Trial Outcomes & Findings for Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT01707004)

NCT ID: NCT01707004

Last Updated: 2019-11-21

Results Overview

Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Day 100

Results posted on

2019-11-21

Participant Flow

Recruitment of high risk BMT patients with active disease at time of transplant or very high risk to relapse post-transplant.

Participant milestones

Participant milestones
Measure
Decitabine + Bone Marrow Transplant
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Overall Study
STARTED
20
Overall Study
COMPLETED
17
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Decitabine + Bone Marrow Transplant
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Overall Study
Physician Decision
3

Baseline Characteristics

17 participants received transplant on study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Decitabine + Bone Marrow Transplant
n=20 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Age, Categorical
<=18 years
0 Participants
n=20 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=20 Participants
Age, Categorical
>=65 years
9 Participants
n=20 Participants
Sex: Female, Male
Female
6 Participants
n=20 Participants
Sex: Female, Male
Male
14 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
Race (NIH/OMB)
Asian
0 Participants
n=20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=20 Participants
Race (NIH/OMB)
White
20 Participants
n=20 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=20 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
Region of Enrollment
United States
20 participants
n=20 Participants
Donor Type
Matched Related
5 Participants
n=17 Participants • 17 participants received transplant on study
Donor Type
Haplo-identical
12 Participants
n=17 Participants • 17 participants received transplant on study
Disease Risk by DRI
Low Risk
0 Participants
n=20 Participants
Disease Risk by DRI
Intermediate Risk
2 Participants
n=20 Participants
Disease Risk by DRI
High Risk
13 Participants
n=20 Participants
Disease Risk by DRI
Very High Risk
5 Participants
n=20 Participants
HCT-CI Score
0
5 Participants
n=20 Participants
HCT-CI Score
1-2
7 Participants
n=20 Participants
HCT-CI Score
3+
8 Participants
n=20 Participants
Disease Status
AML
15 participants
n=20 Participants
Disease Status
Primary Induction Failure
6 participants
n=20 Participants
Disease Status
Relapsed Disease
7 participants
n=20 Participants
Disease Status
CR1 with high risk features
2 participants
n=20 Participants
Disease Status
MDS
5 participants
n=20 Participants

PRIMARY outcome

Timeframe: Day 100

Population: (2 patients did not receive a transplant due to infectious complications, 1 patient received transplant off protocol)

Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals.

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Overall Survival (OS)
64.7 percentage of participants
Interval 45.5 to 91.9

SECONDARY outcome

Timeframe: Up to 1 year

Defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/ul for three consecutive measurements on different days. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05.

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Time to Neutrophil Recovery
16 days
Interval 16.0 to 19.0

SECONDARY outcome

Timeframe: Up to day 30

Platelet recovery is defined as the first day of a platelet count greater than 20,000/mm\^3 with no platelet transfusions. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05.

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Percentage of Participants With Platelet Recovery by Day 30
58 percentage with plt engraftment, day 30
Interval 31.3 to 78.4

SECONDARY outcome

Timeframe: Day 30

Defined as less than 5% donor chimerism in the cluster of differentiation (CD)3 and CD33 selected cell populations at any time after transplantation. Will be analyzed using KM method.

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Number of Participants With Primary Graft Failure
0 Participants

SECONDARY outcome

Timeframe: Day 100

Determined by the standard bone marrow transplant (BMT) Clinical Trials Network criteria (BMTCTN). Will be analyzed using KM method, a Graft versus Host Disease (GVHD) grade III-IV will be obtained from the KM estimates along with 95% confidence intervals.

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Cumulative Incidence of Grade III-IV Acute GVHD
27.8 percentage of participants
Interval 8.0 to 52.3

SECONDARY outcome

Timeframe: Up to 1 year

Will be summarized with a proportion and a 95% confidence interval.

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Cumulative Incidence of Chronic GVHD According to BMTCTN
40.7 percentage
Interval 6.9 to 74.0

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Number of Participants With Complete Remission After Transplantation
14 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure
Decitabine + Bone Marrow Transplant
n=17 Participants
Pre-transplant Decitabine followed by Bone Marrow Transplant.
Progression Free Survival
141 days
Interval 69.0 to 492.0

Adverse Events

Decitabine (N=20)

Serious events: 0 serious events
Other events: 20 other events
Deaths: 15 deaths

Transplant (N=17)

Serious events: 12 serious events
Other events: 17 other events
Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure
Decitabine (N=20)
n=20 participants at risk
Pre-transplant Decitabine
Transplant (N=17)
n=17 participants at risk
Pre-transplant Decitabine followed by Bone Marrow Transplant
Gastrointestinal disorders
Abdominal pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Diarrhea
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Immune system disorders
Immune system disorders - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Anorectal infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Encephalitis infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Enterocolitis infectious
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Infections and infestations - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Sepsis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Syncope
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Psychiatric disorders
Delirium
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.

Other adverse events

Other adverse events
Measure
Decitabine (N=20)
n=20 participants at risk
Pre-transplant Decitabine
Transplant (N=17)
n=17 participants at risk
Pre-transplant Decitabine followed by Bone Marrow Transplant
Blood and lymphatic system disorders
Anemia
100.0%
20/20 • Number of events 65 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 202 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Blood and lymphatic system disorders
Febrile Neutropenia
10.0%
2/20 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 7 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Platelet Count Decreased
90.0%
18/20 • Number of events 57 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 139 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
White Blood Cell Decreased
85.0%
17/20 • Number of events 30 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 105 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Neutrophil Count Decreased
65.0%
13/20 • Number of events 30 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 89 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Lymphocyte count decreased
80.0%
16/20 • Number of events 30 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
94.1%
16/17 • Number of events 141 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Aspartate aminotransferase increased
10.0%
2/20 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
88.2%
15/17 • Number of events 31 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Alanine aminotransferase increased
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 29 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Alkaline phosphatase increased
25.0%
5/20 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
64.7%
11/17 • Number of events 22 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Creatinine increased
15.0%
3/20 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 26 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Weight loss
10.0%
2/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
64.7%
11/17 • Number of events 42 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
GGT increased
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 26 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Blood bilirubin increased
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
58.8%
10/17 • Number of events 19 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Weight gain
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 12 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
INR increased
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
29.4%
5/17 • Number of events 6 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Electrocardiogram QT corrected interval prolonged
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Lymphocyte count increased
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
CD4 lymphocytes decreased
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Investigations
Cholesterol high
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Anorexia
20.0%
4/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 37 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypoalbuminemia
20.0%
4/20 • Number of events 6 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 80 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypokalemia
30.0%
6/20 • Number of events 12 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
94.1%
16/17 • Number of events 76 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypomagnesemia
25.0%
5/20 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 135 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hyponatremia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 28 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypernatremia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
64.7%
11/17 • Number of events 37 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypophosphatemia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 25 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypocalcemia
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
52.9%
9/17 • Number of events 22 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Dehydration
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
41.2%
7/17 • Number of events 13 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hyperkalemia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
41.2%
7/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypermagnesemia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
47.1%
8/17 • Number of events 13 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hyperglycemia
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 15 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypertriglyceridemia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
41.2%
7/17 • Number of events 9 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Hypercalcemia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Fatigue
55.0%
11/20 • Number of events 13 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
76.5%
13/17 • Number of events 39 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Edema limbs
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
76.5%
13/17 • Number of events 28 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Chills
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
41.2%
7/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Fever
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Pain
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Non-cardiac chest pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Facial pain
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Edema face
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Infusion related reaction
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Localized edema
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
General disorders
Malaise
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Nausea
45.0%
9/20 • Number of events 12 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
88.2%
15/17 • Number of events 39 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Mucositis oral
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
100.0%
17/17 • Number of events 49 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Diarrhea
20.0%
4/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
88.2%
15/17 • Number of events 103 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Vomiting
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
76.5%
13/17 • Number of events 43 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Abdominal pain
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
64.7%
11/17 • Number of events 22 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Constipation
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
58.8%
10/17 • Number of events 16 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Dry mouth
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
58.8%
10/17 • Number of events 10 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Dyspepsia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
29.4%
5/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Hemorrhoids
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 6 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Bloating
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Dysphagia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Esophagitis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Rectal pain
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Abdominal distension
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Ascites
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Enterocolitis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Hemorrhoidal hemorrhage
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Lip pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Oral hemorrhage
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Gastrointestinal disorders
Rectal hemorrhage
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
52.9%
9/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Dyspnea
15.0%
3/20 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
29.4%
5/17 • Number of events 9 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Sore throat
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 14 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Epistaxis
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
29.4%
5/17 • Number of events 10 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Hypoxia
5.0%
1/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 9 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Hiccups
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Apnea
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Rash maculo-papular
5.0%
1/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
58.8%
10/17 • Number of events 19 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Dry skin
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
52.9%
9/17 • Number of events 10 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
52.9%
9/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 9 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Skin ulceration
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Rash acneiform
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Infections and infestations - Other, specify
20.0%
4/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Lung infection
15.0%
3/20 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Urinary tract infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 6 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Mucosal infection
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Anorectal infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Catheter related infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Encephalitis infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Enterocolitis infectious
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Skin infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Infections and infestations
Upper respiratory infection
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
20.0%
4/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
41.2%
7/17 • Number of events 18 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Back pain
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
29.4%
5/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Bone pain
15.0%
3/20 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Myalgia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Arthralgia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
0.00%
0/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Vascular disorders
Hypertension
35.0%
7/20 • Number of events 15 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
70.6%
12/17 • Number of events 88 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Vascular disorders
Hypotension
20.0%
4/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
52.9%
9/17 • Number of events 20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Vascular disorders
Flushing
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Vascular disorders
Hematoma
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Vascular disorders
Thromboembolic event
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Vascular disorders
Hot flashes
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Dysgeusia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
64.7%
11/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Dizziness
10.0%
2/20 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
47.1%
8/17 • Number of events 14 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Headache
15.0%
3/20 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 10 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Tremor
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Peripheral sensory neuropathy
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Presyncope
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Nervous system disorders
Syncope
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Hematuria
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
29.4%
5/17 • Number of events 10 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Proteinuria
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 7 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Renal and urinary disorders - Other, specify
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Acute kidney injury
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 6 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Cystitis noninfective
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Urinary frequency
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Urinary tract pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Hemoglobinuria
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Urinary incontinence
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Urinary urgency
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Renal and urinary disorders
Urine discoloration
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Cardiac disorders
Sinus tachycardia
30.0%
6/20 • Number of events 8 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
64.7%
11/17 • Number of events 30 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Cardiac disorders
Atrial fibrillation
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Cardiac disorders
Cardiac disorders - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Cardiac disorders
Palpitations
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Cardiac disorders
Sinus bradycardia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Psychiatric disorders
Confusion
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Psychiatric disorders
Insomnia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Psychiatric disorders
Anxiety
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Psychiatric disorders
Depression
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 4 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Psychiatric disorders
Delirium
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Eye disorders
Dry eye
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
23.5%
4/17 • Number of events 5 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Eye disorders
Eye disorders - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
17.6%
3/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Eye disorders
Conjunctivitis
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Eye disorders
Cataract
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Eye disorders
Photophobia
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
0.00%
0/17 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Immune system disorders
Immune system disorders - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
35.3%
6/17 • Number of events 11 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Immune system disorders
Allergic reaction
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Injury, poisoning and procedural complications
Bruising
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 2 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Injury, poisoning and procedural complications
Fall
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Injury, poisoning and procedural complications
Vascular access complication
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Reproductive system and breast disorders
Breast pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Reproductive system and breast disorders
Genital edema
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Reproductive system and breast disorders
Gynecomastia
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
11.8%
2/17 • Number of events 3 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Ear and labyrinth disorders
Ear pain
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
Ear and labyrinth disorders
Hearing impaired
0.00%
0/20 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.
5.9%
1/17 • Number of events 1 • Adverse Events (AEs) data were collected from registration to 1 year post-transplant.
AEs were assessed at regularly scheduled follow up visits where physical exams and labs were performed. AEs reported here include grade 3-5 and adverse events that were not related to the disease state. AEs are reported for all participants who received Decitabine, 17 (+ 1 off protocol) participants who received the transplant.

Additional Information

Aric Hall

UW Carbone Cancer Center

Phone: 608-262-1604

Results disclosure agreements

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