Trial Outcomes & Findings for Azacitidine in Patients Undergoing Matched Unrelated Stem Cell Transplantation (NCT NCT01747499)
NCT ID: NCT01747499
Last Updated: 2019-10-16
Results Overview
The MTD is defined as the dose level immediately below the dose level at which patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
28 days
Results posted on
2019-10-16
Participant Flow
Participant milestones
| Measure |
Cohort 1
Conditioning treatment
Transplant on Day 0
15 mg/m\^2 azacitidine Days 7-11
15 mg/m\^2 azacitidine Days 35-39
15 mg/m\^2 azacitidine Days 63-67
15 mg/m\^2 azacitidine Days 91-95
|
Cohort 2
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
39
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
4
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
2
|
15
|
Reasons for withdrawal
| Measure |
Cohort 1
Conditioning treatment
Transplant on Day 0
15 mg/m\^2 azacitidine Days 7-11
15 mg/m\^2 azacitidine Days 35-39
15 mg/m\^2 azacitidine Days 63-67
15 mg/m\^2 azacitidine Days 91-95
|
Cohort 2
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Overall Study
Steroid refractory aGvHD
|
1
|
0
|
0
|
1
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
6
|
|
Overall Study
Developed AML and death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Determined not to be eligible
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Azacitidine in Patients Undergoing Matched Unrelated Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Conditioning treatment
Transplant on Day 0
15 mg/m\^2 azacitidine Days 7-11
15 mg/m\^2 azacitidine Days 35-39
15 mg/m\^2 azacitidine Days 63-67
15 mg/m\^2 azacitidine Days 91-95
|
Cohort 2
n=3 Participants
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 Participants
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 Participants
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=39 Participants
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
57 years
n=7 Participants
|
63 years
n=5 Participants
|
58.5 years
n=4 Participants
|
59 years
n=21 Participants
|
59 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
54 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
39 participants
n=21 Participants
|
54 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe MTD is defined as the dose level immediately below the dose level at which patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity.
Outcome measures
| Measure |
Phase I
n=15 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Phase I: to Determine the Maximum Tolerated Dose (MTD) of Azacitidine in Patients Undergoing Matched (8 Out of 8) Unrelated Donor Transplant for Any Hematological Malignancy in Remission or With Stable Disease.
|
45 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day +180Population: One patient was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.
GVHD rate and severity will be assessed based on modified Glucksberg criteria. Grade II-IV and III-IV aGVHD in first 180 days after transplant will be assessed.
Outcome measures
| Measure |
Phase I
n=38 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Phase II: Number of Participants With Grades II-IV Acute GvHD
|
16 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day +180Population: One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.
GVHD rate and severity will be assessed based on modified Glucksberg criteria.
Outcome measures
| Measure |
Phase I
n=3 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
n=3 Participants
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 Participants
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 Participants
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=38 Participants
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Rate of Grades III-IV aGVHD at Day +180.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: One year after transplantPopulation: One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.
Date of transplant to the date of death from any cause.
Outcome measures
| Measure |
Phase I
n=3 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
n=3 Participants
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 Participants
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 Participants
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=38 Participants
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Overall Survival as Measured by Number of Participants Alive at 1 Year After Transplant
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day +140Population: One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.
Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.
Outcome measures
| Measure |
Phase I
n=3 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
n=3 Participants
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 Participants
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 Participants
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=38 Participants
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Treatment-related Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within the first year of transplantPopulation: One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.
Recurrence of the original malignant disease after transplantation. The time to relapse is the time to the first observation of hematologic, radiographic, or cytogenetic changes, which result in characterization as relapse.
Outcome measures
| Measure |
Phase I
n=3 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
n=3 Participants
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 Participants
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 Participants
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=38 Participants
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Number of Participants Who Relapsed Within the First Year of Transplant
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: One year after transplantPopulation: One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.
Outcome measures
| Measure |
Phase I
n=3 Participants
Conditioning treatment
Transplant on Day 0
Azacitidine Days 7-11
Azacitidine Days 35-39
Azacitidine Days 63-67
Azacitidine Days 91-95
|
Cohort 2
n=3 Participants
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 Participants
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 Participants
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=38 Participants
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
Rate of Chronic GvHD
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
27 Participants
|
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase II Cohort
Serious events: 23 serious events
Other events: 39 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
Conditioning treatment
Transplant on Day 0
15 mg/m\^2 azacitidine Days 7-11
15 mg/m\^2 azacitidine Days 35-39
15 mg/m\^2 azacitidine Days 63-67
15 mg/m\^2 azacitidine Days 91-95
|
Cohort 2
n=3 participants at risk
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 participants at risk
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 participants at risk
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=39 participants at risk
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
General disorders
Fever
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic respiratory failure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapsed acute leukemia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Acute kidney failure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
15.4%
6/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Vascular access complication
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
12.8%
5/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Respiratory infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
HHV-6
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Edema limbs
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Conditioning treatment
Transplant on Day 0
15 mg/m\^2 azacitidine Days 7-11
15 mg/m\^2 azacitidine Days 35-39
15 mg/m\^2 azacitidine Days 63-67
15 mg/m\^2 azacitidine Days 91-95
|
Cohort 2
n=3 participants at risk
Conditioning treatment
Transplant on Day 0
30 mg/m\^2 azacitidine Days 7-11
30 mg/m\^2 azacitidine Days 35-39
30 mg/m\^2 azacitidine Days 63-67
30 mg/m\^2 azacitidine Days 91-95
|
Cohort 3
n=3 participants at risk
Conditioning treatment
Transplant on Day 0
37.5 mg/m\^2 azacitidine Days 7-11
37.5 mg/m\^2 azacitidine Days 35-39
37.5 mg/m\^2 azacitidine Days 63-67
37.5 mg/m\^2 azacitidine Days 91-95
|
Cohort 4
n=6 participants at risk
Conditioning treatment
Transplant on Day 0
45 mg/m\^2 azacitidine Days 7-11
45 mg/m\^2 azacitidine Days 35-39
45 mg/m\^2 azacitidine Days 63-67
45 mg/m\^2 azacitidine Days 91-95
|
Phase II Cohort
n=39 participants at risk
Conditioning treatment
Transplant on Day 0
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 7-11
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 35-39
Dose determined in Phase I - 45 mg/m\^2 azacitidine Days 63-67
Dose determined in Phase I - 45 mg/m\^2 attitudinize Days 91-95
|
|---|---|---|---|---|---|
|
General disorders
Fever
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
6/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
10.3%
4/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
4/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
4/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
35.9%
14/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
35.9%
14/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
12.8%
5/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Localized edema
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Heart failure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Cardiac disorders
Tachycardia (NOS)
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Eye disorders
Vision changes (not otherwise specified)
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Eye disorders
Watering eyes
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
10.3%
4/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Mouth gumminess
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
6/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
51.3%
20/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Sore in mouth
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Chills
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Edema limbs
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Fatigue
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
10.3%
4/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Neck edema
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
General disorders
Pain
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
BK virus
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
C. Difficile
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
CMV Positive Culture
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
CMV Viremia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Catheter related infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Coagulase Negative Staphyloccus-Bacteremia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Coronavirus OC43 Parainfluenza virus Type 3
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
E. coli bacteremia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
10.3%
4/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Enterocolitis infectious
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Healthcare associated pneumonia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Influenza A
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Rhinovirus positive culture
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Sinusitis (rhinovirus/enterovirus)
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Streptococcus mitis bacteremia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Injury, poisoning and procedural complications
Dog bite to finger
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
4/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
15.4%
6/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
4/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
4/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
10.3%
4/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Ejection fracture decreased
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
INR increased
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
4/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
43.6%
17/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
53.8%
21/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
51.3%
20/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
Weight loss
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
38.5%
15/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
12.8%
5/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
30.8%
12/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
100.0%
3/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Drooling
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Facial droop
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
66.7%
2/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
50.0%
3/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
7.7%
3/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Bladder spasm
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Reproductive system and breast disorders
Perianal pain
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Acute worsening of COPD
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Blanching erythema
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Erythema (face)
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Erythema at catheter site
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Lip ulcer
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
5.1%
2/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Rash (sun burn)
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
83.3%
5/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
25.6%
10/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
16.7%
1/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Hot flashes
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
10.3%
4/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
2.6%
1/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
1/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/3 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
33.3%
2/6 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
0.00%
0/39 • -Adverse events (AEs) were collected from Day +7-Day +140 visit or 30 days after their last dose of azacitidine (for patients that did not complete all 4 cycles of treatment). -All AEs were collected for Phase I patients -Only selected adverse events were collected for Phase II patients *all grade 3, 4, or 5 *any that require azacitidine treatment to be delayed, held, or discontinued *any that require modification of GVHD prophylaxis medications *any grade mucositis and any infection
|
Additional Information
Mark A. Schroeder, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place