Trial Outcomes & Findings for Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma (NCT NCT01700946)
NCT ID: NCT01700946
Last Updated: 2022-09-28
Results Overview
Estimate the 3-year survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
3 years of follow-up since the on-study date
Results posted on
2022-09-28
Participant Flow
Eighty (80) participants were enrolled on study. Forty-two (42) participants for the outcome measures and thirty-eight (38) donors who are not included in the analysis.
Participant milestones
| Measure |
STANDARD RISK
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
24
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
Reasons for withdrawal
| Measure |
STANDARD RISK
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
7
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Failed to achieve Complete Remission after Induction Block III
|
0
|
2
|
|
Overall Study
Relapse
|
2
|
1
|
|
Overall Study
Unacceptable toxicity
|
1
|
0
|
Baseline Characteristics
Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Baseline characteristics by cohort
| Measure |
STANDARD RISK
n=18 Participants
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 Participants
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
1 to 9 years
|
6 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Customized
>=10 years
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 years of follow-up since the on-study dateEstimate the 3-year survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy.
Outcome measures
| Measure |
STANDARD RISK
n=18 Participants
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 Participants
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=42 Participants
All patients who received the protocol-specified therapy.
|
ALLR17
All patients who had MRD data at the end of Remission Induction
|
|---|---|---|---|---|
|
3-year Overall Survival Rate of Patients With Relapsed ALL
|
94.4 percentage of participants
Interval 66.6 to 99.2
|
55.5 percentage of participants
Interval 33.0 to 73.2
|
72.63 percentage of participants
Interval 55.95 to 83.85
|
—
|
PRIMARY outcome
Timeframe: 3 years of follow-up since the on-study dateEstimate the 3-year event-free survival rate of participants with first relapse or primary refractory precursor B-cell ALL treated with risk-directed therapy.
Outcome measures
| Measure |
STANDARD RISK
n=18 Participants
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 Participants
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=42 Participants
All patients who received the protocol-specified therapy.
|
ALLR17
All patients who had MRD data at the end of Remission Induction
|
|---|---|---|---|---|
|
3-year Event-free Survival Rates in Patients With Relapsed ALL
|
83.3 percentage of participants
Interval 56.8 to 94.3
|
55.7 percentage of participants
Interval 33.2 to 73.4
|
67.83 percentage of participants
Interval 51.04 to 79.9
|
—
|
SECONDARY outcome
Timeframe: At end of induction (approximately 3 months)Population: On ALLR18, a total of 42 patients enrolled. Of them, 24 patients had MRD data at the end of Remission Induction. On ALLR17, a total of 40 patients enrolled. Of them, 32 patients had MRD data at the end of Remission Induction
To determine minimal residual disease (MRD) levels at the end of remission induction therapy for participants with relapsed precursor B-cell ALL and compare the results with those in protocol ALLR17 (NCT00186875).
Outcome measures
| Measure |
STANDARD RISK
n=14 Participants
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=10 Participants
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=24 Participants
All patients who received the protocol-specified therapy.
|
ALLR17
n=32 Participants
All patients who had MRD data at the end of Remission Induction
|
|---|---|---|---|---|
|
Proportion of Participants With Positive Minimal Residual Disease
MRD end-induction: Negative
|
14 Participants
|
6 Participants
|
20 Participants
|
22 Participants
|
|
Proportion of Participants With Positive Minimal Residual Disease
MRD end-induction: Positive
|
0 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline and at the end of Block I (approximately 5 weeks after the on-study date)Population: Of the 42 patients enrolled, 34 patients had At Baseline data; 42 patients had data At Block I
To estimate mean levels of CD20 expression at baseline, during treatment with dexamethasone-containing chemotherapy and following rituximab treatment in Block I of remission induction therapy for relapsed precursor B-cell ALL.
Outcome measures
| Measure |
STANDARD RISK
n=18 Participants
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 Participants
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=42 Participants
All patients who received the protocol-specified therapy.
|
ALLR17
All patients who had MRD data at the end of Remission Induction
|
|---|---|---|---|---|
|
Mean of CD20 Expression Levels
At Baseline
|
31.10 percentage of CD20 Antigen
Standard Error 9.82
|
39.82 percentage of CD20 Antigen
Standard Error 7.9
|
36.23 percentage of CD20 Antigen
Standard Error 6.11
|
—
|
|
Mean of CD20 Expression Levels
At Block I
|
18.54 percentage of CD20 Antigen
Standard Error 4.93
|
20.10 percentage of CD20 Antigen
Standard Error 3.44
|
19.43 percentage of CD20 Antigen
Standard Error 2.85
|
—
|
SECONDARY outcome
Timeframe: Baseline and at the end of Block I (approximately 5 weeks after the on-study date)Population: Of the 42 patients enrolled, 34 patients had At Baseline data; 42 patients had data At Block I
To estimate median levels of CD20 expression at baseline, during treatment with dexamethasone-containing chemotherapy and following rituximab treatment in Block I of remission induction therapy for relapsed precursor B-cell ALL.
Outcome measures
| Measure |
STANDARD RISK
n=18 Participants
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 Participants
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=42 Participants
All patients who received the protocol-specified therapy.
|
ALLR17
All patients who had MRD data at the end of Remission Induction
|
|---|---|---|---|---|
|
Median CD20 Expression Levels
At Baseline
|
16.40 percentage of CD20 Antigen
Interval 3.3 to 36.8
|
23.13 percentage of CD20 Antigen
Interval 8.75 to 67.25
|
22.0 percentage of CD20 Antigen
Interval 4.3 to 61.2
|
—
|
|
Median CD20 Expression Levels
At Block 1
|
11.83 percentage of CD20 Antigen
Interval 1.5 to 22.15
|
19.58 percentage of CD20 Antigen
Interval 2.6 to 30.67
|
15.58 percentage of CD20 Antigen
Interval 1.5 to 30.13
|
—
|
Adverse Events
STANDARD RISK
Serious events: 1 serious events
Other events: 18 other events
Deaths: 3 deaths
HIGH RISK
Serious events: 0 serious events
Other events: 23 other events
Deaths: 10 deaths
All Patients Enrolled on the Study
Serious events: 1 serious events
Other events: 41 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
STANDARD RISK
n=18 participants at risk
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 participants at risk
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=42 participants at risk
All patients who received the protocol-specified therapy.
|
|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
Other adverse events
| Measure |
STANDARD RISK
n=18 participants at risk
1. Late relapse (≥ 6 months after completion of frontline therapy) AND
2. MRD \< 0.01% at the end of Block II of remission induction therapy.
Provisional standard risk participants (i.e., late relapse) will be re-assigned to High risk if MRD ≥ 0.01% at the end of Block II.
Participants with lymphoma must be in complete remission at the end of Block III.
|
HIGH RISK
n=24 participants at risk
1. Early relapse (on therapy or \< 6 months after completion of frontline therapy), OR
2. Any relapse after hematopoietic stem cell transplant, OR
3. MRD ≥ 0.01% at the end of Block II of remission induction therapy, OR
4. Re-emergence of MRD at any time after attaining negative MRD on ALLR18
|
All Patients Enrolled on the Study
n=42 participants at risk
All patients who received the protocol-specified therapy.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
18/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
91.7%
22/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
95.2%
40/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
94.4%
17/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
95.8%
23/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
95.2%
40/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
18/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
87.5%
21/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
92.9%
39/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
94.4%
17/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
87.5%
21/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
90.5%
38/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
83.3%
15/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
83.3%
20/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
83.3%
35/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
88.9%
16/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
79.2%
19/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
83.3%
35/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
83.3%
15/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
83.3%
20/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
83.3%
35/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
94.4%
17/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
70.8%
17/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
81.0%
34/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
15/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
79.2%
19/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
81.0%
34/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
83.3%
15/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
75.0%
18/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
78.6%
33/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
77.8%
14/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
58.3%
14/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
66.7%
28/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
12/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
54.2%
13/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
59.5%
25/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Constipation
|
61.1%
11/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.8%
11/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
52.4%
22/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
50.0%
9/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
50.0%
12/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
50.0%
21/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
44.4%
8/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
50.0%
12/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
47.6%
20/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Fatigue
|
50.0%
9/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.8%
11/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
47.6%
20/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Vascular disorders
Hypertension
|
38.9%
7/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
50.0%
12/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.2%
19/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
58.3%
14/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.2%
19/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
9/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
41.7%
10/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.2%
19/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Blood bilirubin increased
|
38.9%
7/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.8%
11/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
42.9%
18/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
50.0%
12/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
40.5%
17/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
55.6%
10/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
25.0%
6/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
38.1%
16/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
45.8%
11/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
35.7%
15/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
41.7%
10/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
33.3%
14/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
6/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
33.3%
8/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
33.3%
14/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
37.5%
9/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
33.3%
14/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Enterocolitis infectious
|
33.3%
6/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
33.3%
8/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
33.3%
14/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Sepsis
|
55.6%
10/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
31.0%
13/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Neuralgia
|
38.9%
7/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
20.8%
5/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
28.6%
12/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
6/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
25.0%
6/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
28.6%
12/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Skin infection
|
33.3%
6/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
20.8%
5/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
26.2%
11/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Pain
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
20.8%
5/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
23.8%
10/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Infusion related reaction
|
33.3%
6/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
4/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
23.8%
10/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Immune system disorders
Allergic reaction
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
25.0%
6/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
21.4%
9/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Mucosal infection
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
19.0%
8/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Colitis
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
19.0%
8/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
4/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
19.0%
8/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
4/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
19.0%
8/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Fever
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
4/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
7/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Serum amylase increased
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
7/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
4/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
7/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
7/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
20.8%
5/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Lipase increased
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Vascular disorders
Hypotension
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
GGT increased
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Agitation
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.8%
5/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Rectal pain
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
16.7%
4/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Weight loss
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Chills
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Lung infection
|
22.2%
4/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Eye disorders
Blurred vision
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Catheter related infection
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Anxiety
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Depression
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
9.5%
4/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Acidosis
|
16.7%
3/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Eye disorders
Eye pain
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Vascular disorders
Hematoma
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
6/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
14.3%
6/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Anorectal Infection
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
12.5%
3/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
11.9%
5/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
7.1%
3/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Meningitis
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Encephalopathy
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
11.1%
2/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Bladder infection
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Renal and urinary disorders
Hematuria
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.2%
1/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Encephalitis infection
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Papulopustular rash
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Anal fistula
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Fecal incontinence
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Proctitis
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Injection site reaction
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Immune system disorders
Cytokine release syndrome
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Bone infection
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Infective myositis
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Lip infection
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Otitis externa
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Paronychia
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Investigations
Cardiac troponin T increased
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Alkalosis
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Seizure
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Delirium
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Personality change
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Suicidal ideation
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
0.00%
0/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
2.4%
1/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
General disorders
Edema face
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Infections and infestations
Otitis media
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/18 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
8.3%
2/24 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
4.8%
2/42 • Through one month after therapy completion, approximately 22 months. If participant proceeds to transplant, until the first day of conditioning therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place