Trial Outcomes & Findings for Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide (NCT NCT01010217)
NCT ID: NCT01010217
Last Updated: 2020-03-25
Results Overview
Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease. Bayesian monitoring scheme described in Thall, Simon, and Estey (1996) employed to perform interim monitoring of the data during the course of the trial separately within each group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
At 100 days
Results posted on
2020-03-25
Participant Flow
Patients were enrolled during the period from January 2010 through August 2014 and were assigned to the HAPLO arm or the 9/10 MUD arm based on donor availability and physician preference. The 3 arms received identical melphalan-based conditioning chemotherapy and GVHD prophylaxis
Additional arm elderly patients did not accrue any participants so therefore was excluded from summary.
Participant milestones
| Measure |
Haplo Arm
Patients that received a stem cell transplant from a haploidentical donor.
|
1AgMM Related/Unrelated Donors
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
56
|
22
|
6
|
3
|
|
Overall Study
COMPLETED
|
84
|
51
|
21
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
1
|
6
|
3
|
Reasons for withdrawal
| Measure |
Haplo Arm
Patients that received a stem cell transplant from a haploidentical donor.
|
1AgMM Related/Unrelated Donors
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
6
|
3
|
Baseline Characteristics
Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide
Baseline characteristics by cohort
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploindentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
n=6 Participants
Patients receiving a second transplant
|
Myelofibrosis
n=3 Participants
Patients with the diagnosis of Myelofibrosis
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
147 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
90 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
141 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
11 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
111 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Patients with hematologic malignancies without a matched donor
|
84 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
165 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At 100 daysPopulation: Second Transplant and Myelofibrosis was not evaluated due to low accrual.
Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease. Bayesian monitoring scheme described in Thall, Simon, and Estey (1996) employed to perform interim monitoring of the data during the course of the trial separately within each group.
Outcome measures
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploidentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Number of Participants With Non-relapse Mortality (NRM)
|
8 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: six monthsPopulation: Second Transplant and Myelofibrosis was not evaluated due to low accrual.
Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease.
Outcome measures
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploidentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Number of Participants With Non Related Mortality (NRM)
|
17 Participants
|
15 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Second Transplant and Myelofibrosis was not evaluated due to low accrual.
Outcome measures
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploidentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Engraftments
|
80 Participants
|
50 Participants
|
21 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 100 daysPopulation: Second Transplant and Myelofibrosis was not evaluated due to low accrual
Acute Graft vs host disease
Outcome measures
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploidentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Grade III-IV aGVHD
|
11 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Second Transplant and Myelofibrosis was not evaluated due to low accrual.
Chronic graft vs host disease
Outcome measures
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploidentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
cGVHD
|
11 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Second Transplant and Myelofibrosis was not evaluated due to low accrual.
Participants who have survived without their original disease.
Outcome measures
| Measure |
Haplo Arm
n=84 Participants
Patients that received a transplant from a haploidentical donor
|
1AgMM Related/Unrelated Donors
n=51 Participants
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 Participants
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
Patients receiving a second transplant
|
Myelofibrosis
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Disease Free Survival
|
50 Participants
|
24 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Haplo Arm
Serious events: 8 serious events
Other events: 84 other events
Deaths: 22 deaths
1AgMM Related/Unrelated Donors
Serious events: 11 serious events
Other events: 51 other events
Deaths: 21 deaths
MUD Donor
Serious events: 7 serious events
Other events: 21 other events
Deaths: 9 deaths
Second Transplant
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Myelofibrosis
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Haplo Arm
n=84 participants at risk
Patients that received a transplant from a haploindentical donor
|
1AgMM Related/Unrelated Donors
n=51 participants at risk
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 participants at risk
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
n=6 participants at risk
Patients receiving a second transplant
|
Myelofibrosis
n=3 participants at risk
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute renal failure
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Adenocirus viremia
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Nervous system disorders
Altered mental status
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Renal and urinary disorders
BK virus associated hemorrhagic cystitis
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Cardiomyopathy
|
3.6%
3/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Chronic GI GVHD
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
GI GVHD
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
7.8%
4/51 • From the start of the preparative regiment up to day 100.
|
9.5%
2/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
General disorders
Headache
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Bacterial infection
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
33.3%
2/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Fungal infection
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Viral infection
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
9.5%
2/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Fungal pneumonia
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Graft failure
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Upper GI GVHD
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
Other adverse events
| Measure |
Haplo Arm
n=84 participants at risk
Patients that received a transplant from a haploindentical donor
|
1AgMM Related/Unrelated Donors
n=51 participants at risk
Patients that received a transplant from a 1 antigen mismatched related or unrelated donor
|
MUD Donor
n=21 participants at risk
Patients that received a transplant from a matched unrelated donor
|
Second Transplant
n=6 participants at risk
Patients receiving a second transplant
|
Myelofibrosis
n=3 participants at risk
Patients with the diagnosis of Myelofibrosis
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Chemo Burn
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Renal and urinary disorders
Acute renal failure
|
4.8%
4/84 • From the start of the preparative regiment up to day 100.
|
9.8%
5/51 • From the start of the preparative regiment up to day 100.
|
14.3%
3/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Nervous system disorders
Altered mental status
|
4.8%
4/84 • From the start of the preparative regiment up to day 100.
|
5.9%
3/51 • From the start of the preparative regiment up to day 100.
|
9.5%
2/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Autoimmune hemolytic anemia
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Renal and urinary disorders
BK virus associated hemorrhagic cystitis
|
44.0%
37/84 • From the start of the preparative regiment up to day 100.
|
35.3%
18/51 • From the start of the preparative regiment up to day 100.
|
28.6%
6/21 • From the start of the preparative regiment up to day 100.
|
66.7%
4/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
C difficile colitis
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Cardiomyopathy
|
3.6%
3/84 • From the start of the preparative regiment up to day 100.
|
5.9%
3/51 • From the start of the preparative regiment up to day 100.
|
9.5%
2/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Chorioretinitis
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Chronic GI GVHD
|
4.8%
4/84 • From the start of the preparative regiment up to day 100.
|
5.9%
3/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Chronic Liver GVHD
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Eye disorders
Chronic Ocular GVHD
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
General disorders
Chronic Oral GVHD
|
3.6%
3/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Skin and subcutaneous tissue disorders
Chronic Skin GVHD
|
8.3%
7/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
CMV chorioretinitis
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
DAH
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Delayed Engraftment
|
3.6%
3/84 • From the start of the preparative regiment up to day 100.
|
5.9%
3/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Diarrhea
|
65.5%
55/84 • From the start of the preparative regiment up to day 100.
|
64.7%
33/51 • From the start of the preparative regiment up to day 100.
|
71.4%
15/21 • From the start of the preparative regiment up to day 100.
|
66.7%
4/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Disseminated toxoplasmosis
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Elevated ALK Phosphatase
|
8.3%
7/84 • From the start of the preparative regiment up to day 100.
|
9.8%
5/51 • From the start of the preparative regiment up to day 100.
|
14.3%
3/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Elevated ALT
|
22.6%
19/84 • From the start of the preparative regiment up to day 100.
|
23.5%
12/51 • From the start of the preparative regiment up to day 100.
|
23.8%
5/21 • From the start of the preparative regiment up to day 100.
|
50.0%
3/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Elevated AST
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Elevated bilirubin
|
25.0%
21/84 • From the start of the preparative regiment up to day 100.
|
39.2%
20/51 • From the start of the preparative regiment up to day 100.
|
14.3%
3/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Elevated WBC
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Endocarditis
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Investigations
Fever
|
15.5%
13/84 • From the start of the preparative regiment up to day 100.
|
9.8%
5/51 • From the start of the preparative regiment up to day 100.
|
9.5%
2/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Investigations
Fluid overload
|
72.6%
61/84 • From the start of the preparative regiment up to day 100.
|
56.9%
29/51 • From the start of the preparative regiment up to day 100.
|
85.7%
18/21 • From the start of the preparative regiment up to day 100.
|
83.3%
5/6 • From the start of the preparative regiment up to day 100.
|
100.0%
3/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
GI GVHD
|
16.7%
14/84 • From the start of the preparative regiment up to day 100.
|
17.6%
9/51 • From the start of the preparative regiment up to day 100.
|
28.6%
6/21 • From the start of the preparative regiment up to day 100.
|
33.3%
2/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
GI pain
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Skin and subcutaneous tissue disorders
Hand/Foot syndrome
|
4.8%
4/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
General disorders
Headache
|
9.5%
8/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
6.0%
5/84 • From the start of the preparative regiment up to day 100.
|
7.8%
4/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Hypertension
|
21.4%
18/84 • From the start of the preparative regiment up to day 100.
|
37.3%
19/51 • From the start of the preparative regiment up to day 100.
|
23.8%
5/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Idiopathic pneumonitis
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Bacterial infection
|
77.4%
65/84 • From the start of the preparative regiment up to day 100.
|
74.5%
38/51 • From the start of the preparative regiment up to day 100.
|
90.5%
19/21 • From the start of the preparative regiment up to day 100.
|
33.3%
2/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Fungal infection
|
6.0%
5/84 • From the start of the preparative regiment up to day 100.
|
11.8%
6/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Viral Infection
|
83.3%
70/84 • From the start of the preparative regiment up to day 100.
|
70.6%
36/51 • From the start of the preparative regiment up to day 100.
|
81.0%
17/21 • From the start of the preparative regiment up to day 100.
|
83.3%
5/6 • From the start of the preparative regiment up to day 100.
|
100.0%
3/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Liver GVHD
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
General disorders
Metabolic encephalopathy
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
5.9%
3/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Mucositis
|
48.8%
41/84 • From the start of the preparative regiment up to day 100.
|
58.8%
30/51 • From the start of the preparative regiment up to day 100.
|
42.9%
9/21 • From the start of the preparative regiment up to day 100.
|
66.7%
4/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
84/84 • From the start of the preparative regiment up to day 100.
|
100.0%
51/51 • From the start of the preparative regiment up to day 100.
|
100.0%
21/21 • From the start of the preparative regiment up to day 100.
|
100.0%
6/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Neutropenic fever
|
45.2%
38/84 • From the start of the preparative regiment up to day 100.
|
31.4%
16/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
33.3%
2/6 • From the start of the preparative regiment up to day 100.
|
66.7%
2/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
Neutropenic Typhlitis
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Orthostatic hypotension
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
19.0%
16/84 • From the start of the preparative regiment up to day 100.
|
9.8%
5/51 • From the start of the preparative regiment up to day 100.
|
38.1%
8/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Fungal pneumonia
|
4.8%
4/84 • From the start of the preparative regiment up to day 100.
|
9.8%
5/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Infections and infestations
HSV oral infection
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Graft failure
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.0%
5/84 • From the start of the preparative regiment up to day 100.
|
13.7%
7/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Renal and urinary disorders
Renal insufficiency
|
13.1%
11/84 • From the start of the preparative regiment up to day 100.
|
9.8%
5/51 • From the start of the preparative regiment up to day 100.
|
9.5%
2/21 • From the start of the preparative regiment up to day 100.
|
33.3%
2/6 • From the start of the preparative regiment up to day 100.
|
100.0%
3/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Secondary graft failure
|
13.1%
11/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
14.3%
3/21 • From the start of the preparative regiment up to day 100.
|
16.7%
1/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Nervous system disorders
Seizure
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Skin and subcutaneous tissue disorders
Skin GVHD
|
25.0%
21/84 • From the start of the preparative regiment up to day 100.
|
33.3%
17/51 • From the start of the preparative regiment up to day 100.
|
28.6%
6/21 • From the start of the preparative regiment up to day 100.
|
66.7%
4/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
4.8%
1/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Investigations
Infusion reaction
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
0.00%
0/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
7.8%
4/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Nervous system disorders
Tremors
|
2.4%
2/84 • From the start of the preparative regiment up to day 100.
|
2.0%
1/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Blood and lymphatic system disorders
TMA
|
1.2%
1/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
|
Gastrointestinal disorders
Upper GI GVHD
|
31.0%
26/84 • From the start of the preparative regiment up to day 100.
|
21.6%
11/51 • From the start of the preparative regiment up to day 100.
|
38.1%
8/21 • From the start of the preparative regiment up to day 100.
|
50.0%
3/6 • From the start of the preparative regiment up to day 100.
|
33.3%
1/3 • From the start of the preparative regiment up to day 100.
|
|
Hepatobiliary disorders
Veno occlusive disease
|
0.00%
0/84 • From the start of the preparative regiment up to day 100.
|
3.9%
2/51 • From the start of the preparative regiment up to day 100.
|
0.00%
0/21 • From the start of the preparative regiment up to day 100.
|
0.00%
0/6 • From the start of the preparative regiment up to day 100.
|
0.00%
0/3 • From the start of the preparative regiment up to day 100.
|
Additional Information
Dr. Stefan O Ciurea, Associate Profeddor of Stem Cell Transplantation
UT MD Anderson Cancer Center
Phone: 713-745-0146
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place