Trial Outcomes & Findings for A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL (NCT NCT01483690)

Last Updated: 2020-10-27

Results Overview

To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-10-27

Participant Flow

This is a pilot study where 16 patients are anticipated to be enrolled. Anticipated enrollment will take 2.5 years.

Participant milestones

Participant milestones
Measure	Initial Dose Level Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Overall Study STARTED	5	18
Overall Study COMPLETED	3	13
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Initial Dose Level Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Overall Study Adverse Event	1	2
Overall Study clinical deterioration	1	0
Overall Study Physician Decision	0	2
Overall Study exclusionary procedure	0	1

Baseline Characteristics

A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial Dose Level n=5 Participants Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level n=18 Participants Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21	Total n=23 Participants Total of all reporting groups
Age, Continuous	12.5 years n=5 Participants	12.0 years n=7 Participants	12.0 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
CNS Status CNS 1	4 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants
CNS Status CNS 2	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
CNS Status CNS 3	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Prior hematopoietic cell transplantation (HCT) Yes had prior HCT	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Prior hematopoietic cell transplantation (HCT) No did not have prior HCT	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Relapse # at enrollment 2nd Relapse	2 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants
Relapse # at enrollment 3rd Relapse	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Relapse # at enrollment Refractory	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Participants who entered the study.

To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.

Outcome measures

Outcome measures
Measure	Initial Dose Level n=5 Participants Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level n=18 Participants Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT). # of patients with DLT	2 Participants	1 Participants
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT). # of patients without DLT	2 Participants	12 Participants
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT). # of patients not evaluable	1 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Patients who entered the study.

Bone marrow evaluation was performed on Day 35 of study to evaluate treatment response. CR defined as attaining M1 marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease in addition to recovery of peripheral blood counts (ANC \>750/uL and platelet count \>75,000/uL). CRp was defined as attaining an M1 marrow with no evidence of circulating blasts or extramedullary disease in addition to recovery of ANC but insufficient recovery of platelets. CRi was attaining M1 marrow with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC with or without sufficient recovery of platelets. PR was defined as no evidence of circulating blasts and achievement of M2 marrow (5-25% blasts) without new sites of disease and with recovery of ANC. SD is for patients who did not meet the criteria for PR, CR, CRp, or CRi. PD is an increase of at least 25% in the absolute number of leukemia cells or development of new sites.

Outcome measures

Outcome measures
Measure	Initial Dose Level n=5 Participants Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level n=18 Participants Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Disease Response Rate After Treatment. complete response (CR)	0 Participants	1 Participants
Disease Response Rate After Treatment. complete response without platelet recovery (CRp)	1 Participants	3 Participants
Disease Response Rate After Treatment. complete remission with incomplete recovery (CRi)	1 Participants	3 Participants
Disease Response Rate After Treatment. stable disease (SD)	1 Participants	4 Participants
Disease Response Rate After Treatment. patient not evaluable for response	2 Participants	7 Participants

Adverse Events

Initial Dose Level

Serious events: 5 serious events

Other events: 5 other events

Deaths: 5 deaths

Modified Dose Level

Serious events: 18 serious events

Other events: 18 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Research Coordinator, Consortia

Therapeutic Advancements of Childhood Leukemia and Lymphoma

Phone: 323-361-5312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	Initial Dose Level n=5 participants at risk Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level n=18 participants at risk Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Metabolism and nutrition disorders Anemia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	61.1% 11/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Acidosis	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Endocrine disorders Acute kidney injury	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Agitation	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Alanine aminotransferase increase	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Alkaline phosphatase increased	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	16.7% 3/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations Ano-rectal infection	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Blood bilirubin increased	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Nervous system disorders Encephalopathy	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders GGT increased	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyperglycemia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypernatermia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypertriglyceridemia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalemia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	50.0% 9/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Cardiac disorders Hypotension	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Cardiac disorders Left ventricular systolic dysfunction	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Lipase increased	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations Lung infection	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Lymphocyte count decreased	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Lymphocyte count increased	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Nervous system disorders nervous system disorder - other	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Blood and lymphatic system disorders neutrophil count decrease	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	27.8% 5/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Nervous system disorders Altered mental status	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Blood and lymphatic system disorders platelet count decreased	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	38.9% 7/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders respiratory failure	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations sepsis	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	22.2% 4/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders serum amylase increased	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Cardiac disorders sinus bradycardia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations soft tissue infection	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.

Other adverse events
Measure	Initial Dose Level n=5 participants at risk Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24	Modified Dose Level n=18 participants at risk Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Gastrointestinal disorders Abdominal pain	60.0% 3/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Acidosis	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Alanine aminotransferase increased	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	16.7% 3/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Alkaline phosphatase increased	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	83.3% 15/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Anorexia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	22.2% 4/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Gastrointestinal disorders Ascites	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Aspartate aminotransferase increased	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	22.2% 4/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Blood and lymphatic system disorders Blood bilirubin increased	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	27.8% 5/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations Catheter related infection	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	16.7% 3/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Cholesterol high	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Gastrointestinal disorders Colitis	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Creatinine increased	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Dehydration	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Delirium	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Depressed level of consciousness	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Dizziness	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Dyspnea	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations Enterocolitis infectious	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Epistaxis	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Infections and infestations Febrile neutropenia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	83.3% 15/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Fever	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
General disorders Generalized muscle weakness	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Gamma-glutamyl transferase increased	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Gastrointestinal disorders Hepatobiliary disorders - Other	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyperglycemia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	16.7% 3/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	5.6% 1/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypermagnesemia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Cardiac disorders Hypertension	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	16.7% 3/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypertriglyceridemia	20.0% 1/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	11.1% 2/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypocalcemia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	27.8% 5/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypoglycemia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	0.00% 0/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalemia	40.0% 2/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.	27.8% 5/18 • Adverse events and suspected adverse reactions will be collected and reported on the electronic case report forms beginning with the first dose of decitabine and vorinostat until 30 days following last dose of decitabine and vorinostat. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same from clinicaltrials.gov definitions.