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.
COMPLETED
PHASE2
20 participants
Day 100
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
| 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
| 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
| 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 100Population: (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
| 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 yearDefined 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
| 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 30Platelet 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
| 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 30Defined 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
| 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 100Determined 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
| 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 yearWill be summarized with a proportion and a 95% confidence interval.
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 yearOutcome 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 yearOutcome 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)
Transplant (N=17)
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place