Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT01687400

Recruitment Status : Completed

First Posted : September 18, 2012

Results First Posted : October 2, 2018

Last Update Posted : October 2, 2018

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Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Leukemia, Myeloid, Acute Myelodysplastic Syndromes
Intervention	Drug: decitabine
Enrollment	114

Participant Flow

Recruitment Details	The study opened to participant enrollment on 02/12/2013 and closed to participant enrollment on 06/19/2017.
Pre-assignment Details


Arm/Group Title	Decitabine
Arm/Group Description	Patients receive decitabine IV over...
Arm/Group Description	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started	114
Completed	114
Not Completed	0

Baseline Characteristics

Arm/Group Title		Decitabine
Arm/Group Description		Patients receive decitabine IV over...
Arm/Group Description		Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants		114
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	114 participants
		73 (31 to 88)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	114 participants
	Female	48 42.1%
	Male	66 57.9%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	114 participants
	Hispanic or Latino	1 0.9%
	Not Hispanic or Latino	90 78.9%
	Unknown or Not Reported	23 20.2%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	114 participants
	American Indian or Alaska Native	0 0.0%
	Asian	2 1.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	6 5.3%
	White	105 92.1%
	More than one race	0 0.0%
	Unknown or Not Reported	1 0.9%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	114 participants
United States		114

Outcome Measures

1.Primary Outcome


Title	Correlation of Patient Specific Mutations With Overall Response Rate
Description	-Best response after 4 treatment cycles as assessed according to Inter...
Description	-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate --Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)
Time Frame	4 months (4 treatment cycles)

Outcome Measure Data

Analysis Population Description

-Some participants were not evaluable for this outcome measure due to sample collection quality issues and if they had repeat bone marrow biopsies and could be evaluated for responses.


Arm/Group Title		Decitabine (Participants With Response of CR/CRi/mCR/PR)	Decitabine (Participants With Response of SD/PD)
Arm/Group Description:		Patients receive decitabine IV over...	Patients receive decitabine IV over...
Arm/Group Description:		Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed		64	22
Measure Type: Count of Participants Unit of Measure: Participants
TP53	Number Analyzed	64 participants	17 participants
TP53		26 40.6%	3 17.6%
ASXL1	Number Analyzed	64 participants	17 participants
ASXL1		9 14.1%	2 11.8%
SRSF2	Number Analyzed	64 participants	17 participants
SRSF2		7 10.9%	5 29.4%
IDH2	Number Analyzed	64 participants	17 participants
IDH2		6 9.4%	5 29.4%
DNMT3A	Number Analyzed	64 participants	17 participants
DNMT3A		8 12.5%	5 29.4%
SF3B1	Number Analyzed	64 participants	17 participants
SF3B1		7 10.9%	0 0.0%
RUNX1	Number Analyzed	45 participants	15 participants
RUNX1		5 11.1%	3 20.0%
TET2	Number Analyzed	45 participants	15 participants
TET2		4 8.9%	3 20.0%
IDH1	Number Analyzed	64 participants	17 participants
IDH1		2 3.1%	3 17.6%
NPM1	Number Analyzed	45 participants	15 participants
NPM1		4 8.9%	1 6.7%
NRAS	Number Analyzed	45 participants	15 participants
NRAS		3 6.7%	3 20.0%
U2AF1	Number Analyzed	64 participants	17 participants
U2AF1		4 6.3%	1 5.9%
MY05B	Number Analyzed	45 participants	15 participants
MY05B		3 6.7%	2 13.3%
WT1	Number Analyzed	45 participants	15 participants
WT1		5 11.1%	1 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #1 is for the genetic mutation TP53.
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.035
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #2 is for ASXL1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.72
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #3 is for SRSF2 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.28
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #4 is for IDH2 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.14
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #5 is for DNMT3A genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #6 is for SF3B1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.183
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #7 is for RUNX1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.42
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #8 is for TET2 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.36
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #9 is for IDH1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #10 is for NPM1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #11 is for NRAS genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.17
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	-Statistical analysis #12 is for U2AF1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #13 is for MY05B genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Decitabine (Participants With Response of CR/CRi/mCR/PR), Decitabine (Participants With Response of SD/PD)
	Comments	Statistical analysis #14 is for WT1 genetic mutation
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	1
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

2.Secondary Outcome


Title	Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)
Description	The overall response rate (CR/CRi/mCR/PR) and complete response rate (...
Description	The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.
Time Frame	4 months (4 treatment cycles)

Outcome Measure Data

Analysis Population Description

-Participants were evaluable for this outcome measure if they completed at least one cycle of treatment and the cycle 1 day 28 bone marrow biopsy to assess response


Arm/Group Title	Decitabine
Arm/Group Description:	Patients receive decitabine IV over...
Arm/Group Description:	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	98
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
Overall response rate (CR, CRi/mCR/PR)	74.42 (65.20 to 83.64)
Complete response rate (CR, CRi, mCR)	63.95 (53.81 to 74.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Decitabine
	Comments	-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)

Method of Estimation	Estimation Parameter	Overall Response Rate-for current study
	Estimated Value	0.744
	Confidence Interval	(2-Sided) 95% 0.652 to 0.836
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Decitabine
	Comments	-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)

Method of Estimation	Estimation Parameter	Complete response rate-for current study
	Estimated Value	0.640
	Confidence Interval	(2-Sided) 95% 0.538 to 0.741
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Rate of Mutation Clearance During Treatment
Description	Samples collected at baseline and after 10, 28 and 56 days of therapy;...
Description	Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .
Time Frame	Up to Day 56

Outcome Measure Data

Analysis Population Description

-The first 39 cases with adequate samples were serially evaluated with enhanced exome sequencing. The investigators evaluated 15 additional cases using gene panel sequencing.


Arm/Group Title		Decitabine
Arm/Group Description:		Patients receive decitabine IV over...
Arm/Group Description:		Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed		54
Mean (Standard Deviation) Unit of Measure: proportion of variant alleles per day
TP53	Number Analyzed	16 participants
TP53		-0.781 (0.4423)
SRSF2	Number Analyzed	10 participants
SRSF2		-0.2214 (0.2705)
DNMT3A	Number Analyzed	10 participants
DNMT3A		-0.2122 (0.2817)
IDH2	Number Analyzed	9 participants
IDH2		-0.08344 (0.2841)
RUNX1	Number Analyzed	8 participants
RUNX1		-0.2641 (0.6536)
TET2	Number Analyzed	9 participants
TET2		-0.07478 (0.3164)
ASXL1	Number Analyzed	7 participants
ASXL1		-0.3898 (0.3791)
IDH1	Number Analyzed	5 participants
IDH1		-0.1103 (0.196)
NRAS	Number Analyzed	5 participants
NRAS		0.04544 (0.2554)
SF3B1	Number Analyzed	5 participants
SF3B1		-0.719 (0.3481)

4.Secondary Outcome


Title	Peripheral Blood Decitabine Plasma Levels
Description	...
Description	To determine whether steady state serum concentrations of decitabine correlated with responses Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria
Time Frame	Day 4

Outcome Measure Data

Analysis Population Description

The first 45 participants enrolled with adequate samples were analyzed using GC-MS quantification of serum decitabine levels. Sufficient funds were lacking to complete the analysis of additional participants and all participants with data analyzed are reported.


Arm/Group Title		Decitabine
Arm/Group Description:		Patients receive decitabine IV over...
Arm/Group Description:		Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed		45
Mean (Standard Deviation) Unit of Measure: ng/ml
CR	Number Analyzed	3 participants
CR		140.5 (53.41)
CRi	Number Analyzed	16 participants
CRi		117.2 (54.6)
PR	Number Analyzed	5 participants
PR		67.71 (56.18)
SD	Number Analyzed	12 participants
SD		145 (73.06)
PD	Number Analyzed	3 participants
PD		298.5 (213.3)
NA	Number Analyzed	6 participants
NA		99.64 (58.4)

5.Secondary Outcome


Title	Change in Bone Marrow Methylcytosine
Description	-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosin...
Description	-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10
Time Frame	Baseline and Day 10

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Decitabine (CR/CRi/mCR)	Decitabine (PR/SD/PD)
Arm/Group Description:	Patients receive decitabine IV over...	Patients receive decitabine IV over...
Arm/Group Description:	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed	14	11
Mean (Standard Deviation) Unit of Measure: proportion of methylcytosine
Day 0	0.53 (0)	0.5374 (0)
Day 10	0.4416 (0.0247)	0.4639 (0.035)

Adverse Events

Time Frame	-Adverse events were collected from the start of treatment until 30 days following the last day of study treatment (average 5 months) -All deaths were collected from enrollment through study completion date.
Adverse Event Reporting Description	Grades 1-5 adverse events will be recorded for the first 50 enrolled participants. Grades 3-5 will be recorded for the remainder of enrolled participants (n=64).

Arm/Group Title	Decitabine (First 50 Enrolled Patients)	Decitabine (Remainder of Enrolled Patients n=64)
Arm/Group Description	Patients receive decitabine IV over...	Patients receive decitabine IV over...
Arm/Group Description	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.	Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
	Decitabine (First 50 Enrolled Patients)	Decitabine (Remainder of Enrolled Patients n=64)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	38/50 (76.00%)	43/64 (67.19%)
Serious Adverse Events Serious Adverse Events
	Decitabine (First 50 Enrolled Patients)	Decitabine (Remainder of Enrolled Patients n=64)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	42/50 (84.00%)	47/64 (73.44%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	23/50 (46.00%)	30/64 (46.88%)
Cardiac disorders
Atrial fibrillation ^† 1	1/50 (2.00%)	1/64 (1.56%)
Atrial flutter ^† 1	0/50 (0.00%)	1/64 (1.56%)
Cardiac arrest ^† 1	1/50 (2.00%)	0/64 (0.00%)
Heart failure ^† 1	0/50 (0.00%)	1/64 (1.56%)
NSTEMI ^† 1	0/50 (0.00%)	1/64 (1.56%)
Pericardial effusion ^† 1	1/50 (2.00%)	0/64 (0.00%)
STEMI ^† 1	0/50 (0.00%)	2/64 (3.13%)
Eye disorders
Central retinal venous occlusion ^† 1	1/50 (2.00%)	0/64 (0.00%)
Gastrointestinal disorders
Colitis ^† 1	0/50 (0.00%)	3/64 (4.69%)
Constipation ^† 1	0/50 (0.00%)	2/64 (3.13%)
Diarrhea ^† 1	1/50 (2.00%)	2/64 (3.13%)
Hematemesis ^† 1	1/50 (2.00%)	1/64 (1.56%)
Ileus ^† 1	1/50 (2.00%)	0/64 (0.00%)
Mucositis - oral ^† 1	0/50 (0.00%)	1/64 (1.56%)
General disorders
Edema ^† 1	1/50 (2.00%)	0/64 (0.00%)
Failure to thrive ^† 1	0/50 (0.00%)	1/64 (1.56%)
Fever ^† 1	1/50 (2.00%)	0/64 (0.00%)
Infusion related reaction ^† 1	2/50 (4.00%)	1/64 (1.56%)
Malaise ^† 1	1/50 (2.00%)	0/64 (0.00%)
Pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Progressive disease/death ^† 1	5/50 (10.00%)	2/64 (3.13%)
Infections and infestations
Bacteremia - Coagulase negative staphylococcus ^† 1	0/50 (0.00%)	2/64 (3.13%)
Bacteremia - E. coli ^† 1	0/50 (0.00%)	2/64 (3.13%)
Bacteremia - ESBL E. coli ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bacteremia - Enterococcus faecium ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bacteremia - Klebsiella pneumoniae ^† 1	0/50 (0.00%)	1/64 (1.56%)
Bacteremia - Micrococcus ^† 1	0/50 (0.00%)	1/64 (1.56%)
Bacteremia - Staphylococcus capitis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Bacteremia - Staphylococcus epidermis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Bacteremia - Staphylococcus infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Bacteremia - Streptococcus ^† 1	0/50 (0.00%)	2/64 (3.13%)
Bacteremia - Streptococcus mitis ^† 1	0/50 (0.00%)	4/64 (6.25%)
Bacteremia - VRE ^† 1	0/50 (0.00%)	1/64 (1.56%)
Bacteremia - gram negative ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bone infection - Osteomyelitis ^† 1	1/50 (2.00%)	0/64 (0.00%)
C. difficile ^† 1	0/50 (0.00%)	2/64 (3.13%)
Catheter related infection ^† 1	4/50 (8.00%)	2/64 (3.13%)
Cellulitis infection/pneumonia infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Dental infection ^† 1	1/50 (2.00%)	0/64 (0.00%)
Diverticulitis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Diverticulitis infection ^† 1	0/50 (0.00%)	2/64 (3.13%)
Endovascular infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Fusarium fungemia infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Iletitis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Lung infection ^† 1	4/50 (8.00%)	14/64 (21.88%)
Parainfluenza infection ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sepsis ^† 1	3/50 (6.00%)	7/64 (10.94%)
Septic arthritis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sinusitis ^† 1	0/50 (0.00%)	2/64 (3.13%)
Skin infection ^† 1	3/50 (6.00%)	5/64 (7.81%)
Submandicular sialadenitis infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Tooth infection ^† 1	2/50 (4.00%)	0/64 (0.00%)
Upper respiratory infection ^† 1	0/50 (0.00%)	2/64 (3.13%)
Upper respiratory infection - parainfluenza ^† 1	1/50 (2.00%)	0/64 (0.00%)
Urinary tract infection ^† 1	1/50 (2.00%)	3/64 (4.69%)
Bacteremia - Streptococcus mitis/oralis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Injury, poisoning and procedural complications
Fall ^† 1	2/50 (4.00%)	1/64 (1.56%)
Investigations
White blood cell count decreased ^† 1	0/50 (0.00%)	1/64 (1.56%)
Metabolism and nutrition disorders
Hyponatremia ^† 1	1/50 (2.00%)	0/64 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/50 (0.00%)	1/64 (1.56%)
Back pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Myositis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Nervous system disorders
Intracranial hemorrhage ^† 1	0/50 (0.00%)	1/64 (1.56%)
Stroke ^† 1	1/50 (2.00%)	1/64 (1.56%)
Psychiatric disorders
Confusion ^† 1	1/50 (2.00%)	0/64 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	2/50 (4.00%)	0/64 (0.00%)
Hematuria ^† 1	1/50 (2.00%)	1/64 (1.56%)
Respiratory, thoracic and mediastinal disorders
Acute hypoxemic respiratory failure ^† 1	0/50 (0.00%)	1/64 (1.56%)
Dyspnea ^† 1	1/50 (2.00%)	0/64 (0.00%)
Epistaxis ^† 1	0/50 (0.00%)	5/64 (7.81%)
Pleural effusion ^† 1	1/50 (2.00%)	1/64 (1.56%)
Pulmonary embolism ^† 1	0/50 (0.00%)	2/64 (3.13%)
Respiratory failure ^† 1	1/50 (2.00%)	1/64 (1.56%)
Respiratory syncytial virus ^† 1	0/50 (0.00%)	1/64 (1.56%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^† 1	1/50 (2.00%)	2/64 (3.13%)
Sweet's syndrome ^† 1	1/50 (2.00%)	1/64 (1.56%)
Vascular disorders
Hematoma ^† 1	0/50 (0.00%)	1/64 (1.56%)
Hypotension ^† 1	1/50 (2.00%)	1/64 (1.56%)
Thromboembolic event ^† 1	3/50 (6.00%)	2/64 (3.13%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Decitabine (First 50 Enrolled Patients)	Decitabine (Remainder of Enrolled Patients n=64)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/50 (100.00%)	64/64 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	14/50 (28.00%)	22/64 (34.38%)
Febrile neutropenia ^† 1	16/50 (32.00%)	13/64 (20.31%)
Lymph node pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Submandibular lymphadenopathy ^† 1	1/50 (2.00%)	0/64 (0.00%)
Cardiac disorders
Atrial fibrillation ^† 1	4/50 (8.00%)	4/64 (6.25%)
Atrial flutter ^† 1	1/50 (2.00%)	0/64 (0.00%)
Chest pain ^† 1	2/50 (4.00%)	0/64 (0.00%)
Electrocardiogram QT corrected interval prolonged ^† 1	1/50 (2.00%)	0/64 (0.00%)
Heart failure ^† 1	1/50 (2.00%)	2/64 (3.13%)
Left ventricular systolic dysfunction ^† 1	1/50 (2.00%)	1/64 (1.56%)
Myocardial infarction ^† 1	2/50 (4.00%)	1/64 (1.56%)
Palpitations ^† 1	2/50 (4.00%)	0/64 (0.00%)
Pericardial effusion ^† 1	4/50 (8.00%)	0/64 (0.00%)
Pericardial tamponade ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sinus bradycardia ^† 1	5/50 (10.00%)	0/64 (0.00%)
Sinus tachycardia ^† 1	18/50 (36.00%)	0/64 (0.00%)
Supraventricular tachycardia ^† 1	2/50 (4.00%)	1/64 (1.56%)
Ventricular ectopy ^† 1	0/50 (0.00%)	1/64 (1.56%)
Ear and labyrinth disorders
Ear congestion ^† 1	2/50 (4.00%)	0/64 (0.00%)
Ear pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Hearing impaired ^† 1	1/50 (2.00%)	0/64 (0.00%)
Eye disorders
Blurred vision ^† 1	4/50 (8.00%)	0/64 (0.00%)
Conjunctivitis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Diplopia ^† 1	1/50 (2.00%)	0/64 (0.00%)
Dry eye ^† 1	1/50 (2.00%)	0/64 (0.00%)
Floaters ^† 1	1/50 (2.00%)	0/64 (0.00%)
Photophobia ^† 1	1/50 (2.00%)	0/64 (0.00%)
Vision changes unspecified ^† 1	1/50 (2.00%)	0/64 (0.00%)
Vision loss partial (temporary) ^† 1	1/50 (2.00%)	0/64 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	12/50 (24.00%)	0/64 (0.00%)
Anal mucositis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bloating ^† 1	1/50 (2.00%)	0/64 (0.00%)
Burping ^† 1	1/50 (2.00%)	0/64 (0.00%)
Constipation ^† 1	25/50 (50.00%)	0/64 (0.00%)
Dental caries ^† 1	1/50 (2.00%)	0/64 (0.00%)
Diarrhea ^† 1	26/50 (52.00%)	0/64 (0.00%)
Diverticulitis ^† 1	0/50 (0.00%)	2/64 (3.13%)
Diverticulosis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Dry mouth ^† 1	2/50 (4.00%)	0/64 (0.00%)
Dyspepsia ^† 1	3/50 (6.00%)	0/64 (0.00%)
Dysphagia ^† 1	5/50 (10.00%)	1/64 (1.56%)
Esophagitis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Fecal incontinence ^† 1	4/50 (8.00%)	0/64 (0.00%)
Gastric hemorrhage ^† 1	1/50 (2.00%)	0/64 (0.00%)
Gastrointestinal pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Hiatal hernia ^† 1	3/50 (6.00%)	0/64 (0.00%)
Hypothermia ^† 1	1/50 (2.00%)	0/64 (0.00%)
Ileus ^† 1	1/50 (2.00%)	0/64 (0.00%)
Lower gastrointestinal hemorrhage ^† 1	1/50 (2.00%)	0/64 (0.00%)
Mucositis - oral ^† 1	33/50 (66.00%)	2/64 (3.13%)
Nausea ^† 1	28/50 (56.00%)	1/64 (1.56%)
Oral hemorrhage ^† 1	3/50 (6.00%)	1/64 (1.56%)
Oral pain ^† 1	5/50 (10.00%)	0/64 (0.00%)
Pancreatic cyst ^† 1	1/50 (2.00%)	0/64 (0.00%)
Pancreatitis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Small bowel obstruction ^† 1	1/50 (2.00%)	0/64 (0.00%)
Toothache ^† 1	3/50 (6.00%)	1/64 (1.56%)
Typhlitis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Vomiting ^† 1	19/50 (38.00%)	0/64 (0.00%)
General disorders
Chills ^† 1	31/50 (62.00%)	0/64 (0.00%)
Edema face ^† 1	2/50 (4.00%)	0/64 (0.00%)
Edema limbs ^† 1	31/50 (62.00%)	2/64 (3.13%)
Facial pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Fatigue ^† 1	26/50 (52.00%)	7/64 (10.94%)
Fever ^† 1	2/50 (4.00%)	0/64 (0.00%)
Gait disturbance ^† 1	1/50 (2.00%)	0/64 (0.00%)
Infusion related reaction ^† 1	9/50 (18.00%)	1/64 (1.56%)
Irritability ^† 1	1/50 (2.00%)	0/64 (0.00%)
Localized edema ^† 1	1/50 (2.00%)	0/64 (0.00%)
Malaise ^† 1	3/50 (6.00%)	0/64 (0.00%)
Non-cardiac chest pain ^† 1	7/50 (14.00%)	0/64 (0.00%)
Pain ^† 1	15/50 (30.00%)	1/64 (1.56%)
Immune system disorders
Allergic reaction ^† 1	5/50 (10.00%)	0/64 (0.00%)
Infections and infestations
Bacteremia (Gram negative) ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bacteremia - Escherichia coli/Pseudomonus aeruginosa ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bacteremia - Myobacterium abscessus ^† 1	1/50 (2.00%)	0/64 (0.00%)
Bacteremia - Pseudomonas aeruginosa ^† 1	1/50 (2.00%)	1/64 (1.56%)
Bacteremia - Staphylococcus epidermidis ^† 1	2/50 (4.00%)	1/64 (1.56%)
Bacteremia - Streptococcus mitis ^† 1	0/50 (0.00%)	3/64 (4.69%)
Bacteremia - Streptococcus mitis/Coagulase negative staphylococcus ^† 1	0/50 (0.00%)	1/64 (1.56%)
C. difficile ^† 1	2/50 (4.00%)	0/64 (0.00%)
Candidal intertrigo (genital) ^† 1	1/50 (2.00%)	0/64 (0.00%)
Catheter related infection ^† 1	4/50 (8.00%)	6/64 (9.38%)
Fungal abscess brain ^† 1	0/50 (0.00%)	1/64 (1.56%)
Fungal infection - spleen and liver ^† 1	0/50 (0.00%)	1/64 (1.56%)
Gastroenteritis (viral) ^† 1	2/50 (4.00%)	0/64 (0.00%)
Gum infection ^† 1	1/50 (2.00%)	0/64 (0.00%)
HSV infection ^† 1	1/50 (2.00%)	0/64 (0.00%)
Infection mouth lesion ^† 1	1/50 (2.00%)	0/64 (0.00%)
Infective myositis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Joint infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Lung infection ^† 1	17/50 (34.00%)	10/64 (15.63%)
Oral buccosal infection ^† 1	1/50 (2.00%)	0/64 (0.00%)
Oral thrush ^† 1	13/50 (26.00%)	0/64 (0.00%)
Otitis externa ^† 1	1/50 (2.00%)	0/64 (0.00%)
Perineal folliculitis ^† 1	0/50 (0.00%)	1/64 (1.56%)
Preseptal cellulitis ^† 1	0/50 (0.00%)	2/64 (3.13%)
Salivary gland infection ^† 1	0/50 (0.00%)	1/64 (1.56%)
Sepsis ^† 1	9/50 (18.00%)	1/64 (1.56%)
Septic arthritis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sinusitis ^† 1	4/50 (8.00%)	1/64 (1.56%)
Skin infection ^† 1	17/50 (34.00%)	1/64 (1.56%)
Tooth infection ^† 1	4/50 (8.00%)	0/64 (0.00%)
Upper respiratory infection ^† 1	4/50 (8.00%)	0/64 (0.00%)
Urinary tract infection ^† 1	2/50 (4.00%)	0/64 (0.00%)
Vaginal infection ^† 1	1/50 (2.00%)	0/64 (0.00%)
Injury, poisoning and procedural complications
Bruising ^† 1	21/50 (42.00%)	0/64 (0.00%)
Burn ^† 1	1/50 (2.00%)	0/64 (0.00%)
Fall ^† 1	9/50 (18.00%)	2/64 (3.13%)
Fracture ^† 1	2/50 (4.00%)	0/64 (0.00%)
Hemorrhage from bronchoscopy ^† 1	0/50 (0.00%)	1/64 (1.56%)
Hip pain following bone marrow biopsy ^† 1	0/50 (0.00%)	1/64 (1.56%)
Postoperative hemmorhage ^† 1	3/50 (6.00%)	0/64 (0.00%)
Skin abrasion ^† 1	2/50 (4.00%)	0/64 (0.00%)
Investigations
Activated partial thromboplastin time prolonged ^† 1	19/50 (38.00%)	5/64 (7.81%)
Alanine aminotransferase increased ^† 1	30/50 (60.00%)	2/64 (3.13%)
Alkaline phosphatase increased ^† 1	19/50 (38.00%)	1/64 (1.56%)
Aspartate aminotransferase increased ^† 1	26/50 (52.00%)	2/64 (3.13%)
Blood bilirubin increased ^† 1	19/50 (38.00%)	0/64 (0.00%)
Cardiac troponin I increased ^† 1	3/50 (6.00%)	0/64 (0.00%)
Cardiac troponin T increased ^† 1	1/50 (2.00%)	0/64 (0.00%)
Creatinine increased ^† 1	8/50 (16.00%)	0/64 (0.00%)
Electrocardiogram QT corrected interval prolonged ^† 1	6/50 (12.00%)	3/64 (4.69%)
INR increased ^† 1	28/50 (56.00%)	0/64 (0.00%)
Lymphocyte count decreased ^† 1	44/50 (88.00%)	45/64 (70.31%)
Lymphocyte count increased ^† 1	0/50 (0.00%)	1/64 (1.56%)
Neutrophil count decreased ^† 1	20/50 (40.00%)	38/64 (59.38%)
Platelet count decreased ^† 1	27/50 (54.00%)	47/64 (73.44%)
Weight gain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Weight loss ^† 1	21/50 (42.00%)	0/64 (0.00%)
White blood cell decreased ^† 1	43/50 (86.00%)	54/64 (84.38%)
Metabolism and nutrition disorders
Acidosis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Anorexia ^† 1	22/50 (44.00%)	2/64 (3.13%)
Dehydration ^† 1	15/50 (30.00%)	6/64 (9.38%)
Hypercalcemia ^† 1	3/50 (6.00%)	0/64 (0.00%)
Hyperglycemia ^† 1	8/50 (16.00%)	13/64 (20.31%)
Hyperkalemia ^† 1	9/50 (18.00%)	0/64 (0.00%)
Hypermagnesemia ^† 1	5/50 (10.00%)	1/64 (1.56%)
Hypernatremia ^† 1	7/50 (14.00%)	1/64 (1.56%)
Hyperuricemia ^† 1	1/50 (2.00%)	1/64 (1.56%)
Hypoalbuminemia ^† 1	39/50 (78.00%)	2/64 (3.13%)
Hypocalcemia ^† 1	29/50 (58.00%)	1/64 (1.56%)
Hypokalemia ^† 1	29/50 (58.00%)	14/64 (21.88%)
Hypomagnesemia ^† 1	7/50 (14.00%)	0/64 (0.00%)
Hyponatremia ^† 1	37/50 (74.00%)	12/64 (18.75%)
Hypophosphatemia ^† 1	28/50 (56.00%)	13/64 (20.31%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	10/50 (20.00%)	0/64 (0.00%)
Back pain ^† 1	10/50 (20.00%)	1/64 (1.56%)
Bone pain ^† 1	2/50 (4.00%)	0/64 (0.00%)
Bone spur ^† 1	1/50 (2.00%)	0/64 (0.00%)
Degenerative disc disease ^† 1	1/50 (2.00%)	0/64 (0.00%)
Flank pain ^† 1	0/50 (0.00%)	1/64 (1.56%)
Generalized muscle weakness ^† 1	24/50 (48.00%)	6/64 (9.38%)
Hand cramps ^† 1	2/50 (4.00%)	0/64 (0.00%)
Joint effusion ^† 1	0/50 (0.00%)	1/64 (1.56%)
Muscle cramps ^† 1	1/50 (2.00%)	0/64 (0.00%)
Myalgia ^† 1	3/50 (6.00%)	0/64 (0.00%)
Neck pain ^† 1	2/50 (4.00%)	0/64 (0.00%)
Pain in extremity ^† 1	10/50 (20.00%)	1/64 (1.56%)
Nervous system disorders
Burning sensation ^† 1	1/50 (2.00%)	0/64 (0.00%)
Cognitive impairment acute worsening from baseline ^† 1	0/50 (0.00%)	1/64 (1.56%)
Dizziness ^† 1	15/50 (30.00%)	1/64 (1.56%)
Dysarthria ^† 1	1/50 (2.00%)	0/64 (0.00%)
Dysgeusia ^† 1	3/50 (6.00%)	0/64 (0.00%)
Encephalopathy ^† 1	3/50 (6.00%)	1/64 (1.56%)
Facial muscle weakness ^† 1	1/50 (2.00%)	0/64 (0.00%)
Headache ^† 1	16/50 (32.00%)	0/64 (0.00%)
Lethargy ^† 1	13/50 (26.00%)	0/64 (0.00%)
Neuralgia ^† 1	1/50 (2.00%)	0/64 (0.00%)
Paresthesia ^† 1	2/50 (4.00%)	0/64 (0.00%)
Peripheral motor neuropathy ^† 1	0/50 (0.00%)	1/64 (1.56%)
Peripheral sensory neuropathy ^† 1	3/50 (6.00%)	0/64 (0.00%)
Presyncope ^† 1	1/50 (2.00%)	0/64 (0.00%)
Restless leg syndrome ^† 1	2/50 (4.00%)	0/64 (0.00%)
Seizure ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sinus pain ^† 1	2/50 (4.00%)	0/64 (0.00%)
Somnolence ^† 1	7/50 (14.00%)	0/64 (0.00%)
Stroke ^† 1	1/50 (2.00%)	1/64 (1.56%)
Syncope ^† 1	0/50 (0.00%)	2/64 (3.13%)
Tremor ^† 1	2/50 (4.00%)	0/64 (0.00%)
Psychiatric disorders
Agitation ^† 1	2/50 (4.00%)	0/64 (0.00%)
Altered mental status ^† 1	1/50 (2.00%)	0/64 (0.00%)
Anxiety ^† 1	3/50 (6.00%)	0/64 (0.00%)
Confusion ^† 1	17/50 (34.00%)	1/64 (1.56%)
Delirium ^† 1	2/50 (4.00%)	0/64 (0.00%)
Depression ^† 1	5/50 (10.00%)	0/64 (0.00%)
Hallucinations ^† 1	3/50 (6.00%)	0/64 (0.00%)
Insomnia ^† 1	9/50 (18.00%)	0/64 (0.00%)
Restlessness ^† 1	1/50 (2.00%)	0/64 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	7/50 (14.00%)	0/64 (0.00%)
Acute renal failure ^† 1	0/50 (0.00%)	2/64 (3.13%)
Bladder spasm ^† 1	1/50 (2.00%)	0/64 (0.00%)
Hematuria ^† 1	28/50 (56.00%)	0/64 (0.00%)
Proteinuria ^† 1	22/50 (44.00%)	0/64 (0.00%)
Urinary frequency ^† 1	6/50 (12.00%)	0/64 (0.00%)
Urinary incontinence ^† 1	4/50 (8.00%)	0/64 (0.00%)
Urinary retention ^† 1	5/50 (10.00%)	0/64 (0.00%)
Urinary tract obstruction ^† 1	1/50 (2.00%)	0/64 (0.00%)
Urinary tract pain ^† 1	2/50 (4.00%)	0/64 (0.00%)
Reproductive system and breast disorders
Penile pain ^† 1	1/50 (2.00%)	0/64 (0.00%)
Vaginal hemorrhage ^† 1	1/50 (2.00%)	0/64 (0.00%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Aspiration ^† 1	2/50 (4.00%)	0/64 (0.00%)
Atelectasis ^† 1	25/50 (50.00%)	0/64 (0.00%)
Bronchopulmonary hemorrhage ^† 1	1/50 (2.00%)	0/64 (0.00%)
Cough ^† 1	22/50 (44.00%)	0/64 (0.00%)
Diffuse aveolar hemorrhage ^† 1	0/50 (0.00%)	1/64 (1.56%)
Dyspnea ^† 1	28/50 (56.00%)	4/64 (6.25%)
Epistaxis ^† 1	8/50 (16.00%)	4/64 (6.25%)
Hemoptysis ^† 1	3/50 (6.00%)	0/64 (0.00%)
Hiccups ^† 1	1/50 (2.00%)	0/64 (0.00%)
Hoarseness ^† 1	1/50 (2.00%)	1/64 (1.56%)
Hypoxia ^† 1	22/50 (44.00%)	4/64 (6.25%)
Nasal congestion ^† 1	8/50 (16.00%)	0/64 (0.00%)
Pleural effusion ^† 1	17/50 (34.00%)	1/64 (1.56%)
Pleuritic pain ^† 1	5/50 (10.00%)	0/64 (0.00%)
Postnasal drip ^† 1	5/50 (10.00%)	0/64 (0.00%)
Productive cough ^† 1	6/50 (12.00%)	0/64 (0.00%)
Pulmonary edema ^† 1	10/50 (20.00%)	0/64 (0.00%)
Pulmonary hypertension ^† 1	1/50 (2.00%)	0/64 (0.00%)
Respiratory failure ^† 1	8/50 (16.00%)	3/64 (4.69%)
Rhinorrhea ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sneezing ^† 1	1/50 (2.00%)	0/64 (0.00%)
Sore throat ^† 1	12/50 (24.00%)	0/64 (0.00%)
Wheezing ^† 1	6/50 (12.00%)	1/64 (1.56%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	2/50 (4.00%)	0/64 (0.00%)
Dry skin ^† 1	7/50 (14.00%)	0/64 (0.00%)
Hematoma ^† 1	5/50 (10.00%)	0/64 (0.00%)
Hot flashes ^† 1	2/50 (4.00%)	0/64 (0.00%)
Papulopustular rash ^† 1	2/50 (4.00%)	0/64 (0.00%)
Pruritus ^† 1	7/50 (14.00%)	1/64 (1.56%)
Purpura ^† 1	17/50 (34.00%)	0/64 (0.00%)
Rash acneiform ^† 1	1/50 (2.00%)	0/64 (0.00%)
Rash maculo-papular ^† 1	12/50 (24.00%)	2/64 (3.13%)
Skin nodules ^† 1	1/50 (2.00%)	0/64 (0.00%)
Skin ulceration ^† 1	17/50 (34.00%)	0/64 (0.00%)
Vascular disorders
Flushing ^† 1	3/50 (6.00%)	0/64 (0.00%)
Hypertension ^† 1	2/50 (4.00%)	3/64 (4.69%)
Hypotension ^† 1	14/50 (28.00%)	7/64 (10.94%)
Superficial thrombophlebitis ^† 1	1/50 (2.00%)	0/64 (0.00%)
Thromboembolic event ^† 1	6/50 (12.00%)	2/64 (3.13%)
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

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Name/Title:	John Welch, M.D., Ph.D.
Organization:	Washington University School of Medicine
Phone:	314-362-2626
EMail:	jwelch@wustl.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Welch JS, Petti AA, Miller CA, Fronick CC, O'Laughlin M, Fulton RS, Wilson RK, Baty JD, Duncavage EJ, Tandon B, Lee YS, Wartman LD, Uy GL, Ghobadi A, Tomasson MH, Pusic I, Romee R, Fehniger TA, Stockerl-Goldstein KE, Vij R, Oh ST, Abboud CN, Cashen AF, Schroeder MA, Jacoby MA, Heath SE, Luber K, Janke MR, Hantel A, Khan N, Sukhanova MJ, Knoebel RW, Stock W, Graubert TA, Walter MJ, Westervelt P, Link DC, DiPersio JF, Ley TJ. TP53 and Decitabine in Acute Myeloid Leukemia and Myelodysplastic Syndromes. N Engl J Med. 2016 Nov 24;375(21):2023-2036. doi: 10.1056/NEJMoa1605949.

Layout table for additonal information

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01687400
Other Study ID Numbers:	201210102
First Submitted:	September 13, 2012
First Posted:	September 18, 2012
Results First Submitted:	June 13, 2018
Results First Posted:	October 2, 2018
Last Update Posted:	October 2, 2018

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