATION 4.43	76.5 Years STANDARD_DEVIATION 2.12	66.0 Years STANDARD_DEVIATION 11.05	75.1 Years STANDARD_DEVIATION 7.25	53.0 Years	63.9 Years STANDARD_DEVIATION 13.24
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants	2 Participants	2 Participants	7 Participants	14 Participants	3 Participants	7 Participants	6 Participants	7 Participants	9 Participants	3 Participants	6 Participants	7 Participants	2 Participants	6 Participants	7 Participants	1 Participants	90 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	5 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	13 Participants
Race (NIH/OMB) White	2 Participants	1 Participants	1 Participants	3 Participants	13 Participants	3 Participants	6 Participants	6 Participants	7 Participants	8 Participants	2 Participants	5 Participants	6 Participants	2 Participants	6 Participants	7 Participants	1 Participants	79 Participants
Sex: Female, Male Female	1 Participants	2 Participants	0 Participants	2 Participants	2 Participants	1 Participants	1 Participants	3 Participants	3 Participants	4 Participants	1 Participants	3 Participants	4 Participants	0 Participants	2 Participants	4 Participants	0 Participants	33 Participants
Sex: Female, Male Male	1 Participants	0 Participants	2 Participants	5 Participants	13 Participants	2 Participants	7 Participants	4 Participants	4 Participants	5 Participants	2 Participants	4 Participants	4 Participants	2 Participants	7 Participants	5 Participants	1 Participants	68 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk
deaths Total, all-cause mortality	2 / 2	2 / 2	2 / 2	7 / 7	14 / 15	2 / 3	8 / 8	6 / 7	7 / 7	7 / 9	2 / 3	7 / 7	8 / 8	2 / 2	9 / 9	9 / 9	0 / 1
other Total, other adverse events	2 / 2	2 / 2	2 / 2	7 / 7	15 / 15	3 / 3	8 / 8	7 / 7	7 / 7	9 / 9	3 / 3	7 / 7	8 / 8	2 / 2	8 / 9	9 / 9	1 / 1
serious Total, serious adverse events	0 / 2	0 / 2	1 / 2	6 / 7	15 / 15	3 / 3	7 / 8	7 / 7	7 / 7	6 / 9	3 / 3	6 / 7	8 / 8	1 / 2	9 / 9	8 / 9	0 / 1

Outcome results

Primary

Number of Participants With Dose Limiting Toxicity (DLTs)

A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.

Time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)

Population: All treated participants in dose escalation (Part A)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A - 0.3 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	0 Participants
Part A - 0.6 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	0 Participants
Part A - 1.2 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	0 Participants
Part A - 2.4 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	1 Participants
Part A - 3.0 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	1 Participants
Part A - 3.6 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	2 Participants
Part A - 3.6 mg + DEX	Number of Participants With Dose Limiting Toxicity (DLTs)	1 Participants
Part A - 4.5 mg	Number of Participants With Dose Limiting Toxicity (DLTs)	2 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Number of Participants With Dose Limiting Toxicity (DLTs)	1 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Number of Participants With Dose Limiting Toxicity (DLTs)	2 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Dose Limiting Toxicity (DLTs)	0 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Dose Limiting Toxicity (DLTs)	1 Participants

Secondary

Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)

Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose.

Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part A - 0.3 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	22.93 h*ng/mL	Geometric Coefficient of Variation 33.59
Part A - 0.3 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	26.94 h*ng/mL	Geometric Coefficient of Variation 35.62
Part A - 0.6 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	141.84 h*ng/mL	Geometric Coefficient of Variation 99.49
Part A - 0.6 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	110.11 h*ng/mL	Geometric Coefficient of Variation 68.8
Part A - 1.2 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	121.06 h*ng/mL	Geometric Coefficient of Variation 111.97
Part A - 1.2 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	142.54 h*ng/mL	Geometric Coefficient of Variation 148.76
Part A - 2.4 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	323.10 h*ng/mL	Geometric Coefficient of Variation 75.44
Part A - 2.4 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	769.03 h*ng/mL	Geometric Coefficient of Variation 25.72
Part A - 3.0 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	536.30 h*ng/mL	Geometric Coefficient of Variation 39.55
Part A - 3.0 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	382.59 h*ng/mL	Geometric Coefficient of Variation 37.6
Part A - 3.6 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	1360.00 h*ng/mL	—
Part A - 3.6 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	486.47 h*ng/mL	Geometric Coefficient of Variation 70.83
Part A - 3.6 mg + DEX	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	333.79 h*ng/mL	Geometric Coefficient of Variation 25.04
Part A - 3.6 mg + DEX	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	624.30 h*ng/mL	Geometric Coefficient of Variation 55.31
Part A - 4.5 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D5	669.55 h*ng/mL	Geometric Coefficient of Variation 23.92
Part A - 4.5 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	723.89 h*ng/mL	Geometric Coefficient of Variation 30.43
Part A - 3.6 mg (Days 1 - 7 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	618.99 h*ng/mL	Geometric Coefficient of Variation 64.81
Part A - 3.6 mg (Days 1 - 7 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D7	959.76 h*ng/mL	Geometric Coefficient of Variation 80.24
Part A - 3.0 mg (Days 1- 10 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	371.58 h*ng/mL	Geometric Coefficient of Variation 87.8
Part A - 3.0 mg (Days 1- 10 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D10	777.69 h*ng/mL	Geometric Coefficient of Variation 14.64
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	304.37 h*ng/mL	Geometric Coefficient of Variation 43.55
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D8	422.26 h*ng/mL	Geometric Coefficient of Variation 41.02
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D8	648.01 h*ng/mL	Geometric Coefficient of Variation 35.29
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	487.14 h*ng/mL	Geometric Coefficient of Variation 69.15
Part B - AML 3.6 mg + DEX	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	835.2 h*ng/mL	Geometric Coefficient of Variation 66.9
Part B - MDS 3.6 mg + DEX	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	790.5 h*ng/mL	Geometric Coefficient of Variation 250.4
Part B - AML 2.4 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D7	369.61 h*ng/mL	Geometric Coefficient of Variation 48.65
Part B - AML 2.4 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	245.53 h*ng/mL	Geometric Coefficient of Variation 67.51
Part B - AML 3.0 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D7	409.43 h*ng/mL	Geometric Coefficient of Variation 54.13
Part B - AML 3.0 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	270.49 h*ng/mL	Geometric Coefficient of Variation 102.71
Part B - MDS 3.0 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D7	425.00 h*ng/mL	—
Part B - MDS 3.0 mg	Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)	C1D1	188.00 h*ng/mL	—

Secondary

Change From Baseline by Laboratory Test - Chemistry Parameters 1

Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-11.0000 g/L	Standard Deviation 5.65685
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	6.5000 g/L	Standard Deviation 4.94975
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	8.5000 g/L	Standard Deviation 6.36396
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-6.0000 g/L	Standard Deviation 0
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	10.5000 g/L	Standard Deviation 7.77817
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-1.0000 g/L	Standard Deviation 4.24264
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	0.0000 g/L	Standard Deviation 1.41421
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	13.5000 g/L	Standard Deviation 7.77817
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-13.0000 g/L	Standard Deviation 1.41421
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	4.5000 g/L	Standard Deviation 4.94975
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	2.0000 g/L	Standard Deviation 2.82843
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-9.5000 g/L	Standard Deviation 2.12132
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	4.2143 g/L	Standard Deviation 3.16039
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-9.7143 g/L	Standard Deviation 5.31395
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-3.9286 g/L	Standard Deviation 3.27145
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	5.7143 g/L	Standard Deviation 6.1023
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-9.8000 g/L	Standard Deviation 6.82642
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	1.7333 g/L	Standard Deviation 7.43031
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	122.8667 g/L	Standard Deviation 449.87615
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-12.8667 g/L	Standard Deviation 4.43793
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	7.0000 g/L	Standard Deviation 6.08276
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-20.6667 g/L	Standard Deviation 9.50438
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-11.3333 g/L	Standard Deviation 2.51661
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	7.6667 g/L	Standard Deviation 5.1316
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	6.8750 g/L	Standard Deviation 7.0799
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	4.6250 g/L	Standard Deviation 3.20435
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-7.7500 g/L	Standard Deviation 4.65219
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-12.2500 g/L	Standard Deviation 5.39179
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	3.4286 g/L	Standard Deviation 3.6904
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-12.2857 g/L	Standard Deviation 6.29058
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	4.2857 g/L	Standard Deviation 5.25085
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-16.5714 g/L	Standard Deviation 3.86683
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	2.1429 g/L	Standard Deviation 4.41318
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-9.8571 g/L	Standard Deviation 4.74091
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	2.7143 g/L	Standard Deviation 4.2314
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-18.4286 g/L	Standard Deviation 5.19157
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-16.8889 g/L	Standard Deviation 8.00694
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-9.3333 g/L	Standard Deviation 3.57071
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	4.2222 g/L	Standard Deviation 6.86982
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	2.8889 g/L	Standard Deviation 3.75648
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-12.0000 g/L	Standard Deviation 3.60555
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	7.3333 g/L	Standard Deviation 4.93288
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	4.3333 g/L	Standard Deviation 1.52753
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-7.6667 g/L	Standard Deviation 4.04145
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-9.8571 g/L	Standard Deviation 4.84522
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-6.5714 g/L	Standard Deviation 3.99404
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	6.0000 g/L	Standard Deviation 2.94392
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	3.4286 g/L	Standard Deviation 2.93582
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-9.6250 g/L	Standard Deviation 5.73056
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-16.7500 g/L	Standard Deviation 8.11964
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	0.1250 g/L	Standard Deviation 4.61171
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	1.6250 g/L	Standard Deviation 3.11391
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	0.5000 g/L	Standard Deviation 4.94975
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-16.0000 g/L	Standard Deviation 8.48528
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	4.5000 g/L	Standard Deviation 2.12132
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-14.5000 g/L	Standard Deviation 12.02082
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	5.7375 g/L	Standard Deviation 4.72469
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-10.6750 g/L	Standard Deviation 3.67064
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	5.0444 g/L	Standard Deviation 2.56861
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-4.2778 g/L	Standard Deviation 4.29062
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	5.6250 g/L	Standard Deviation 5.01248
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-5.9444 g/L	Standard Deviation 2.55495
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-10.7500 g/L	Standard Deviation 5.06388
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	4.0778 g/L	Standard Deviation 3.25645
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Maximum Post Baseline Value	8.0000 g/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Maximum Post Baseline Value	13.0000 g/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Protein Minimum Post Baseline Value	-3.0000 g/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 1	Albumin Minimum Post Baseline Value	-2.0000 g/L	—

Secondary

Change From Baseline by Laboratory Test - Chemistry Parameters 2

Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-6.0000 U/L	Standard Deviation 5.65685
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	4.5000 U/L	Standard Deviation 9.19239
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-23.0000 U/L	Standard Deviation 16.97056
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	11.5000 U/L	Standard Deviation 6.36396
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-8.0000 U/L	Standard Deviation 8.48528
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	2.5000 U/L	Standard Deviation 3.53553
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-4.5000 U/L	Standard Deviation 0.70711
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	7.5000 U/L	Standard Deviation 2.12132
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	17.5000 U/L	Standard Deviation 3.53553
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	23.5000 U/L	Standard Deviation 13.43503
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	60.0000 U/L	Standard Deviation 89.09545
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-4.5000 U/L	Standard Deviation 4.94975
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	207.0000 U/L	Standard Deviation 282.84271
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	85.5000 U/L	Standard Deviation 67.17514
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-5.0000 U/L	Standard Deviation 7.07107
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-1.5000 U/L	Standard Deviation 2.12132
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-12.7500 U/L	Standard Deviation 8.13173
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	1.5000 U/L	Standard Deviation 3.53553
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	16.2500 U/L	Standard Deviation 6.01041
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-9.7500 U/L	Standard Deviation 2.47487
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	24.2500 U/L	Standard Deviation 7.42462
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-26.7500 U/L	Standard Deviation 20.85965
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	14.2500 U/L	Standard Deviation 13.08148
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-7.0000 U/L	Standard Deviation 8.48528
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	104.7143 U/L	Standard Deviation 135.05766
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	4.1429 U/L	Standard Deviation 57.68428
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	84.1429 U/L	Standard Deviation 82.69105
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-1.8571 U/L	Standard Deviation 4.63424
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-1.6429 U/L	Standard Deviation 20.2211
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	1.8333 U/L	Standard Deviation 15.71517
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	0.8333 U/L	Standard Deviation 15.81666
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	63.7857 U/L	Standard Deviation 42.385
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-27.9333 U/L	Standard Deviation 25.4852
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-11.6000 U/L	Standard Deviation 16.83024
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	7.6364 U/L	Standard Deviation 28.68893
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	14.4545 U/L	Standard Deviation 27.40206
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	49.4000 U/L	Standard Deviation 45.70839
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	143.3333 U/L	Standard Deviation 353.35629
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-7.8667 U/L	Standard Deviation 10.94706
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	73.8000 U/L	Standard Deviation 71.88304
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	38.0000 U/L	Standard Deviation 14.10674
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-23.3333 U/L	Standard Deviation 14.57166
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	11.26943 U/L	Standard Deviation 14
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	78.0000 U/L	Standard Deviation 84.43341
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-29.6667 U/L	Standard Deviation 40.2782
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	21.0000 U/L	—
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	55.3333 U/L	Standard Deviation 10.96966
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-4.0000 U/L	—
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	95.7500 U/L	Standard Deviation 105.06019
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	12.1667 U/L	Standard Deviation 20.28218
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-3.3750 U/L	Standard Deviation 11.17315
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	117.7500 U/L	Standard Deviation 64.07083
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	12.0000 U/L	Standard Deviation 20.34699
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-55.6250 U/L	Standard Deviation 101.06142
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-9.8750 U/L	Standard Deviation 13.37842
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	95.7500 U/L	Standard Deviation 123.57733
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-52.4286 U/L	Standard Deviation 66.26678
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	72.7143 U/L	Standard Deviation 80.35487
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-3.5714 U/L	Standard Deviation 21.6245
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	150.1429 U/L	Standard Deviation 136.43488
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-12.7500 U/L	Standard Deviation 19.6023
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	17.0000 U/L	Standard Deviation 18.67262
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-10.2857 U/L	Standard Deviation 12.41926
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	151.2857 U/L	Standard Deviation 282.47992
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-57.8571 U/L	Standard Deviation 68.82448
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	95.1429 U/L	Standard Deviation 46.31209
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	138.8571 U/L	Standard Deviation 239.39815
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-1.5714 U/L	Standard Deviation 2.29907
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	0.0000 U/L	Standard Deviation 23.93045
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	8.5000 U/L	Standard Deviation 21.56386
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-4.2857 U/L	Standard Deviation 6.23737
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	72.5714 U/L	Standard Deviation 57.86149
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-0.3333 U/L	Standard Deviation 9.44722
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	27.2222 U/L	Standard Deviation 24.80815
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	4.5000 U/L	Standard Deviation 10.84743
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	145.8889 U/L	Standard Deviation 141.73077
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-1.6667 U/L	Standard Deviation 6.80074
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	74.1111 U/L	Standard Deviation 71.85479
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	0.7500 U/L	Standard Deviation 14.31491
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-15.6667 U/L	Standard Deviation 19
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	2.6667 U/L	Standard Deviation 45.08141
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	280.3333 U/L	Standard Deviation 324.62491
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-13.3333 U/L	Standard Deviation 28.36077
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	293.0000 U/L	Standard Deviation 309.5109
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	294.3333 U/L	Standard Deviation 402.47898
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-7.6667 U/L	Standard Deviation 7.0946
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-22.0000 U/L	Standard Deviation 20.07486
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-4.0000 U/L	Standard Deviation 3.60555
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	47.8571 U/L	Standard Deviation 39.29982
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	20.1667 U/L	Standard Deviation 26.11832
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-17.7143 U/L	Standard Deviation 18.56264
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	32.8571 U/L	Standard Deviation 36.56241
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	22.0000 U/L	Standard Deviation 24.23221
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	49.7143 U/L	Standard Deviation 40.91338
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-8.1429 U/L	Standard Deviation 9.09997
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-6.1429 U/L	Standard Deviation 5.66947
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	70.0000 U/L	Standard Deviation 110.09476
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	81.5 U/L	Standard Deviation 171.64
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-4.0000 U/L	Standard Deviation 3
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-12.6250 U/L	Standard Deviation 15.17458
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	-4.0000 U/L	Standard Deviation 3
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	19.2500 U/L	Standard Deviation 18.85092
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-8.9 U/L	Standard Deviation 7.26
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-18.6250 U/L	Standard Deviation 10.50085
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	38.0000 U/L	Standard Deviation 11.31371
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	25.0 U/L	Standard Deviation 2.83
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-8.5000 U/L	Standard Deviation 2.12132
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-7.5 U/L	Standard Deviation 0.71
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	8.0000 U/L	Standard Deviation 7.07107
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	34.0000 U/L	Standard Deviation 8.48528
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-14.5000 U/L	Standard Deviation 0.70711
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-4.0000 U/L	Standard Deviation 8.48528
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-25.5222 U/L	Standard Deviation 51.2038
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-2.8889 U/L	Standard Deviation 5.81903
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	20.0000 U/L	Standard Deviation 46.32926
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	63.2222 U/L	Standard Deviation 92.1965
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	49.3333 U/L	Standard Deviation 59.21571
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	78.4444 U/L	Standard Deviation 89.89176
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-3.6667 U/L	Standard Deviation 5.02494
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	19.6667 U/L	Standard Deviation 46.16348
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	39.5556 U/L	Standard Deviation 45.42057
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	52.8889 U/L	Standard Deviation 40.26613
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	-11.6000 U/L	Standard Deviation 27.71823
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	-18.8000 U/L	Standard Deviation 25.50882
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-4.6667 U/L	Standard Deviation 5.70088
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-9.7778 U/L	Standard Deviation 12.80408
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-10.6667 U/L	Standard Deviation 13.0384
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	30.0000 U/L	Standard Deviation 23.53189
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-12.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	299.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-8.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Minimum Post Baseline Value	13.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Maximum Post Baseline Value	349.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Amylase (Serum) Maximum Post Baseline Value	17.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alkaline Phosphatase (Serum) Maximum Post Baseline Value	24.0000 U/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 2	Alanine Aminotransferase (Serum) Minimum Post Baseline Value	1.0000 U/L	—

Secondary

Change From Baseline by Laboratory Test - Chemistry Parameters 3

Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.0661 mmol/L	Standard Deviation 0.02277
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-7.0000 mmol/L	Standard Deviation 2.82843
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.1250 mmol/L	Standard Deviation 0.02121
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0225 mmol/L	—
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	0.0000 mmol/L	—
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.4757 mmol/L	Standard Deviation 0.14948
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	1.0000 mmol/L	Standard Deviation 0
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	5.00 mmol/L	—
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.5000 mmol/L	Standard Deviation 0.28284
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1550 mmol/L	Standard Deviation 0.00707
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-4.5000 mmol/L	Standard Deviation 0.70711
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	0.0225 mmol/L	—
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-6.00 mmol/L	—
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1678 mmol/L	Standard Deviation 0.05339
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-0.7333 mmol/L	Standard Deviation 0.80151
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.5500 mmol/L	Standard Deviation 0.07071
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	3.5000 mmol/L	Standard Deviation 0.70711
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	2.4780 mmol/L	Standard Deviation 0.53457
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-2.1640 mmol/L	Standard Deviation 1.04086
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	5.0000 mmol/L	—
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	2.6098 mmol/L	Standard Deviation 0.15521
Part A - 0.3 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.1396 mmol/L	Standard Deviation 0.01471
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	2.4698 mmol/L	Standard Deviation 2.62938
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	2.5000 mmol/L	Standard Deviation 2.12132
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-9.5000 mmol/L	Standard Deviation 4.94975
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2466 mmol/L	Standard Deviation 0.29062
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.7205 mmol/L	Standard Deviation 0.78489
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.6500 mmol/L	Standard Deviation 0.6364
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-4.0000 mmol/L	Standard Deviation 1.41421
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.1350 mmol/L	Standard Deviation 0.01414
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-0.8925 mmol/L	Standard Deviation 1.76706
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	4.00 mmol/L	Standard Deviation 0
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.5000 mmol/L	Standard Deviation 0.28284
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1475 mmol/L	Standard Deviation 0.10253
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.3715 mmol/L	Standard Deviation 0.1142
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-3.00 mmol/L	Standard Deviation 0
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.0822 mmol/L	Standard Deviation 0.11625
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	4.9980 mmol/L	Standard Deviation 2.0195
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.0485 mmol/L	Standard Deviation 0.06852
Part A - 0.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	0.5000 mmol/L	Standard Deviation 3.53553
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-7.5000 mmol/L	Standard Deviation 4.94975
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.6750 mmol/L	Standard Deviation 0.53033
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-4.00 mmol/L	Standard Deviation 4.243
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.3069 mmol/L	Standard Deviation 0.06852
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-2.1229 mmol/L	Standard Deviation 0.80451
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.2025 mmol/L	Standard Deviation 0.21567
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	5.1765 mmol/L	Standard Deviation 0.75731
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.2225 mmol/L	—
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.0514 mmol/L	Standard Deviation 0.07266
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-5.0000 mmol/L	Standard Deviation 1.41421
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0150 mmol/L	—
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1747 mmol/L	Standard Deviation 0.04359
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.2350 mmol/L	Standard Deviation 0.14849
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	3.5000 mmol/L	Standard Deviation 0.70711
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.2250 mmol/L	Standard Deviation 0.17678
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-2.1420 mmol/L	Standard Deviation 1.51462
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	6.5000 mmol/L	Standard Deviation 3.53553
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	7.00 mmol/L	Standard Deviation 2.828
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.4684 mmol/L	Standard Deviation 0.38827
Part A - 1.2 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	5.8136 mmol/L	Standard Deviation 2.02109
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.2033 mmol/L	Standard Deviation 0.05774
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.9180 mmol/L	Standard Deviation 1.23345
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.7822 mmol/L	Standard Deviation 1.22271
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.9457 mmol/L	Standard Deviation 0.7554
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	5.50 mmol/L	Standard Deviation 7.089
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.7286 mmol/L	Standard Deviation 0.47859
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-7.83 mmol/L	Standard Deviation 5.393
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	5.0000 mmol/L	Standard Deviation 3.3665
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1325 mmol/L	Standard Deviation 0.09877
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-4.4286 mmol/L	Standard Deviation 2.37045
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.3527 mmol/L	Standard Deviation 0.17041
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	2.4246 mmol/L	Standard Deviation 2.08954
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	-0.0350 mmol/L	Standard Deviation 0.09124
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.6302 mmol/L	Standard Deviation 0.26517
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1064 mmol/L	Standard Deviation 0.20428
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.7003 mmol/L	Standard Deviation 0.496
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4614 mmol/L	Standard Deviation 0.1894
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-5.4286 mmol/L	Standard Deviation 2.50713
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	1.0000 mmol/L	Standard Deviation 1.41421
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-8.5000 mmol/L	Standard Deviation 1.29099
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	2.7143 mmol/L	Standard Deviation 3.25137
Part A - 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	6.8120 mmol/L	Standard Deviation 6.77422
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.7392 mmol/L	Standard Deviation 0.61769
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2818 mmol/L	Standard Deviation 0.14292
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-7.1333 mmol/L	Standard Deviation 7.98093
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.3386 mmol/L	Standard Deviation 0.42193
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.5400 mmol/L	Standard Deviation 0.35416
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.1558 mmol/L	Standard Deviation 0.27691
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	3.0881 mmol/L	Standard Deviation 2.37534
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1434 mmol/L	Standard Deviation 0.15976
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4643 mmol/L	Standard Deviation 0.19304
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.4420 mmol/L	Standard Deviation 1.63613
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	7.02 mmol/L	Standard Deviation 8.784
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	9.4000 mmol/L	Standard Deviation 8.64209
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-10.1333 mmol/L	Standard Deviation 24.80169
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.9303 mmol/L	Standard Deviation 1.73875
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.5801 mmol/L	Standard Deviation 0.28215
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1757 mmol/L	Standard Deviation 0.11539
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	8.3157 mmol/L	Standard Deviation 4.35216
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-7.5143 mmol/L	Standard Deviation 3.49401
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-6.15 mmol/L	Standard Deviation 2.716
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	4.6667 mmol/L	Standard Deviation 4.13464
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.7000 mmol/L	Standard Deviation 0.56821
Part A - 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	2.1857 mmol/L	Standard Deviation 2.18893
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.3700 mmol/L	—
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	5.3333 mmol/L	Standard Deviation 6.50641
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.7752 mmol/L	Standard Deviation 0.43455
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.0685 mmol/L	Standard Deviation 0.06278
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	11.6667 mmol/L	Standard Deviation 3.05505
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.0917 mmol/L	Standard Deviation 0.14216
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	5.9755 mmol/L	Standard Deviation 5.04847
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.5276 mmol/L	Standard Deviation 0.57448
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.7000 mmol/L	Standard Deviation 0.98489
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-7.33 mmol/L	Standard Deviation 2.082
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4750 mmol/L	Standard Deviation 0.30311
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	2.67 mmol/L	Standard Deviation 2.082
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-4.0000 mmol/L	Standard Deviation 3.60555
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.6667 mmol/L	Standard Deviation 0.40415
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	-2.0000 mmol/L	—
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	9.5200 mmol/L	Standard Deviation 8.51827
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-3.0000 mmol/L	—
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-2.0165 mmol/L	Standard Deviation 1.28292
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.7850 mmol/L	Standard Deviation 0.94453
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2466 mmol/L	Standard Deviation 0.1233
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	-0.0200 mmol/L	—
Part A - 3.6 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-5.0000 mmol/L	Standard Deviation 5.2915
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.6085 mmol/L	Standard Deviation 0.28717
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.7267 mmol/L	Standard Deviation 1.12065
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.2740 mmol/L	Standard Deviation 0.4451
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.4625 mmol/L	Standard Deviation 0.27223
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-4.0250 mmol/L	Standard Deviation 2.30416
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.2220 mmol/L	Standard Deviation 0.08831
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	5.0000 mmol/L	Standard Deviation 2.56348
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	3.3750 mmol/L	Standard Deviation 5.65528
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1431 mmol/L	Standard Deviation 0.16641
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1816 mmol/L	Standard Deviation 0.11047
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	6.6410 mmol/L	Standard Deviation 12.50771
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-8.92 mmol/L	Standard Deviation 5.788
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-7.3750 mmol/L	Standard Deviation 4.77905
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	4.88 mmol/L	Standard Deviation 5.841
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.6106 mmol/L	Standard Deviation 0.29461
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.8750 mmol/L	Standard Deviation 0.58737
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	9.7553 mmol/L	Standard Deviation 5.39524
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.6354 mmol/L	Standard Deviation 0.51976
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.1397 mmol/L	Standard Deviation 0.15729
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-6.1250 mmol/L	Standard Deviation 2.53194
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.6767 mmol/L	Standard Deviation 1.92439
Part A - 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	6.8250 mmol/L	Standard Deviation 4.57265
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.5723 mmol/L	Standard Deviation 0.25444
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	6.6956 mmol/L	Standard Deviation 4.61321
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.8214 mmol/L	Standard Deviation 0.34139
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.6071 mmol/L	Standard Deviation 0.32968
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1621 mmol/L	Standard Deviation 0.12041
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2115 mmol/L	Standard Deviation 0.17599
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	1.1399 mmol/L	Standard Deviation 0.73804
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-6.4286 mmol/L	Standard Deviation 2.22539
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	2.4286 mmol/L	Standard Deviation 3.10146
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.3615 mmol/L	Standard Deviation 1.8778
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	13.6523 mmol/L	Standard Deviation 8.34637
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-5.0333 mmol/L	Standard Deviation 1.00167
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	2.3000 mmol/L	Standard Deviation 1.75784
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.5136 mmol/L	Standard Deviation 0.133
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1157 mmol/L	Standard Deviation 0.13148
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.3242 mmol/L	Standard Deviation 0.33363
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	-0.0138 mmol/L	Standard Deviation 0.10585
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-5.5714 mmol/L	Standard Deviation 2.93582
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	5.4286 mmol/L	Standard Deviation 3.40867
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-13.12 mmol/L	Standard Deviation 7.367
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	2.06 mmol/L	Standard Deviation 3.531
Part A - 4.5 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.2917 mmol/L	Standard Deviation 2.58471
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-5.0000 mmol/L	Standard Deviation 1.1547
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.5857 mmol/L	Standard Deviation 0.55806
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-10.18 mmol/L	Standard Deviation 4.032
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-0.7142 mmol/L	Standard Deviation 1.10594
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-11.8675 mmol/L	Standard Deviation 9.78371
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	10.7143 mmol/L	Standard Deviation 7.99405
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	0.8500 mmol/L	Standard Deviation 2.54755
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.3589 mmol/L	Standard Deviation 1.65079
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	4.2604 mmol/L	Standard Deviation 3.84923
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.6050 mmol/L	Standard Deviation 0.22163
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	14.8533 mmol/L	Standard Deviation 9.9493
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.8597 mmol/L	Standard Deviation 0.91607
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.2175 mmol/L	Standard Deviation 0.07777
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.4597 mmol/L	Standard Deviation 0.38489
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.3950 mmol/L	Standard Deviation 0.23569
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	17.3332 mmol/L	Standard Deviation 45.22988
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	1.25 mmol/L	Standard Deviation 3.304
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2198 mmol/L	Standard Deviation 0.21791
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-1.0571 mmol/L	Standard Deviation 0.29921
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-15.4286 mmol/L	Standard Deviation 29.94916
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1554 mmol/L	Standard Deviation 0.13947
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	5.7143 mmol/L	Standard Deviation 6.04743
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	3.93 mmol/L	Standard Deviation 3.622
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.6305 mmol/L	Standard Deviation 0.2501
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	1.6667 mmol/L	Standard Deviation 1.58114
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.1995 mmol/L	Standard Deviation 2.01204
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1417 mmol/L	Standard Deviation 0.20335
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-0.3899 mmol/L	Standard Deviation 1.35398
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4367 mmol/L	Standard Deviation 0.10256
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.8667 mmol/L	Standard Deviation 0.53852
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2259 mmol/L	Standard Deviation 0.11524
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	5.1111 mmol/L	Standard Deviation 3.10018
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1364 mmol/L	Standard Deviation 0.11191
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-9.59 mmol/L	Standard Deviation 4.171
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0592 mmol/L	Standard Deviation 0.09937
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.3119 mmol/L	Standard Deviation 0.55165
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.2364 mmol/L	Standard Deviation 0.10346
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-7.4500 mmol/L	Standard Deviation 3.97492
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.3111 mmol/L	Standard Deviation 0.32189
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	11.0090 mmol/L	Standard Deviation 3.89546
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-6.8889 mmol/L	Standard Deviation 2.848
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-5.1111 mmol/L	Standard Deviation 3.4801
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	3.1375 mmol/L	Standard Deviation 3.55163
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	4.0611 mmol/L	Standard Deviation 2.96891
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-7.0000 mmol/L	Standard Deviation 1
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-1.1000 mmol/L	Standard Deviation 0.36056
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	-0.0283 mmol/L	Standard Deviation 0.11361
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	10.5890 mmol/L	Standard Deviation 13.37754
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	4.3333 mmol/L	Standard Deviation 1.1547
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-4.1000 mmol/L	Standard Deviation 1.90526
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-1.0614 mmol/L	Standard Deviation 0.37317
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-3.0000 mmol/L	Standard Deviation 1
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1742 mmol/L	Standard Deviation 0.11591
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	3.3685 mmol/L	Standard Deviation 1.95592
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	25.20 mmol/L	Standard Deviation 5.374
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	1.6667 mmol/L	Standard Deviation 2.08167
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.1604 mmol/L	Standard Deviation 0.12659
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.0392 mmol/L	Standard Deviation 0.12539
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-0.9662 mmol/L	Standard Deviation 0.69337
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.8114 mmol/L	Standard Deviation 0.77173
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.5350 mmol/L	Standard Deviation 0.11034
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-3.00 mmol/L	Standard Deviation 2.404
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.4000 mmol/L	Standard Deviation 0.43589
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	2.5667 mmol/L	Standard Deviation 3.48473
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	10.5656 mmol/L	Standard Deviation 5.62941
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.5257 mmol/L	Standard Deviation 0.79291
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0989 mmol/L	Standard Deviation 0.11111
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	24.8000 mmol/L	Standard Deviation 47.6
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-5.4286 mmol/L	Standard Deviation 2.82
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	2.5714 mmol/L	Standard Deviation 0.9759
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.6580 mmol/L	Standard Deviation 0.48893
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4500 mmol/L	Standard Deviation 0.22224
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-5.8750 mmol/L	Standard Deviation 2.32289
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-0.8080 mmol/L	Standard Deviation 1.44364
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	5.6909 mmol/L	Standard Deviation 4.2031
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-5.5714 mmol/L	Standard Deviation 2.69921
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.2026 mmol/L	Standard Deviation 1.14734
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.0957 mmol/L	Standard Deviation 0.11002
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.7286 mmol/L	Standard Deviation 0.85579
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-7.67 mmol/L	Standard Deviation 1.528
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.7058 mmol/L	Standard Deviation 0.31457
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.7857 mmol/L	Standard Deviation 0.29681
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1289 mmol/L	Standard Deviation 0.12833
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	0.67 mmol/L	Standard Deviation 2.082
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.2696 mmol/L	Standard Deviation 0.12539
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	5.4286 mmol/L	Standard Deviation 4.57738
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	10.1050 mmol/L	Standard Deviation 7.49087
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-3.87 mmol/L	Standard Deviation 3.308
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-2.6250 mmol/L	Standard Deviation 3.42
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	4.98 mmol/L	Standard Deviation 3.305
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.8600 mmol/L	Standard Deviation 0.82275
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-3.1250 mmol/L	Standard Deviation 4.58063
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4425 mmol/L	Standard Deviation 0.14071
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	4.5039 mmol/L	Standard Deviation 5.49686
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.4598 mmol/L	Standard Deviation 0.50333
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1063 mmol/L	Standard Deviation 0.10374
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	3.5200 mmol/L	Standard Deviation 4.35282
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-2.7784 mmol/L	Standard Deviation 3.30908
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.1971 mmol/L	Standard Deviation 0.05376
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2620 mmol/L	Standard Deviation 0.24586
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0643 mmol/L	Standard Deviation 0.08204
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.6875 mmol/L	Standard Deviation 0.58661
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	4.5000 mmol/L	Standard Deviation 4.47214
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	6.0000 mmol/L	Standard Deviation 5.58058
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-0.2616 mmol/L	Standard Deviation 1.46975
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-5.5600 mmol/L	Standard Deviation 6.65004
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.7125 mmol/L	Standard Deviation 0.44219
Part B - AML 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.0969 mmol/L	Standard Deviation 0.07597
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.7213 mmol/L	Standard Deviation 0.26447
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.5275 mmol/L	Standard Deviation 0.20506
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.6450 mmol/L	Standard Deviation 0.13435
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	6.0000 mmol/L	Standard Deviation 2.82843
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.4684 mmol/L	Standard Deviation 0.29691
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-8.5000 mmol/L	Standard Deviation 2.12132
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	2.5000 mmol/L	Standard Deviation 3.53553
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-8.0000 mmol/L	Standard Deviation 4.24264
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.0300 mmol/L	Standard Deviation 0.19799
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.5168 mmol/L	Standard Deviation 0.31975
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	5.49686 mmol/L	Standard Deviation 2.27618
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.0822 mmol/L	Standard Deviation 0.05812
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-3.7485 mmol/L	Standard Deviation 1.26219
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.5500 mmol/L	Standard Deviation 0.49497
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	11.4240 mmol/L	Standard Deviation 0.50487
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-4.5000 mmol/L	Standard Deviation 0.70711
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.7500 mmol/L	Standard Deviation 0.35355
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	-0.0438 mmol/L	Standard Deviation 0.10076
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	0.0000 mmol/L	Standard Deviation 1.41421
Part B - MDS 3.6 mg + DEX	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-1.6650 mmol/L	Standard Deviation 2.04071
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	2.6778 mmol/L	Standard Deviation 2.53662
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	7.6687 mmol/L	Standard Deviation 2.92428
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-4.4111 mmol/L	Standard Deviation 2.97844
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-3.3500 mmol/L	Standard Deviation 2.59936
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	3.2500 mmol/L	Standard Deviation 2.62996
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.6059 mmol/L	Standard Deviation 0.33589
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4800 mmol/L	Standard Deviation 0.12119
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.4614 mmol/L	Standard Deviation 0.29484
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.0740 mmol/L	Standard Deviation 0.09397
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.1815 mmol/L	Standard Deviation 0.1091
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2454 mmol/L	Standard Deviation 0.16916
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0575 mmol/L	Standard Deviation 0.13083
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.0995 mmol/L	Standard Deviation 0.07483
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-2.0524 mmol/L	Standard Deviation 1.98069
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-4.1889 mmol/L	Standard Deviation 3.81394
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.4933 mmol/L	Standard Deviation 0.52192
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	3.6333 mmol/L	Standard Deviation 3.39264
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-5.2333 mmol/L	Standard Deviation 4.26224
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.5000 mmol/L	Standard Deviation 0.3
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	1.7500 mmol/L	Standard Deviation 1.99374
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	2.5520 mmol/L	Standard Deviation 3.08923
Part B - AML 2.4 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-1.4423 mmol/L	Standard Deviation 2.08076
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-3.8089 mmol/L	Standard Deviation 4.81888
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	8.1828 mmol/L	Standard Deviation 4.82377
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-5.5000 mmol/L	Standard Deviation 2.38048
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	15.2000 mmol/L	Standard Deviation 44.25113
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-14.4444 mmol/L	Standard Deviation 21.11345
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.0616 mmol/L	Standard Deviation 0.06859
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.5025 mmol/L	Standard Deviation 0.62937
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.0820 mmol/L	Standard Deviation 0.67998
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.2256 mmol/L	Standard Deviation 0.12779
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Maximum Post Baseline Value	0.1630 mmol/L	Standard Deviation 0.06676
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	3.0000 mmol/L	Standard Deviation 2.58199
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	3.0482 mmol/L	Standard Deviation 7.55874
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	3.8889 mmol/L	Standard Deviation 2.66667
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.2159 mmol/L	Standard Deviation 0.25466
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium Corrected (Serum) Minimum Post Baseline Value	-0.4240 mmol/L	Standard Deviation 0.14415
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.4636 mmol/L	Standard Deviation 0.35631
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Maximum Post Baseline Value	4.8800 mmol/L	Standard Deviation 3.04171
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Bicarbonate (Serum) Minimum Post Baseline Value	-4.6800 mmol/L	Standard Deviation 1.73551
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-5.2222 mmol/L	Standard Deviation 3.49205
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.7778 mmol/L	Standard Deviation 0.40242
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	6.0000 mmol/L	Standard Deviation 8.06226
Part B - AML 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-0.9405 mmol/L	Standard Deviation 1.10505
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Minimum Post Baseline Value	-9.0000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Maximum Post Baseline Value	3.4410 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Glucose (Serum Fasting) Minimum Post Baseline Value	-0.7770 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Maximum Post Baseline Value	0.2000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Minimum Post Baseline Value	-8.0000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Chloride (Serum) Maximum Post Baseline Value	0.0000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Potassium (Serum) Minimum Post Baseline Value	-0.7000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Minimum Post Baseline Value	-0.1233 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0725 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Minimum Post Baseline Value	-0.3553 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	-0.0925 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Minimum Post Baseline Value	-12.0000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Sodium (Serum) Maximum Post Baseline Value	-1.0000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Magnesium (Serum) Maximum Post Baseline Value	0.1644 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	8.5680 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	0.0000 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Phosphate (Serum) Maximum Post Baseline Value	0.0646 mmol/L	—
Part B - MDS 3.0 mg	Change From Baseline by Laboratory Test - Chemistry Parameters 3	Carbon Dioxide (Plasma) Maximum Post Baseline Value	1.0000 mmol/L	—

Secondary

Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1

Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-7.6667 beats/min	Standard Deviation 4.24264
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	34.3333 beats/min	Standard Deviation 19.79899
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-7.3333 beats/min	Standard Deviation 3.29983
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	16.1667 beats/min	Standard Deviation 8.72098
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-9.5000 beats/min	Standard Deviation 1.64992
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	12.0000 beats/min	Standard Deviation 2.35702
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-12.1429 beats/min	Standard Deviation 6.43445
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	12.1429 beats/min	Standard Deviation 5.74088
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	14.4000 beats/min	Standard Deviation 8.57108
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-11.0667 beats/min	Standard Deviation 6.22106
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	7.0000 beats/min	Standard Deviation 9.02466
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-14.6667 beats/min	Standard Deviation 16.75642
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-11.4167 beats/min	Standard Deviation 10.22563
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	22.3333 beats/min	Standard Deviation 13.38324
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-17.6190 beats/min	Standard Deviation 12.6028
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	9.0952 beats/min	Standard Deviation 9.70627
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-19.7619 beats/min	Standard Deviation 10.39536
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	16.3810 beats/min	Standard Deviation 9.12349
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-12.6667 beats/min	Standard Deviation 7.66848
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	15.2222 beats/min	Standard Deviation 14.31491
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-18.6667 beats/min	Standard Deviation 5.84047
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	10.0000 beats/min	Standard Deviation 12.81059
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	24.2381 beats/min	Standard Deviation 14.62331
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-14.6190 beats/min	Standard Deviation 12.27981
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	12.9167 beats/min	Standard Deviation 8.59633
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-13.8333 beats/min	Standard Deviation 12.14463
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-3.5000 beats/min	Standard Deviation 8.24958
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	14.5000 beats/min	Standard Deviation 5.42115
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-13.1250 beats/min	Standard Deviation 11.7756
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	7.5000 beats/min	Standard Deviation 7.95024
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-15.8750 beats/min	Standard Deviation 7.08662
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	4.8750 beats/min	Standard Deviation 5.46253
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Minimum Post Baseline Value	-9.0000 beats/min	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1	ECG Mean Heart Rate Maximum Post Baseline Value	22.0000 beats/min	—

Secondary

Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2

Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-227.8333 msec	Standard Deviation 115.25841
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-26.6667 msec	Standard Deviation 18.85618
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-11.1667 msec	Standard Deviation 4.94975
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-23.3333 msec	Standard Deviation 15.55635
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	23.1667 msec	Standard Deviation 24.74874
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	79.1667 msec	Standard Deviation 37.47666
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	30.3333 msec	Standard Deviation 34.41253
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	15.8333 msec	Standard Deviation 2.12132
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-47.3333 msec	Standard Deviation 2.82843
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	15.1667 msec	Standard Deviation 13.43503
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-10.6667 msec	Standard Deviation 0.94281
Part A - 0.3 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	17.3333 msec	Standard Deviation 0.4714
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-17.6667 msec	Standard Deviation 2.82843
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	29.3333 msec	Standard Deviation 13.67073
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	11.8333 msec	Standard Deviation 3.53553
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-154.1667 msec	Standard Deviation 60.10408
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	25.8333 msec	Standard Deviation 6.83537
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	21.3333 msec	Standard Deviation 8.48528
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	95.8333 msec	Standard Deviation 33.23402
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-3.6667 msec	Standard Deviation 5.65685
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-13.6667 msec	Standard Deviation 4.71405
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	11.3333 msec	Standard Deviation 1.41421
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-43.1667 msec	Standard Deviation 10.1352
Part A - 0.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-23.1667 msec	Standard Deviation 0.70711
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-13.1667 msec	Standard Deviation 3.06413
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-18.1667 msec	Standard Deviation 2.59272
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-26.1667 msec	Standard Deviation 7.77817
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	25.3333 msec	Standard Deviation 14.61354
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-100.0000 msec	Standard Deviation 40.54079
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	31.0000 msec	Standard Deviation 27.34146
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	27.8333 msec	Standard Deviation 20.5061
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	101.5000 msec	Standard Deviation 11.07801
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-36.0000 msec	Standard Deviation 2.35702
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-24.8333 msec	Standard Deviation 2.59272
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	25.1667 msec	Standard Deviation 28.51997
Part A - 1.2 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	8.3333 msec	Standard Deviation 2.35702
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-6.9524 msec	Standard Deviation 5.68764
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-29.1667 msec	Standard Deviation 24.444
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	30.8571 msec	Standard Deviation 15.99983
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	126.6190 msec	Standard Deviation 77.45092
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-31.0000 msec	Standard Deviation 19.99074
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-18.3333 msec	Standard Deviation 9.18453
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	34.0952 msec	Standard Deviation 14.69784
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	21.1667 msec	Standard Deviation 16.32142
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-88.3810 msec	Standard Deviation 43.76047
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-37.9048 msec	Standard Deviation 23.49288
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	33.2619 msec	Standard Deviation 20.14711
Part A - 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	11.3333 msec	Standard Deviation 6.12826
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	11.8444 msec	Standard Deviation 9.61387
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-33.0222 msec	Standard Deviation 30.52672
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-120.3111 msec	Standard Deviation 73.42359
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-26.0000 msec	Standard Deviation 14.1163
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-25.9333 msec	Standard Deviation 17.71879
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	10.1333 msec	Standard Deviation 3.75182
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-35.9778 msec	Standard Deviation 24.63978
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	41.2889 msec	Standard Deviation 25.74844
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	40.2667 msec	Standard Deviation 20.09154
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	130.0889 msec	Standard Deviation 103.01028
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	37.0000 msec	Standard Deviation 23.07613
Part A - 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-10.3333 msec	Standard Deviation 5.60187
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-11.6667 msec	Standard Deviation 27.42464
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-11.4444 msec	Standard Deviation 2.14303
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	35.5556 msec	Standard Deviation 15.84064
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	31.0000 msec	Standard Deviation 33.88379
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	13.1111 msec	Standard Deviation 3.35548
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	10.8889 msec	Standard Deviation 15.25463
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	40.0000 msec	Standard Deviation 14.16961
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-21.7778 msec	Standard Deviation 23.04665
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-33.6667 msec	Standard Deviation 30.6884
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-90.3333 msec	Standard Deviation 130.08203
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-12.2222 msec	Standard Deviation 6.16742
Part A - 3.6 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	122.0000 msec	Standard Deviation 189.59694
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	35.1250 msec	Standard Deviation 22.78257
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-32.2917 msec	Standard Deviation 10.8488
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	9.3333 msec	Standard Deviation 8.49089
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	21.0952 msec	Standard Deviation 14.84203
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-35.9167 msec	Standard Deviation 12.32593
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	155.9167 msec	Standard Deviation 134.00577
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-16.9167 msec	Standard Deviation 14.64582
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-17.7619 msec	Standard Deviation 10.10815
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	35.3333 msec	Standard Deviation 29.2412
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-214.3333 msec	Standard Deviation 104.85455
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-44.8750 msec	Standard Deviation 22.7114
Part A - 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	46.3333 msec	Standard Deviation 47.27025
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	30.1905 msec	Standard Deviation 24.71156
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-87.4286 msec	Standard Deviation 76.34879
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-43.5714 msec	Standard Deviation 15.36315
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	214.8571 msec	Standard Deviation 139.93727
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	7.0000 msec	Standard Deviation 6.85025
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-32.8095 msec	Standard Deviation 19.6326
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-22.1111 msec	Standard Deviation 9.44144
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	26.5714 msec	Standard Deviation 12.68086
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	49.4762 msec	Standard Deviation 44.13316
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-30.0952 msec	Standard Deviation 26.46361
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-13.1429 msec	Standard Deviation 6.33876
Part A - 4.5 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	20.8889 msec	Standard Deviation 18.09809
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	245.8571 msec	Standard Deviation 205.30329
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-120.5714 msec	Standard Deviation 75.49263
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-14.9524 msec	Standard Deviation 14.86785
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	23.0476 msec	Standard Deviation 21.51866
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-5.9048 msec	Standard Deviation 3.62968
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	13.5238 msec	Standard Deviation 6.72711
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-36.4286 msec	Standard Deviation 21.44823
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	70.7143 msec	Standard Deviation 52.20559
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-23.2381 msec	Standard Deviation 21.81718
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	35.9048 msec	Standard Deviation 22.60999
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-24.1429 msec	Standard Deviation 17.22279
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	42.7143 msec	Standard Deviation 31.84594
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-124.4815 msec	Standard Deviation 110.59047
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-26.2593 msec	Standard Deviation 13.96004
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	30.8148 msec	Standard Deviation 20.01466
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	27.1481 msec	Standard Deviation 13.6678
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	7.2963 msec	Standard Deviation 4.94819
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-12.5926 msec	Standard Deviation 5.66612
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	35.7778 msec	Standard Deviation 19.04089
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-33.2963 msec	Standard Deviation 15.06047
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-36.8889 msec	Standard Deviation 29.53341
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	8.7407 msec	Standard Deviation 8.21884
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-37.8519 msec	Standard Deviation 13.50834
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	168.4074 msec	Standard Deviation 120.28609
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-56.2222 msec	Standard Deviation 66.17513
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-5.8889 msec	Standard Deviation 2.6943
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-8.5556 msec	Standard Deviation 7.01057
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	21.1111 msec	Standard Deviation 4.53791
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-15.7778 msec	Standard Deviation 18.67956
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-15.0000 msec	Standard Deviation 8.37324
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	189.7778 msec	Standard Deviation 60.6175
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-24.3333 msec	Standard Deviation 12.44097
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	37.3333 msec	Standard Deviation 20.52911
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	51.2222 msec	Standard Deviation 23.57101
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	12.7778 msec	Standard Deviation 1.83586
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	35.6667 msec	Standard Deviation 17.63834
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-28.9048 msec	Standard Deviation 11.3116
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-10.5714 msec	Standard Deviation 10.2699
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	28.6667 msec	Standard Deviation 14.31394
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	40.2381 msec	Standard Deviation 24.11985
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	25.3333 msec	Standard Deviation 14.2348
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-172.6667 msec	Standard Deviation 101.57519
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-28.2381 msec	Standard Deviation 15.88234
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	168.7619 msec	Standard Deviation 147.66074
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	18.0000 msec	Standard Deviation 17.54106
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	17.2857 msec	Standard Deviation 17.24919
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-19.5000 msec	Standard Deviation 15.86576
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-44.7619 msec	Standard Deviation 18.83526
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	11.6250 msec	Standard Deviation 7.4417
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-24.2917 msec	Standard Deviation 13.7095
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-27.7083 msec	Standard Deviation 25.60347
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-95.5833 msec	Standard Deviation 71.55434
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	41.2917 msec	Standard Deviation 26.23728
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	47.9167 msec	Standard Deviation 32.36388
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	42.2500 msec	Standard Deviation 23.41872
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-37.4583 msec	Standard Deviation 21.83047
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	21.8333 msec	Standard Deviation 17.58697
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-7.3750 msec	Standard Deviation 5.51603
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-29.5000 msec	Standard Deviation 23.42228
Part B - AML 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	151.7917 msec	Standard Deviation 121.02039
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	43.5000 msec	Standard Deviation 8.72098
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-30.0000 msec	Standard Deviation 20.27039
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-6.6667 msec	Standard Deviation 0
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	34.5000 msec	Standard Deviation 30.877
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	13.5000 msec	Standard Deviation 4.94975
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-2.6667 msec	Standard Deviation 2.35702
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-25.0000 msec	Standard Deviation 22.62742
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	57.8333 msec	Standard Deviation 13.90643
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	59.3333 msec	Standard Deviation 144.24978
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-7.5000 msec	Standard Deviation 5.42115
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-204.1667 msec	Standard Deviation 102.53048
Part B - MDS 3.6 mg + DEX	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	14.8333 msec	Standard Deviation 7.77817
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	136.5833 msec	Standard Deviation 98.81002
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-18.2083 msec	Standard Deviation 28.82125
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-62.1667 msec	Standard Deviation 91.12036
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	7.8750 msec	Standard Deviation 4.57369
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-18.8333 msec	Standard Deviation 21.34672
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	41.4167 msec	Standard Deviation 17.87767
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-13.7500 msec	Standard Deviation 7.04802
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	49.5417 msec	Standard Deviation 26.98144
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-22.0000 msec	Standard Deviation 5.94045
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-24.5000 msec	Standard Deviation 19.07213
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	41.5000 msec	Standard Deviation 23.81343
Part B - AML 2.4 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	7.6667 msec	Standard Deviation 11.36466
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	33.5417 msec	Standard Deviation 2.98641
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	193.0000 msec	Standard Deviation 72.50638
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-17.7083 msec	Standard Deviation 19.25059
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	36.7500 msec	Standard Deviation 6.69932
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	17.9583 msec	Standard Deviation 12.78446
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-12.1250 msec	Standard Deviation 15.84542
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-49.6250 msec	Standard Deviation 54.53539
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	57.0417 msec	Standard Deviation 20.0392
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-9.8333 msec	Standard Deviation 8.09468
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-13.3333 msec	Standard Deviation 17.30033
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-21.2917 msec	Standard Deviation 15.1505
Part B - AML 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	12.2917 msec	Standard Deviation 5.39676
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Minimum Post Baseline Value	-19.3333 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Minimum Post Baseline Value	-16.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Maximum Post Baseline Value	110.3333 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Maximum Post Baseline Value	29.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Minimum Post Baseline Value	-7.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcB Interval, Aggregate Maximum Post Baseline Value	27.6667 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QTcF Interval, Aggregate Minimum Post Baseline Value	-19.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	RR Interval, Aggregate Minimum Post Baseline Value	-179.6667 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QRS Duration, Aggregate Maximum Post Baseline Value	26.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Maximum Post Baseline Value	31.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	PR Interval, Aggregate Maximum Post Baseline Value	11.0000 msec	—
Part B - MDS 3.0 mg	Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2	QT Interval, Aggregate Minimum Post Baseline Value	-43.0000 msec	—

Secondary

Change From Baseline for Vital Signs by Test - Parameters 1

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-7.0 mmHg	Standard Deviation 7.07
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	23.0 mmHg	Standard Deviation 0
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	23.0 mmHg	Standard Deviation 0
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-18.5 mmHg	Standard Deviation 3.54
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	33.0 mmHg	Standard Deviation 0
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-2.0 mmHg	Standard Deviation 7.07
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-15.0 mmHg	Standard Deviation 2.83
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	33.0 mmHg	Standard Deviation 4.24
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-18.0 mmHg	Standard Deviation 19.8
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	12.5 mmHg	Standard Deviation 6.36
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	18.5 mmHg	Standard Deviation 7.78
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-19.5 mmHg	Standard Deviation 13.44
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	18.6 mmHg	Standard Deviation 20.86
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-16.7 mmHg	Standard Deviation 6.65
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-37.0 mmHg	Standard Deviation 16.73
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	16.6 mmHg	Standard Deviation 1.9
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-27.9 mmHg	Standard Deviation 14.65
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	22.1 mmHg	Standard Deviation 13.36
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	17.4 mmHg	Standard Deviation 13.29
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-16.8 mmHg	Standard Deviation 7.18
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	10.3 mmHg	Standard Deviation 2.08
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-22.7 mmHg	Standard Deviation 9.87
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-54.0 mmHg	Standard Deviation 16.64
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	9.3 mmHg	Standard Deviation 7.77
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	22.6 mmHg	Standard Deviation 9.96
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	29.5 mmHg	Standard Deviation 16.25
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-27.8 mmHg	Standard Deviation 13.58
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-17.8 mmHg	Standard Deviation 6.36
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	26.1 mmHg	Standard Deviation 10.57
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-35.1 mmHg	Standard Deviation 16.2
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	17.7 mmHg	Standard Deviation 8.26
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-17.3 mmHg	Standard Deviation 8.44
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	18.3 mmHg	Standard Deviation 9.43
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-29.1 mmHg	Standard Deviation 10.46
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	25.4 mmHg	Standard Deviation 11.25
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-19.1 mmHg	Standard Deviation 8.43
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-15.0 mmHg	Standard Deviation 12.87
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-23.0 mmHg	Standard Deviation 12.27
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	23.6 mmHg	Standard Deviation 9.7
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	30.8 mmHg	Standard Deviation 18.08
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-25.7 mmHg	Standard Deviation 11.55
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	15.0 mmHg	Standard Deviation 3.46
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	20.0 mmHg	Standard Deviation 8.54
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-36.7 mmHg	Standard Deviation 23.07
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-14.9 mmHg	Standard Deviation 10.79
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-17.1 mmHg	Standard Deviation 10.9
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	19.4 mmHg	Standard Deviation 13.72
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	29.0 mmHg	Standard Deviation 8.33
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-22.8 mmHg	Standard Deviation 12.79
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-16.6 mmHg	Standard Deviation 11.9
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	17.9 mmHg	Standard Deviation 8.37
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	25.3 mmHg	Standard Deviation 12.68
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	45.5 mmHg	Standard Deviation 23.33
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-13.0 mmHg	Standard Deviation 14.14
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	20.0 mmHg	Standard Deviation 9.9
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-10.0 mmHg	Standard Deviation 11.31
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	16.9 mmHg	Standard Deviation 11.54
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-17.2 mmHg	Standard Deviation 7.6
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	24.4 mmHg	Standard Deviation 9.5
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-27.3 mmHg	Standard Deviation 16.65
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	14.3 mmHg	Standard Deviation 16.01
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-29.1 mmHg	Standard Deviation 18.2
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-19.1 mmHg	Standard Deviation 11.47
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	27.3 mmHg	Standard Deviation 21.51
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Maximum Post Baseline Value	26.0 mmHg	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Maximum Post Baseline Value	26.0 mmHg	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Diastolic Blood Pressure Minimum Post Baseline Value	-10.0 mmHg	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 1	Systolic Blood Pressure Minimum Post Baseline Value	-31.0 mmHg	—

Secondary

Change From Baseline for Vital Signs by Test - Parameters 2

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-1.0 beats/min	Standard Deviation 1.41
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	29.0 beats/min	Standard Deviation 9.9
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	2.0 beats/min	Standard Deviation 2.83
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-15.5 beats/min	Standard Deviation 4.95
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	28.0 beats/min	Standard Deviation 8.49
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-3.0 beats/min	Standard Deviation 1.41
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-6.0 beats/min	Standard Deviation 5.66
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	3.0 beats/min	Standard Deviation 3
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.0 beats/min	Standard Deviation 0
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	4.0 beats/min	Standard Deviation 2.83
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	17.0 beats/min	Standard Deviation 18.38
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-21.5 beats/min	Standard Deviation 10.61
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	27.7 beats/min	Standard Deviation 24.98
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-1.0 beats/min	Standard Deviation 1.73
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-9.7 beats/min	Standard Deviation 13.41
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	2.9 beats/min	Standard Deviation 1.68
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-14.1 beats/min	Standard Deviation 10.85
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	32.0 beats/min	Standard Deviation 12.1
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	5.0 beats/min	Standard Deviation 5.15
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-1.9 beats/min	Standard Deviation 1.39
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	4.0 beats/min	Standard Deviation 2
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.3 beats/min	Standard Deviation 2.52
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-23.0 beats/min	Standard Deviation 12.12
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	14.0 beats/min	Standard Deviation 18.25
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	3.9 beats/min	Standard Deviation 2.64
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	38.9 beats/min	Standard Deviation 16.86
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-14.0 beats/min	Standard Deviation 8.47
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.4 beats/min	Standard Deviation 2.97
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	23.9 beats/min	Standard Deviation 12.33
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-14.7 beats/min	Standard Deviation 10.34
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	4.7 beats/min	Standard Deviation 3.82
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.4 beats/min	Standard Deviation 2.57
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	2.9 beats/min	Standard Deviation 1.07
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-25.1 beats/min	Standard Deviation 14.1
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	30.6 beats/min	Standard Deviation 16.53
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-4.9 beats/min	Standard Deviation 1.95
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-1.1 beats/min	Standard Deviation 1.36
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-18.4 beats/min	Standard Deviation 10.43
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	3.4 beats/min	Standard Deviation 3.36
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	26.3 beats/min	Standard Deviation 22.84
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-1.7 beats/min	Standard Deviation 2.08
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	3.7 beats/min	Standard Deviation 0.58
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	28.0 beats/min	Standard Deviation 19
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-22.7 beats/min	Standard Deviation 9.5
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.9 beats/min	Standard Deviation 2.79
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-24.7 beats/min	Standard Deviation 19.9
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	5.3 beats/min	Standard Deviation 4.11
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	22.1 beats/min	Standard Deviation 10.99
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-15.6 beats/min	Standard Deviation 9.59
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.8 beats/min	Standard Deviation 3.41
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	3.3 beats/min	Standard Deviation 3.58
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	29.4 beats/min	Standard Deviation 12.69
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	43.5 beats/min	Standard Deviation 13.44
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-3.5 beats/min	Standard Deviation 2.12
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	2.0 beats/min	Standard Deviation 0
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-11.0 beats/min	Standard Deviation 8.49
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	3.9 beats/min	Standard Deviation 6.95
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.4 beats/min	Standard Deviation 1.59
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	21.7 beats/min	Standard Deviation 21.82
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-21.9 beats/min	Standard Deviation 8.1
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	1.6 beats/min	Standard Deviation 1.42
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-11.8 beats/min	Standard Deviation 9.58
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-3.3 beats/min	Standard Deviation 2.65
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	25.3 beats/min	Standard Deviation 14.93
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Maximum Post Baseline Value	32.0 beats/min	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Maximum Post Baseline Value	2.0 beats/min	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Respiration Minimum Post Baseline Value	-2.0 beats/min	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 2	Pulse Minimum Post Baseline Value	-20.0 beats/min	—

Secondary

Change From Baseline for Vital Signs by Test - Parameters 3

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.15 Celsius	Standard Deviation 0.354
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.65 Celsius	Standard Deviation 0.778
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.45 Celsius	Standard Deviation 0.212
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.65 Celsius	Standard Deviation 0.212
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.25 Celsius	Standard Deviation 0.354
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.80 Celsius	Standard Deviation 0.566
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.50 Celsius	Standard Deviation 0.392
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.77 Celsius	Standard Deviation 0.591
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.93 Celsius	Standard Deviation 0.704
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.77 Celsius	Standard Deviation 0.443
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	-0.03 Celsius	Standard Deviation 0.513
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-1.47 Celsius	Standard Deviation 1.686
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.61 Celsius	Standard Deviation 0.34
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.86 Celsius	Standard Deviation 0.657
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.76 Celsius	Standard Deviation 0.395
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	1.67 Celsius	Standard Deviation 1.378
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-1.69 Celsius	Standard Deviation 0.83
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.73 Celsius	Standard Deviation 0.647
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-1.08 Celsius	Standard Deviation 0.499
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.39 Celsius	Standard Deviation 0.326
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.50 Celsius	Standard Deviation 0.3
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	1.40 Celsius	Standard Deviation 0.866
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.67 Celsius	Standard Deviation 0.468
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-1.16 Celsius	Standard Deviation 0.678
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.73 Celsius	Standard Deviation 0.865
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.99 Celsius	Standard Deviation 0.511
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.55 Celsius	Standard Deviation 0.354
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.25 Celsius	Standard Deviation 0.071
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.74 Celsius	Standard Deviation 0.456
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.49 Celsius	Standard Deviation 0.607
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-3.31 Celsius	Standard Deviation 6.473
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	6.97 Celsius	Standard Deviation 19.185
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Minimum Post Baseline Value	-0.60 Celsius	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 3	Temperature Maximum Post Baseline Value	0.90 Celsius	—

Secondary

Change From Baseline for Vital Signs by Test - Parameters 4

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-1.20 Kg	Standard Deviation 1.697
Part A - 0.3 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	4.00 Kg	Standard Deviation 2.404
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	0.70 Kg	Standard Deviation 0.424
Part A - 0.6 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-2.05 Kg	Standard Deviation 0.495
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	2.10 Kg	Standard Deviation 0.707
Part A - 1.2 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-4.40 Kg	Standard Deviation 6.223
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-4.27 Kg	Standard Deviation 3.41
Part A - 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	3.40 Kg	Standard Deviation 4.987
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	2.19 Kg	Standard Deviation 4.788
Part A - 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-4.51 Kg	Standard Deviation 2.254
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-3.13 Kg	Standard Deviation 2.928
Part A - 3.6 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	2.83 Kg	Standard Deviation 3.539
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	2.55 Kg	Standard Deviation 3.789
Part A - 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-5.38 Kg	Standard Deviation 5.135
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	2.13 Kg	Standard Deviation 2.833
Part A - 4.5 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-2.60 Kg	Standard Deviation 3.475
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-3.86 Kg	Standard Deviation 2.375
Part A - 3.6 mg (Days 1 - 7 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	3.89 Kg	Standard Deviation 3.074
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-3.40 Kg	Standard Deviation 4.31
Part A - 3.0 mg (Days 1- 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	0.54 Kg	Standard Deviation 1.415
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-3.57 Kg	Standard Deviation 1.358
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	1.70 Kg	Standard Deviation 1.947
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-5.84 Kg	Standard Deviation 1.786
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	0.94 Kg	Standard Deviation 2.028
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	1.27 Kg	Standard Deviation 3.364
Part B - AML 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-4.37 Kg	Standard Deviation 3.617
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	0.55 Kg	Standard Deviation 0.778
Part B - MDS 3.6 mg + DEX	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-8.55 Kg	Standard Deviation 5.303
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-2.44 Kg	Standard Deviation 2.993
Part B - AML 2.4 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	0.89 Kg	Standard Deviation 2.194
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	-4.84 Kg	Standard Deviation 3.91
Part B - AML 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	1.74 Kg	Standard Deviation 3.25
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Maximum Post Baseline Value	4.60 Kg	—
Part B - MDS 3.0 mg	Change From Baseline for Vital Signs by Test - Parameters 4	Weight Minimum Post Baseline Value	0.00 Kg	—

Secondary

Complete Remission Rate (CRR)

The complete remission rate (CRR) is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission \[CR\] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)). CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000/μL, thrombocytopenia \< 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts \<5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%, negative EMD.

Time frame: Up to approximately 88 months

Population: All treated participants with available CRR results

Arm	Measure	Value (NUMBER)
Part A - 3.0 mg	Complete Remission Rate (CRR)	6.7 Percent of participants
Part A - 3.6 mg	Complete Remission Rate (CRR)	33.3 Percent of participants
Part A - 3.6 mg + DEX	Complete Remission Rate (CRR)	25.0 Percent of participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Complete Remission Rate (CRR)	28.6 Percent of participants
Part A - 3.0 mg (Days 1- 10 of 28)	Complete Remission Rate (CRR)	22.2 Percent of participants
Part B - AML 3.6 mg + DEX	Complete Remission Rate (CRR)	12.5 Percent of participants
Part B - AML 3.0 mg	Complete Remission Rate (CRR)	11.1 Percent of participants

Secondary

Duration of Remission/Response (DOR)

DOR is defined as the time from first remission/response observed to the date of relapse, death or PD. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants with response

Arm	Measure	Value (MEDIAN)
Part A - 0.3 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 0.6 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 1.2 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 2.4 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 3.0 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 3.6 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 3.6 mg + DEX	Duration of Remission/Response (DOR)	1.32 Months
Part A - 4.5 mg	Duration of Remission/Response (DOR)	NA Months
Part A - 3.6 mg (Days 1 - 7 of 28)	Duration of Remission/Response (DOR)	NA Months
Part A - 3.0 mg (Days 1- 10 of 28)	Duration of Remission/Response (DOR)	NA Months
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Duration of Remission/Response (DOR)	NA Months
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Duration of Remission/Response (DOR)	NA Months
Part B - AML 3.6 mg + DEX	Duration of Remission/Response (DOR)	3.02 Months
Part B - MDS 3.6 mg + DEX	Duration of Remission/Response (DOR)	NA Months
Part B - AML 2.4 mg	Duration of Remission/Response (DOR)	NA Months
Part B - AML 3.0 mg	Duration of Remission/Response (DOR)	NA Months
Part B - MDS 3.0 mg	Duration of Remission/Response (DOR)	NA Months

Secondary

Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of participants with post-baseline grade increase or decrease from baseline. Grade 0=; Grade 1=; Grade 2=; Grade 3=; Grade 4=; Grade 5=; . Baseline = last value before start of treatment.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A - 0.3 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part A - 0.3 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 0.6 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part A - 0.6 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part A - 1.2 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part A - 1.2 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 2.4 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	2 Participants
Part A - 2.4 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part A - 3.0 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part A - 3.0 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	2 Participants
Part A - 3.6 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 3.6 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part A - 3.6 mg + DEX	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	2 Participants
Part A - 3.6 mg + DEX	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 4.5 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	3 Participants
Part A - 4.5 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	1 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	2 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	1 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	2 Participants
Part B - AML 3.6 mg + DEX	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part B - AML 3.6 mg + DEX	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	2 Participants
Part B - MDS 3.6 mg + DEX	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part B - MDS 3.6 mg + DEX	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants
Part B - AML 2.4 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	3 Participants
Part B - AML 2.4 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	2 Participants
Part B - AML 3.0 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part B - AML 3.0 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	2 Participants
Part B - MDS 3.0 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Increase	0 Participants
Part B - MDS 3.0 mg	Eastern Cooperative Oncology Group (ECOG) Performance Status	Post Baseline Grade Decrease	0 Participants

Secondary

Event-free Survival (EFS)

EFS is defined as the interval from the date of the first dose to an event including disease progression (PD), treatment failure, relapse, or death from any cause, whichever occurs first. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants

Arm	Measure	Value (MEDIAN)
Part A - 0.3 mg	Event-free Survival (EFS)	1.56 Months
Part A - 0.6 mg	Event-free Survival (EFS)	2.02 Months
Part A - 1.2 mg	Event-free Survival (EFS)	3.99 Months
Part A - 2.4 mg	Event-free Survival (EFS)	0.95 Months
Part A - 3.0 mg	Event-free Survival (EFS)	1.32 Months
Part A - 3.6 mg	Event-free Survival (EFS)	1.02 Months
Part A - 3.6 mg + DEX	Event-free Survival (EFS)	1.45 Months
Part A - 4.5 mg	Event-free Survival (EFS)	1.32 Months
Part A - 3.6 mg (Days 1 - 7 of 28)	Event-free Survival (EFS)	3.39 Months
Part A - 3.0 mg (Days 1- 10 of 28)	Event-free Survival (EFS)	1.07 Months
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Event-free Survival (EFS)	1.94 Months
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Event-free Survival (EFS)	1.51 Months
Part B - AML 3.6 mg + DEX	Event-free Survival (EFS)	0.97 Months
Part B - MDS 3.6 mg + DEX	Event-free Survival (EFS)	7.81 Months
Part B - AML 2.4 mg	Event-free Survival (EFS)	0.99 Months
Part B - AML 3.0 mg	Event-free Survival (EFS)	0.99 Months
Part B - MDS 3.0 mg	Event-free Survival (EFS)	1.84 Months

Secondary

Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline

Left Ventricular Ejection Fraction (LVEF) percent change from baseline. Baseline = last value before start of treatment. Minimum Post Baseline Value=lowest value of the measured parameter is recorded after the baseline measurement. Maximum Post Baseline Value=highest value of the measured parameter is recorded after the baseline measurement.

Time frame: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Arm	Measure	Group	Value (MEAN)	Dispersion
Part A - 0.3 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-8.1 Percent change	Standard Deviation 15.88
Part A - 0.3 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-8.1 Percent change	Standard Deviation 15.88
Part A - 0.6 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	15.2 Percent change	Standard Deviation 0.88
Part A - 0.6 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	15.2 Percent change	Standard Deviation 0.88
Part A - 1.2 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-3.5 Percent change	—
Part A - 1.2 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-3.5 Percent change	—
Part A - 2.4 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-9.1 Percent change	Standard Deviation 18.42
Part A - 2.4 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-9.9 Percent change	Standard Deviation 17.61
Part A - 3.0 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	1.8 Percent change	Standard Deviation 7.37
Part A - 3.0 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	1.8 Percent change	Standard Deviation 7.37
Part A - 3.6 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-1.6 Percent change	—
Part A - 3.6 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-9.8 Percent change	—
Part A - 3.6 mg + DEX	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	3.2 Percent change	Standard Deviation 9.86
Part A - 3.6 mg + DEX	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	3.2 Percent change	Standard Deviation 9.86
Part A - 4.5 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-3.7 Percent change	Standard Deviation 8
Part A - 4.5 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-3.7 Percent change	Standard Deviation 8
Part A - 3.6 mg (Days 1 - 7 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	1.8 Percent change	Standard Deviation 10.63
Part A - 3.6 mg (Days 1 - 7 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	1.8 Percent change	Standard Deviation 10.63
Part A - 3.0 mg (Days 1- 10 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	0.1 Percent change	Standard Deviation 17.54
Part A - 3.0 mg (Days 1- 10 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	0.1 Percent change	Standard Deviation 17.54
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	2.3 Percent change	Standard Deviation 3.21
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	3.1 Percent change	Standard Deviation 2.11
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	8.7 Percent change	Standard Deviation 10.19
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	8.7 Percent change	Standard Deviation 10.19
Part B - AML 3.6 mg + DEX	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-8.3 Percent change	Standard Deviation 11.79
Part B - AML 3.6 mg + DEX	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-8.3 Percent change	Standard Deviation 11.79
Part B - MDS 3.6 mg + DEX	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	17.5 Percent change	Standard Deviation 26.66
Part B - MDS 3.6 mg + DEX	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	17.5 Percent change	Standard Deviation 26.66
Part B - AML 2.4 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	5.2 Percent change	Standard Deviation 26.32
Part B - AML 2.4 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	5.2 Percent change	Standard Deviation 26.32
Part B - AML 3.0 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	-3.3 Percent change	Standard Deviation 8.62
Part B - AML 3.0 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	-3.3 Percent change	Standard Deviation 8.62
Part B - MDS 3.0 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Maximum Post Baseline Value	1.5 Percent change	—
Part B - MDS 3.0 mg	Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline	Minimum Post Baseline Value	1.0 Percent change	—

Secondary

Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data

Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part A - 0.3 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	17.21 ng/mL	Geometric Coefficient of Variation 47.65
Part A - 0.3 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	21.15 ng/mL	Geometric Coefficient of Variation 1.67
Part A - 0.6 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	47.19 ng/mL	Geometric Coefficient of Variation 55.57
Part A - 0.6 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	59.61 ng/mL	Geometric Coefficient of Variation 19.21
Part A - 1.2 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	71.30 ng/mL	Geometric Coefficient of Variation 0.6
Part A - 1.2 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	33.31 ng/mL	Geometric Coefficient of Variation 90.26
Part A - 2.4 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	143.42 ng/mL	Geometric Coefficient of Variation 356.59
Part A - 2.4 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	120.48 ng/mL	Geometric Coefficient of Variation 42.56
Part A - 3.0 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	115.40 ng/mL	Geometric Coefficient of Variation 93.25
Part A - 3.0 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	106.23 ng/mL	Geometric Coefficient of Variation 88.56
Part A - 3.6 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	82.40 ng/mL	—
Part A - 3.6 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	94.31 ng/mL	Geometric Coefficient of Variation 75.89
Part A - 3.6 mg + DEX	Maximum Observed Plasma Concentration (Cmax)	C1D1	90.77 ng/mL	Geometric Coefficient of Variation 46.38
Part A - 3.6 mg + DEX	Maximum Observed Plasma Concentration (Cmax)	C1D5	147.16 ng/mL	Geometric Coefficient of Variation 95.76
Part A - 4.5 mg	Maximum Observed Plasma Concentration (Cmax)	C1D5	107.68 ng/mL	Geometric Coefficient of Variation 17.5
Part A - 4.5 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	103.00 ng/mL	Geometric Coefficient of Variation 26.22
Part A - 3.6 mg (Days 1 - 7 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D1	122.02 ng/mL	Geometric Coefficient of Variation 52.39
Part A - 3.6 mg (Days 1 - 7 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D7	156.65 ng/mL	Geometric Coefficient of Variation 48.38
Part A - 3.0 mg (Days 1- 10 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D1	116.60 ng/mL	Geometric Coefficient of Variation 276.56
Part A - 3.0 mg (Days 1- 10 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D10	107.89 ng/mL	Geometric Coefficient of Variation 28.36
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D1	129.53 ng/mL	Geometric Coefficient of Variation 61.68
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D8	215.18 ng/mL	Geometric Coefficient of Variation 17.41
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D8	111.52 ng/mL	Geometric Coefficient of Variation 29.72
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Maximum Observed Plasma Concentration (Cmax)	C1D1	96.78 ng/mL	Geometric Coefficient of Variation 42.25
Part B - AML 3.6 mg + DEX	Maximum Observed Plasma Concentration (Cmax)	C1D1	179.97 ng/mL	Geometric Coefficient of Variation 211.3
Part B - MDS 3.6 mg + DEX	Maximum Observed Plasma Concentration (Cmax)	C1D1	499.18 ng/mL	Geometric Coefficient of Variation 2403.37
Part B - AML 2.4 mg	Maximum Observed Plasma Concentration (Cmax)	C1D7	47.33 ng/mL	Geometric Coefficient of Variation 75.83
Part B - AML 2.4 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	50.99 ng/mL	Geometric Coefficient of Variation 59.25
Part B - AML 3.0 mg	Maximum Observed Plasma Concentration (Cmax)	C1D7	99.57 ng/mL	Geometric Coefficient of Variation 79.67
Part B - AML 3.0 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	73.94 ng/mL	Geometric Coefficient of Variation 72.41
Part B - MDS 3.0 mg	Maximum Observed Plasma Concentration (Cmax)	C1D7	108.00 ng/mL	—
Part B - MDS 3.0 mg	Maximum Observed Plasma Concentration (Cmax)	C1D1	24.50 ng/mL	—

Secondary

Maximum Tolerated Dose (MTD) of CC-90009

The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable participants experiencing a DLT in Cycle 1 during dose escalation (part A).

Time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)

Population: All treated participants in dose escalation (Part A)

Arm	Measure	Value (NUMBER)
Part A - 0.3 mg	Maximum Tolerated Dose (MTD) of CC-90009	3.6 mg

Secondary

Non-Tolerated Dose (NTD) of CC-90009

The NTD is defined as a dose level at which 2 or more of up to 6 evaluable participants in any dose cohort experience a DLT in Cycle 1 during dose escalation (Part A)

Time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)

Population: All treated participants in dose escalation (Part A)

Arm	Measure	Value (NUMBER)
Part A - 0.3 mg	Non-Tolerated Dose (NTD) of CC-90009	4.5 mg

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin on or after the start of study drug through 28 days after the last dose of study drug or serious AEs that are suspected of being related to study drug.

Time frame: From first dose until 28 days post last dose (Up to 25 months)

Population: All treated participants

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A - 0.3 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	0 Participants
Part A - 0.3 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	0 Participants
Part A - 0.3 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	2 Participants
Part A - 0.3 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	2 Participants
Part A - 0.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	0 Participants
Part A - 0.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	0 Participants
Part A - 0.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	2 Participants
Part A - 0.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	0 Participants
Part A - 1.2 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	1 Participants
Part A - 1.2 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	2 Participants
Part A - 1.2 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	0 Participants
Part A - 1.2 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	2 Participants
Part A - 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	1 Participants
Part A - 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	7 Participants
Part A - 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	6 Participants
Part A - 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	6 Participants
Part A - 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	6 Participants
Part A - 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	13 Participants
Part A - 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	15 Participants
Part A - 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	15 Participants
Part A - 3.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	2 Participants
Part A - 3.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	3 Participants
Part A - 3.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	3 Participants
Part A - 3.6 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	3 Participants
Part A - 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	8 Participants
Part A - 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	8 Participants
Part A - 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	7 Participants
Part A - 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	4 Participants
Part A - 4.5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	6 Participants
Part A - 4.5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	7 Participants
Part A - 4.5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	7 Participants
Part A - 4.5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	7 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	3 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	7 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	7 Participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	7 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	9 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	9 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	4 Participants
Part A - 3.0 mg (Days 1- 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	6 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	1 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	3 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	3 Participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	3 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	7 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	7 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	1 Participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	6 Participants
Part B - AML 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	3 Participants
Part B - AML 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	8 Participants
Part B - AML 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	8 Participants
Part B - AML 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	8 Participants
Part B - MDS 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	2 Participants
Part B - MDS 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	2 Participants
Part B - MDS 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	1 Participants
Part B - MDS 3.6 mg + DEX	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	1 Participants
Part B - AML 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	7 Participants
Part B - AML 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	9 Participants
Part B - AML 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	9 Participants
Part B - AML 2.4 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	3 Participants
Part B - AML 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	7 Participants
Part B - AML 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	8 Participants
Part B - AML 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	9 Participants
Part B - AML 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	4 Participants
Part B - MDS 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE	0 Participants
Part B - MDS 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAE related to CC-90009	0 Participants
Part B - MDS 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE related to CC-90009	1 Participants
Part B - MDS 3.0 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAE	1 Participants

Secondary

Objective Response Rate (ORR)

Objectve response is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission \[CR\] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)) or Morphologic Leukemia - Free State or partial remission. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000/μL, thrombocytopenia \< 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts \<5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants

Arm	Measure	Value (NUMBER)
Part A - 0.3 mg	Objective Response Rate (ORR)	0 Percent of participants
Part A - 0.6 mg	Objective Response Rate (ORR)	0 Percent of participants
Part A - 1.2 mg	Objective Response Rate (ORR)	0 Percent of participants
Part A - 2.4 mg	Objective Response Rate (ORR)	0 Percent of participants
Part A - 3.0 mg	Objective Response Rate (ORR)	6.7 Percent of participants
Part A - 3.6 mg	Objective Response Rate (ORR)	33.3 Percent of participants
Part A - 3.6 mg + DEX	Objective Response Rate (ORR)	25.0 Percent of participants
Part A - 4.5 mg	Objective Response Rate (ORR)	0 Percent of participants
Part A - 3.6 mg (Days 1 - 7 of 28)	Objective Response Rate (ORR)	57.1 Percent of participants
Part A - 3.0 mg (Days 1- 10 of 28)	Objective Response Rate (ORR)	33.3 Percent of participants
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Objective Response Rate (ORR)	0 Percent of participants
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Objective Response Rate (ORR)	0 Percent of participants
Part B - AML 3.6 mg + DEX	Objective Response Rate (ORR)	25.0 Percent of participants
Part B - MDS 3.6 mg + DEX	Objective Response Rate (ORR)	0 Percent of participants
Part B - AML 2.4 mg	Objective Response Rate (ORR)	0 Percent of participants
Part B - AML 3.0 mg	Objective Response Rate (ORR)	11.1 Percent of participants
Part B - MDS 3.0 mg	Objective Response Rate (ORR)	0 Percent of participants

Secondary

Overall Survival (OS)

OS is defined as the time from the date of the first dose to the date of death from any cause.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants

Arm	Measure	Value (MEDIAN)
Part A - 0.3 mg	Overall Survival (OS)	4.93 Months
Part A - 0.6 mg	Overall Survival (OS)	8.27 Months
Part A - 1.2 mg	Overall Survival (OS)	8.02 Months
Part A - 2.4 mg	Overall Survival (OS)	2.79 Months
Part A - 3.0 mg	Overall Survival (OS)	1.91 Months
Part A - 3.6 mg	Overall Survival (OS)	8.28 Months
Part A - 3.6 mg + DEX	Overall Survival (OS)	3.25 Months
Part A - 4.5 mg	Overall Survival (OS)	1.68 Months
Part A - 3.6 mg (Days 1 - 7 of 28)	Overall Survival (OS)	3.39 Months
Part A - 3.0 mg (Days 1- 10 of 28)	Overall Survival (OS)	4.70 Months
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Overall Survival (OS)	3.72 Months
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Overall Survival (OS)	4.18 Months
Part B - AML 3.6 mg + DEX	Overall Survival (OS)	1.28 Months
Part B - MDS 3.6 mg + DEX	Overall Survival (OS)	7.81 Months
Part B - AML 2.4 mg	Overall Survival (OS)	2.43 Months
Part B - AML 3.0 mg	Overall Survival (OS)	2.30 Months
Part B - MDS 3.0 mg	Overall Survival (OS)	NA Months

Secondary

Progression-free Survival (PFS)

PFS is defined as the time from the date of the first dose to the date of first relapse after CR/CRi (for AML)/relapse after CR/PR(for MDS), or PD, or death resulting from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000 μL, thrombocytopenia \< 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants

Arm	Measure	Value (MEDIAN)
Part A - 0.3 mg	Progression-free Survival (PFS)	1.56 Months
Part A - 0.6 mg	Progression-free Survival (PFS)	2.10 Months
Part A - 1.2 mg	Progression-free Survival (PFS)	NA Months
Part A - 2.4 mg	Progression-free Survival (PFS)	1.74 Months
Part A - 3.0 mg	Progression-free Survival (PFS)	1.35 Months
Part A - 3.6 mg	Progression-free Survival (PFS)	1.02 Months
Part A - 3.6 mg + DEX	Progression-free Survival (PFS)	1.45 Months
Part A - 4.5 mg	Progression-free Survival (PFS)	1.50 Months
Part A - 3.6 mg (Days 1 - 7 of 28)	Progression-free Survival (PFS)	2.60 Months
Part A - 3.0 mg (Days 1- 10 of 28)	Progression-free Survival (PFS)	1.07 Months
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Progression-free Survival (PFS)	1.94 Months
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Progression-free Survival (PFS)	2.33 Months
Part B - AML 3.6 mg + DEX	Progression-free Survival (PFS)	1.07 Months
Part B - MDS 3.6 mg + DEX	Progression-free Survival (PFS)	7.81 Months
Part B - AML 2.4 mg	Progression-free Survival (PFS)	0.90 Months
Part B - AML 3.0 mg	Progression-free Survival (PFS)	2.30 Months
Part B - MDS 3.0 mg	Progression-free Survival (PFS)	1.84 Months

Secondary

Relapse-free Survival (RFS)

RFS is defined only for participants who achieved CR or CRi (for AML) / CR or PR (for MDS) and is measured as the interval from the date of first CR or CRi (for AML) / CR or PR (for MDS) to the date of relapse or death from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000 μL, thrombocytopenia \< 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants

Arm	Measure	Value (MEDIAN)
Part A - 0.3 mg	Relapse-free Survival (RFS)	NA Months
Part A - 0.6 mg	Relapse-free Survival (RFS)	NA Months
Part A - 1.2 mg	Relapse-free Survival (RFS)	NA Months
Part A - 2.4 mg	Relapse-free Survival (RFS)	NA Months
Part A - 3.0 mg	Relapse-free Survival (RFS)	NA Months
Part A - 3.6 mg	Relapse-free Survival (RFS)	NA Months
Part A - 3.6 mg + DEX	Relapse-free Survival (RFS)	10.83 Months
Part A - 4.5 mg	Relapse-free Survival (RFS)	NA Months
Part A - 3.6 mg (Days 1 - 7 of 28)	Relapse-free Survival (RFS)	2.40 Months
Part A - 3.0 mg (Days 1- 10 of 28)	Relapse-free Survival (RFS)	NA Months
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Relapse-free Survival (RFS)	NA Months
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Relapse-free Survival (RFS)	NA Months
Part B - AML 3.6 mg + DEX	Relapse-free Survival (RFS)	3.02 Months
Part B - MDS 3.6 mg + DEX	Relapse-free Survival (RFS)	NA Months
Part B - AML 2.4 mg	Relapse-free Survival (RFS)	NA Months
Part B - AML 3.0 mg	Relapse-free Survival (RFS)	NA Months
Part B - MDS 3.0 mg	Relapse-free Survival (RFS)	NA Months

Secondary

Renal Clearance (CLr)

Renal clearance of CC-90009 (CLr)

Time frame: Cycle 1 Day 1(C1D1). 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Part A - 3.0 mg	Renal Clearance (CLr)	0.63900 L/h	Geometric Coefficient of Variation 200.50356
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Renal Clearance (CLr)	0.61571 L/h	Geometric Coefficient of Variation 219.79379
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Renal Clearance (CLr)	1.10066 L/h	Geometric Coefficient of Variation 38.74255
Part B - MDS 3.6 mg + DEX	Renal Clearance (CLr)	40.973 L/h	Geometric Coefficient of Variation 129.68
Part B - AML 2.4 mg	Renal Clearance (CLr)	77.996 L/h	Geometric Coefficient of Variation 37.418
Part B - AML 3.0 mg	Renal Clearance (CLr)	86.419 L/h	Geometric Coefficient of Variation 99.105
Part B - MDS 3.0 mg	Renal Clearance (CLr)	104.000 L/h	—

Secondary

Terminal Phase Elimination Half-life (T1/2)

Terminal phase elimination half-life calculated as \[(ln 2)/λz\], where λz is the apparent terminal rate constant. t1/2 will only be calculated when a reliable estimate for λz can be obtained.

Time frame: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Group	Value (MEDIAN)
Part A - 0.3 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	3.783 hour
Part A - 0.6 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	7.717 hour
Part A - 1.2 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	7.295 hour
Part A - 2.4 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	5.991 hour
Part A - 3.0 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.317 hour
Part A - 3.6 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.864 hour
Part A - 3.6 mg + DEX	Terminal Phase Elimination Half-life (T1/2)	C1D1	4.001 hour
Part A - 4.5 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	8.378 hour
Part A - 3.6 mg (Days 1 - 7 of 28)	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.584 hour
Part A - 3.0 mg (Days 1- 10 of 28)	Terminal Phase Elimination Half-life (T1/2)	C1D1	3.739 hour
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Terminal Phase Elimination Half-life (T1/2)	C1D1	4.649 hour
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.795 hour
Part B - AML 3.6 mg + DEX	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.246 hour
Part B - MDS 3.6 mg + DEX	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.844 hour
Part B - AML 2.4 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	6.432 hour
Part B - AML 3.0 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	4.800 hour
Part B - MDS 3.0 mg	Terminal Phase Elimination Half-life (T1/2)	C1D1	7.737 hour

Secondary

Time to Acute Myeloid Leukemia (AML) Transformation

Time to acute AML transformation in part B Myelodysplastic Syndromes (MDS) participants only. Based on Kaplan-Meier Estimates.

Time frame: Up to approximately 88 months

Population: All treated participants in part B - MDS only as pre-specified

Arm	Measure	Value (MEDIAN)
Part A - 0.3 mg	Time to Acute Myeloid Leukemia (AML) Transformation	4.88 Months

Secondary

Time to Peak Plasma Concentration (Tmax)

Time to peak plasma concentration, obtained directly from the observed concentration versus time data.

Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Group	Value (MEDIAN)
Part A - 0.3 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	0.050 hour
Part A - 0.3 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.050 hour
Part A - 0.6 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	0.058 hour
Part A - 0.6 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.058 hour
Part A - 1.2 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.042 hour
Part A - 1.2 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	0.158 hour
Part A - 2.4 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.667 hour
Part A - 2.4 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	0.783 hour
Part A - 3.0 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.617 hour
Part A - 3.0 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	0.550 hour
Part A - 3.6 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	1.483 hour
Part A - 3.6 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.250 hour
Part A - 3.6 mg + DEX	Time to Peak Plasma Concentration (Tmax)	C1D1	0.350 hour
Part A - 3.6 mg + DEX	Time to Peak Plasma Concentration (Tmax)	C1D5	0.383 hour
Part A - 4.5 mg	Time to Peak Plasma Concentration (Tmax)	C1D5	0.750 hour
Part A - 4.5 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.767 hour
Part A - 3.6 mg (Days 1 - 7 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D1	0.750 hour
Part A - 3.6 mg (Days 1 - 7 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D7	0.583 hour
Part A - 3.0 mg (Days 1- 10 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D1	0.750 hour
Part A - 3.0 mg (Days 1- 10 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D10	0.800 hour
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D1	0.750 hour
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D8	0.750 hour
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D1	0.783 hour
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Time to Peak Plasma Concentration (Tmax)	C1D8	0.733 hour
Part B - AML 3.6 mg + DEX	Time to Peak Plasma Concentration (Tmax)	C1D1	0.767 hour
Part B - MDS 3.6 mg + DEX	Time to Peak Plasma Concentration (Tmax)	C1D1	0.783 hour
Part B - AML 2.4 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.783 hour
Part B - AML 2.4 mg	Time to Peak Plasma Concentration (Tmax)	C1D7	1.067 hour
Part B - AML 3.0 mg	Time to Peak Plasma Concentration (Tmax)	C1D7	0.775 hour
Part B - AML 3.0 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	0.800 hour
Part B - MDS 3.0 mg	Time to Peak Plasma Concentration (Tmax)	C1D1	1.083 hour
Part B - MDS 3.0 mg	Time to Peak Plasma Concentration (Tmax)	C1D7	0.667 hour

Secondary

Time to Remission/Response (TTR)

TTR is defined as the time between the date of first dose and the earliest date any remission/response (any complete remissions or partial remissions or better) is observed. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; CRi=residual neutropenia \< 1,000 μL, thrombocytopenia \< 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts \<5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts \<5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. Based on Kaplan-Meier Estimates.

Time frame: Up to approximately 25 months after the last dose

Population: All treated participants with available TTR results

Arm	Measure	Value (MEDIAN)
Part A - 3.0 mg	Time to Remission/Response (TTR)	0.85 Months
Part A - 3.6 mg	Time to Remission/Response (TTR)	2.01 Months
Part A - 3.6 mg + DEX	Time to Remission/Response (TTR)	1.00 Months
Part A - 3.6 mg (Days 1 - 7 of 28)	Time to Remission/Response (TTR)	1.12 Months
Part A - 3.0 mg (Days 1- 10 of 28)	Time to Remission/Response (TTR)	1.02 Months
Part B - AML 3.6 mg + DEX	Time to Remission/Response (TTR)	1.55 Months
Part B - AML 3.0 mg	Time to Remission/Response (TTR)	0.95 Months

Secondary

Total Body Clearance (CL)

Total plasma clearance after IV administration, calculated as \[Dose/ AUC(INF)\] following single administration, and \[Dose/ AUC(0-24)\] at steady state.

Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part A - 0.3 mg	Total Body Clearance (CL)	C1D1	12.684 L/h	Geometric Coefficient of Variation 38.525
Part A - 0.3 mg	Total Body Clearance (CL)	C1D5	11.134 L/h	Geometric Coefficient of Variation 35.442
Part A - 0.6 mg	Total Body Clearance (CL)	C1D5	4.238 L/h	Geometric Coefficient of Variation 99.224
Part A - 0.6 mg	Total Body Clearance (CL)	C1D1	4.868 L/h	Geometric Coefficient of Variation 75.331
Part A - 1.2 mg	Total Body Clearance (CL)	C1D1	8.796 L/h	Geometric Coefficient of Variation 143.853
Part A - 1.2 mg	Total Body Clearance (CL)	C1D5	8.423 L/h	Geometric Coefficient of Variation 149.082
Part A - 2.4 mg	Total Body Clearance (CL)	C1D1	6.882 L/h	Geometric Coefficient of Variation 74.11
Part A - 2.4 mg	Total Body Clearance (CL)	C1D5	3.120 L/h	Geometric Coefficient of Variation 25.689
Part A - 3.0 mg	Total Body Clearance (CL)	C1D5	5.594 L/h	Geometric Coefficient of Variation 39.561
Part A - 3.0 mg	Total Body Clearance (CL)	C1D1	7.352 L/h	Geometric Coefficient of Variation 43.454
Part A - 3.6 mg	Total Body Clearance (CL)	C1D5	2.650 L/h	—
Part A - 3.6 mg	Total Body Clearance (CL)	C1D1	6.140 L/h	Geometric Coefficient of Variation 125.199
Part A - 3.6 mg + DEX	Total Body Clearance (CL)	C1D1	11.105 L/h	Geometric Coefficient of Variation 24.102
Part A - 3.6 mg + DEX	Total Body Clearance (CL)	C1D5	5.772 L/h	Geometric Coefficient of Variation 55.283
Part A - 4.5 mg	Total Body Clearance (CL)	C1D5	6.721 L/h	Geometric Coefficient of Variation 23.895
Part A - 4.5 mg	Total Body Clearance (CL)	C1D1	5.932 L/h	Geometric Coefficient of Variation 24.699
Part A - 3.6 mg (Days 1 - 7 of 28)	Total Body Clearance (CL)	C1D1	5.418 L/h	Geometric Coefficient of Variation 69.589
Part A - 3.6 mg (Days 1 - 7 of 28)	Total Body Clearance (CL)	C1D7	3.751 L/h	Geometric Coefficient of Variation 80.086
Part A - 3.0 mg (Days 1- 10 of 28)	Total Body Clearance (CL)	C1D1	7.551 L/h	Geometric Coefficient of Variation 94.257
Part A - 3.0 mg (Days 1- 10 of 28)	Total Body Clearance (CL)	C1D10	3.857 L/h	Geometric Coefficient of Variation 14.571
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Total Body Clearance (CL)	C1D1	9.618 L/h	Geometric Coefficient of Variation 42.482
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Total Body Clearance (CL)	C1D8	7.098 L/h	Geometric Coefficient of Variation 40.903
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Total Body Clearance (CL)	C1D8	5.553 L/h	Geometric Coefficient of Variation 35.415
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Total Body Clearance (CL)	C1D1	6.828 L/h	Geometric Coefficient of Variation 77.163
Part B - AML 3.6 mg + DEX	Total Body Clearance (CL)	C1D1	3.809 L/h	Geometric Coefficient of Variation 71.852
Part B - MDS 3.6 mg + DEX	Total Body Clearance (CL)	C1D1	4.359 L/h	Geometric Coefficient of Variation 265.439
Part B - AML 2.4 mg	Total Body Clearance (CL)	C1D7	5.910 L/h	Geometric Coefficient of Variation 44.624
Part B - AML 2.4 mg	Total Body Clearance (CL)	C1D1	9.817 L/h	Geometric Coefficient of Variation 73.556
Part B - AML 3.0 mg	Total Body Clearance (CL)	C1D7	6.615 L/h	Geometric Coefficient of Variation 57.381
Part B - AML 3.0 mg	Total Body Clearance (CL)	C1D1	11.494 L/h	Geometric Coefficient of Variation 105.754
Part B - MDS 3.0 mg	Total Body Clearance (CL)	C1D7	7.060 L/h	—
Part B - MDS 3.0 mg	Total Body Clearance (CL)	C1D1	9.350 L/h	—

Secondary

Volume of Distribution (Vz)

Volume of distribution calculated at first dose only. Calculated as \[Vz = Dose/ AUC(INF) \* λz for Day 1\].

Time frame: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Part A - 0.3 mg	Volume of Distribution (Vz)	C1D1	65.74 L	Geometric Coefficient of Variation 8.29
Part A - 0.6 mg	Volume of Distribution (Vz)	C1D1	53.38 L	Geometric Coefficient of Variation 45.41
Part A - 1.2 mg	Volume of Distribution (Vz)	C1D1	79.87 L	Geometric Coefficient of Variation 27.7
Part A - 2.4 mg	Volume of Distribution (Vz)	C1D1	64.51 L	Geometric Coefficient of Variation 82.15
Part A - 3.0 mg	Volume of Distribution (Vz)	C1D1	68.28 L	Geometric Coefficient of Variation 32.16
Part A - 3.6 mg	Volume of Distribution (Vz)	C1D1	58.48 L	Geometric Coefficient of Variation 62.34
Part A - 3.6 mg + DEX	Volume of Distribution (Vz)	C1D1	65.80 L	Geometric Coefficient of Variation 20.59
Part A - 4.5 mg	Volume of Distribution (Vz)	C1D1	70.30 L	Geometric Coefficient of Variation 28.14
Part A - 3.6 mg (Days 1 - 7 of 28)	Volume of Distribution (Vz)	C1D1	46.58 L	Geometric Coefficient of Variation 41.72
Part A - 3.0 mg (Days 1- 10 of 28)	Volume of Distribution (Vz)	C1D1	55.03 L	Geometric Coefficient of Variation 73.6
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)	Volume of Distribution (Vz)	C1D1	66.95 L	Geometric Coefficient of Variation 55.61
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)	Volume of Distribution (Vz)	C1D1	60.12 L	Geometric Coefficient of Variation 41.69
Part B - AML 3.6 mg + DEX	Volume of Distribution (Vz)	C1D1	33.559 L	Geometric Coefficient of Variation 70.261
Part B - MDS 3.6 mg + DEX	Volume of Distribution (Vz)	C1D1	40.973 L	Geometric Coefficient of Variation 129.68
Part B - AML 2.4 mg	Volume of Distribution (Vz)	C1D1	77.996 L	Geometric Coefficient of Variation 37.418
Part B - AML 3.0 mg	Volume of Distribution (Vz)	C1D1	86.419 L	Geometric Coefficient of Variation 99.105
Part B - MDS 3.0 mg	Volume of Distribution (Vz)	C1D1	104.000 L	—

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With Dose Limiting Toxicity (DLTs)

Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)

Change From Baseline by Laboratory Test - Chemistry Parameters 1

Change From Baseline by Laboratory Test - Chemistry Parameters 2

Change From Baseline by Laboratory Test - Chemistry Parameters 3

Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1

Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2

Change From Baseline for Vital Signs by Test - Parameters 1

Change From Baseline for Vital Signs by Test - Parameters 2

Change From Baseline for Vital Signs by Test - Parameters 3

Change From Baseline for Vital Signs by Test - Parameters 4

Complete Remission Rate (CRR)

Duration of Remission/Response (DOR)

Eastern Cooperative Oncology Group (ECOG) Performance Status

Event-free Survival (EFS)

Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline

Maximum Observed Plasma Concentration (Cmax)

Maximum Tolerated Dose (MTD) of CC-90009

Non-Tolerated Dose (NTD) of CC-90009

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Objective Response Rate (ORR)

Overall Survival (OS)

Progression-free Survival (PFS)

Relapse-free Survival (RFS)

Renal Clearance (CLr)

Terminal Phase Elimination Half-life (T1/2)

Time to Acute Myeloid Leukemia (AML) Transformation

Time to Peak Plasma Concentration (Tmax)

Time to Remission/Response (TTR)

Total Body Clearance (CL)

Volume of Distribution (Vz)