Trial Outcomes & Findings for Abatacept as GVHD Prophylaxis Phase 2 (NCT NCT01743131)
NCT ID: NCT01743131
Last Updated: 2025-12-11
Results Overview
The primary analysis will consist of estimating the cumulative incidence of severe aGVHD at day +100 post-transplant in the standard and investigational study arms. All registered patients will be considered for this analysis. The primary null hypothesis of the study is that there will be no difference in severe aGVHD between the investigational and standard GVHD prophylaxis arms. The primary outcome will be assessed in a final analysis to be performed after the last enrolled patient has been followed for 100 days post-transplant. The cumulative incidence and confidence interval will be calculated. The cumulative incidence will be compared between treatment arms using logistic regression models. Relapse will be considered a competing risk for aGVHD to negate the effect of measures, such as withdrawal of immune suppression and donor-lymphocyte infusion, often used in response to relapse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
First 100 days after transplant
Results posted on
2025-12-11
Participant Flow
All 7/8 patients are compared to a historical control group (127 controls) from the Center for International Blood and Marrow Research (CIBMTR) registry. One 7/8 patient was randomized to receive placebo and was removed from data analysis. 186 patients were enrolled and 185 were included in analysis (313 - 127 -1 = 185).
Participant milestones
| Measure |
Matched Unrelated Donor - Randomized to Abatacept
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched Unrelated Donor - Randomized to Placebo
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched Unrelated Donor - Received Abatacept
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched Unrelated Donor - Received Placebo
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched Unrelated Donor - CIBMTR Control (No ATG)
CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
69
|
43
|
1
|
127
|
|
Overall Study
Not included in analysis
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
73
|
69
|
43
|
1
|
127
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abatacept as GVHD Prophylaxis Phase 2
Baseline characteristics by cohort
| Measure |
Matched Unrelated Donor - Randomized to Abatacept
n=73 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched Unrelated Donor - Randomized to Placebo
n=69 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched Unrelated Donor - Received Abatacept
n=43 Participants
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched Unrelated Donor - CIBMTR Control (No ATG)
n=127 Participants
CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 years
n=9 Participants
|
41 years
n=6 Participants
|
39.0 years
n=9 Participants
|
45 years
n=205 Participants
|
44.2 years
n=16 Participants
|
|
Age, Customized
Age > 21 year
|
57 number of patients
n=9 Participants
|
52 number of patients
n=6 Participants
|
25 number of patients
n=9 Participants
|
88 number of patients
n=205 Participants
|
222 number of patients
n=16 Participants
|
|
Sex/Gender, Customized
Male/Male
|
30 number of patients
n=9 Participants
|
24 number of patients
n=6 Participants
|
16 number of patients
n=9 Participants
|
36 number of patients
n=205 Participants
|
106 number of patients
n=16 Participants
|
|
Sex/Gender, Customized
Male/Female
|
14 number of patients
n=9 Participants
|
17 number of patients
n=6 Participants
|
11 number of patients
n=9 Participants
|
15 number of patients
n=205 Participants
|
57 number of patients
n=16 Participants
|
|
Sex/Gender, Customized
Female/Male
|
11 number of patients
n=9 Participants
|
13 number of patients
n=6 Participants
|
9 number of patients
n=9 Participants
|
24 number of patients
n=205 Participants
|
57 number of patients
n=16 Participants
|
|
Sex/Gender, Customized
Female/Female
|
18 number of patients
n=9 Participants
|
15 number of patients
n=6 Participants
|
7 number of patients
n=9 Participants
|
17 number of patients
n=205 Participants
|
57 number of patients
n=16 Participants
|
|
Sex/Gender, Customized
unknown
|
0 number of patients
n=9 Participants
|
0 number of patients
n=6 Participants
|
0 number of patients
n=9 Participants
|
35 number of patients
n=205 Participants
|
35 number of patients
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
13 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=9 Participants
|
66 Participants
n=6 Participants
|
36 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
170 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
127 Participants
n=205 Participants
|
129 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
12 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
16 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=9 Participants
|
60 Participants
n=6 Participants
|
31 Participants
n=9 Participants
|
105 Participants
n=205 Participants
|
259 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
3 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
14 Participants
n=205 Participants
|
20 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=9 Participants
|
69 participants
n=6 Participants
|
43 participants
n=9 Participants
|
127 participants
n=205 Participants
|
312 participants
n=16 Participants
|
|
Disease
Acute Myeloid Leukemia
|
30 participants
n=9 Participants
|
22 participants
n=6 Participants
|
15 participants
n=9 Participants
|
54 participants
n=205 Participants
|
123 participants
n=16 Participants
|
|
Disease
Acute Lymphocytic Leukemia
|
24 participants
n=9 Participants
|
23 participants
n=6 Participants
|
9 participants
n=9 Participants
|
26 participants
n=205 Participants
|
82 participants
n=16 Participants
|
|
Disease
Myelodysplastic Syndrome
|
15 participants
n=9 Participants
|
12 participants
n=6 Participants
|
11 participants
n=9 Participants
|
42 participants
n=205 Participants
|
80 participants
n=16 Participants
|
|
Disease
Chronic Myeloid Leukemia
|
1 participants
n=9 Participants
|
5 participants
n=6 Participants
|
4 participants
n=9 Participants
|
4 participants
n=205 Participants
|
14 participants
n=16 Participants
|
|
Disease
Hodgkin Lymphoma
|
1 participants
n=9 Participants
|
1 participants
n=6 Participants
|
1 participants
n=9 Participants
|
1 participants
n=205 Participants
|
4 participants
n=16 Participants
|
|
Disease
Other
|
2 participants
n=9 Participants
|
6 participants
n=6 Participants
|
3 participants
n=9 Participants
|
0 participants
n=205 Participants
|
11 participants
n=16 Participants
|
|
Karnofsky/Lansky Performance Status
|
52 participants
n=9 Participants
|
52 participants
n=6 Participants
|
32 participants
n=9 Participants
|
95 participants
n=205 Participants
|
231 participants
n=16 Participants
|
|
Conditioning Regimen
Busulfan/Cyclophosphamide
|
28 participants
n=9 Participants
|
21 participants
n=6 Participants
|
13 participants
n=9 Participants
|
28 participants
n=205 Participants
|
90 participants
n=16 Participants
|
|
Conditioning Regimen
TBI/Cyclophosphamide
|
20 participants
n=9 Participants
|
26 participants
n=6 Participants
|
11 participants
n=9 Participants
|
37 participants
n=205 Participants
|
94 participants
n=16 Participants
|
|
Conditioning Regimen
Fludarabine/Melphalan
|
18 participants
n=9 Participants
|
20 participants
n=6 Participants
|
11 participants
n=9 Participants
|
15 participants
n=205 Participants
|
64 participants
n=16 Participants
|
|
Conditioning Regimen
Busulfan/Fludarabine
|
7 participants
n=9 Participants
|
2 participants
n=6 Participants
|
8 participants
n=9 Participants
|
38 participants
n=205 Participants
|
55 participants
n=16 Participants
|
|
Conditioning Regimen
Other
|
0 participants
n=9 Participants
|
0 participants
n=6 Participants
|
0 participants
n=9 Participants
|
9 participants
n=205 Participants
|
9 participants
n=16 Participants
|
|
Graft Type
Peripheral Blood
|
40 participants
n=9 Participants
|
43 participants
n=6 Participants
|
22 participants
n=9 Participants
|
79 participants
n=205 Participants
|
184 participants
n=16 Participants
|
|
Graft Type
Bone Marrow
|
33 participants
n=9 Participants
|
26 participants
n=6 Participants
|
21 participants
n=9 Participants
|
48 participants
n=205 Participants
|
128 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: First 100 days after transplantThe primary analysis will consist of estimating the cumulative incidence of severe aGVHD at day +100 post-transplant in the standard and investigational study arms. All registered patients will be considered for this analysis. The primary null hypothesis of the study is that there will be no difference in severe aGVHD between the investigational and standard GVHD prophylaxis arms. The primary outcome will be assessed in a final analysis to be performed after the last enrolled patient has been followed for 100 days post-transplant. The cumulative incidence and confidence interval will be calculated. The cumulative incidence will be compared between treatment arms using logistic regression models. Relapse will be considered a competing risk for aGVHD to negate the effect of measures, such as withdrawal of immune suppression and donor-lymphocyte infusion, often used in response to relapse.
Outcome measures
| Measure |
Matched unrelated donor - randomized to abatacept
n=73 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched unrelated donor - randomized to placebo
n=69 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - received abatacept
n=43 Participants
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - CIBMTR Control (No ATG)
n=127 Participants
CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
|---|---|---|---|---|
|
Percentage of Participants With Cumulative Incidence of Severe aGVHD at Day +100 Post-transplant
|
6.8 percentage of participants
Interval 2.5 to 14.2
|
14.8 percentage of participants
Interval 7.5 to 24.3
|
2.2 percentage of participants
Interval 0.2 to 10.7
|
30.2 percentage of participants
Interval 22.4 to 38.3
|
SECONDARY outcome
Timeframe: 5 years post-transplantPopulation: Secondary outcomes data is not available for the historical control arm "Mismatched unrelated donor - CIBMTR Control (No ATG)'.
Clinical endpoints analyzed at 5 years include relapse, non-relapse mortality (NRM), acute GVHD grade III-IV, chronic GVHD requiring systemic therapy (ST-requiring cGVHD), overall survival (OS), relapse-free survival (RFS), and the composite endpoint of acute GVHD grades III-IV-free, systemic therapy-requiring chronic GVHD-free, relapse-free survival (GRFS).
Outcome measures
| Measure |
Matched unrelated donor - randomized to abatacept
n=69 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched unrelated donor - randomized to placebo
n=73 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - received abatacept
n=43 Participants
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - CIBMTR Control (No ATG)
CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
|---|---|---|---|---|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
Non-Relapse Mortality
|
23.7 Percentage of participants
Interval 14.3 to 34.5
|
18.5 Percentage of participants
Interval 10.3 to 28.5
|
18.6 Percentage of participants
Interval 8.6 to 31.6
|
—
|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
Relapse
|
24.6 Percentage of participants
Interval 15.2 to 35.3
|
23.4 Percentage of participants
Interval 14.4 to 33.8
|
11.6 Percentage of participants
Interval 4.2 to 23.2
|
—
|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
chronic GVHD requiring systemic therapy
|
47.8 Percentage of participants
Interval 33.9 to 60.4
|
58.6 Percentage of participants
Interval 45.2 to 69.8
|
76.1 Percentage of participants
Interval 58.6 to 86.9
|
—
|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
Overall survival
|
54.3 Percentage of participants
Interval 43.6 to 67.7
|
61.0 Percentage of participants
Interval 50.3 to 73.9
|
72.1 Percentage of participants
Interval 59.9 to 86.8
|
—
|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
Relapse-free survival
|
51.7 Percentage of participants
Interval 41.0 to 65.1
|
58.1 Percentage of participants
Interval 47.6 to 70.8
|
69.8 Percentage of participants
Interval 57.3 to 84.9
|
—
|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
GRFS composite endpoint
|
26.1 Percentage of participants
Interval 17.5 to 38.8
|
21.9 Percentage of participants
Interval 4.22 to 33.8
|
16.3 Percentage of participants
Interval 8.3 to 32.1
|
—
|
|
A Cumulative Incidence of Relapse, Non-relapse Mortality, Acute GVHD Grade III-IV, cGVHD Requiring Systemic Therapy, Overall Survival and GRFS Will be Computed.
Acute GVHD grade III-IV
|
14.8 Percentage of participants
Interval 7.5 to 24.3
|
10.0 Percentage of participants
Interval 4.3 to 18.3
|
2.3 Percentage of participants
Interval 0.2 to 10.7
|
—
|
SECONDARY outcome
Timeframe: First 180 days after transplantTo compare severe (Grade III-IV) aGVHD free survival (GFS) up to Day 180 post-transplantation between the abatacelpt + standard GVHD prophylaxis and standard GVHD prophylaxis regimen. The aGVHD events in this definition of GFS are the adjudicated grade (III-IV) aGVHD events. (This is a pre-determined endpoint for the 8/8 cohort and a retrospective endpoint for the 7/8 cohort).
Outcome measures
| Measure |
Matched unrelated donor - randomized to abatacept
n=73 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched unrelated donor - randomized to placebo
n=69 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - received abatacept
n=43 Participants
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - CIBMTR Control (No ATG)
n=127 Participants
CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
|---|---|---|---|---|
|
Percentage of Participants With Severe (Grade III-IV) aGVHD Free Survival (GFS) up to Day +180
|
93.2 percentage of participants
Interval 84.3 to 97.1
|
82 percentage of participants
Interval 70.5 to 89.4
|
97.7 percentage of participants
Interval 84.6 to 99.7
|
58.7 percentage of participants
Interval 49.4 to 66.8
|
SECONDARY outcome
Timeframe: First 180 days after transplantTo compare the cumulative incidence of severe (grade III-IV) aGVHD (based on adjudicated aGVHD events) up to Day 180 post-transplant between the abatacept + standard GVHD prophylaxis and standard GVHD prophylaxis regimen. (This is a pre-determined endpoint for the 8/8 cohort and a retrospective endpoint for the 7/8 cohort).
Outcome measures
| Measure |
Matched unrelated donor - randomized to abatacept
n=73 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched unrelated donor - randomized to placebo
n=69 Participants
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - received abatacept
n=43 Participants
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched unrelated donor - CIBMTR Control (No ATG)
n=127 Participants
CIBMTR Control cohort - Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis of calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
|---|---|---|---|---|
|
Rate of Severe (Grade III-IV) aGVHD (Based on Adjudicated aGVHD Events) up to Day +180
|
6.8 percentage of participants
Interval 2.5 to 14.2
|
14.8 percentage of participants
Interval 7.5 to 24.3
|
2.2 percentage of participants
Interval 0.2 to 10.7
|
32.1 percentage of participants
Interval 24.0 to 40.4
|
Adverse Events
Matched Unrelated Donor - Randomized to Abatacept
Serious events: 51 serious events
Other events: 0 other events
Deaths: 19 deaths
Matched Unrelated Donor - Randomized to Placebo
Serious events: 46 serious events
Other events: 0 other events
Deaths: 24 deaths
Mismatched Unrelated Donor - Received Abatacept
Serious events: 30 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Matched Unrelated Donor - Randomized to Abatacept
n=73 participants at risk
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Matched Unrelated Donor - Randomized to Placebo
n=69 participants at risk
A randomized, double-blind placebo-controlled cohort of patients undergoing 8/8 HLA matched unrelated donor transplant for hematologic malignancy who were randomized to standard GVHD prophylaxis and placebo (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
Mismatched Unrelated Donor - Received Abatacept
n=43 participants at risk
Patients undergoing 7/8 HLA mismatched unrelated donor transplant for hematologic malignancy who received standard GVHD prophylaxis and abatacept (Day -1, Day +5, Day +14, Day +28 post-transplant).
Standard GVHD prophylaxis is calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Blood and lymphatic system disorders
post-transplant lymphoproliferative disease
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
atrial fibrilation
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.3%
3/69 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
chest pain
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
heart failure
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
myocartial infarction
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
restrictive cardiomyopathy
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Cardiac disorders
supraventricular tachycardia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.3%
3/69 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
Acute GVHD of the skin
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
colitis
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
diarrhea
|
4.1%
3/73 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
duodenal hemorrhage
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
enteritis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
other - graft versus host disease
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
Gastrointestinal GVHD
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
graft versus host disease
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
jejunal hemorrhage
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
lower gastrointestinal hemorrhage
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.3%
3/69 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
mucositis oral
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
nausea
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
pyloric ulcer
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
typhitis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrhage
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
chills
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
edema limbs
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
fever
|
5.5%
4/73 • Number of events 8 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
8.7%
6/69 • Number of events 6 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
18.6%
8/43 • Number of events 10 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
infusion related reaction
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
intermittent fever
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
multi organ failure
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.7%
2/43 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
pain
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Hepatobiliary disorders
choledocholithiasis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Hepatobiliary disorders
liver graft versus host disease
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Hepatobiliary disorders
veno-occlusive disease
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Immune system disorders
cytokine release syndrome
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
acute appendicitis
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
bacteremia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
conjunctivitis infective
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
devise infection
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
syncope
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
encephalitis infection
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
enterocolitis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
enterocolitis, infectious
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
epstein-barr virus infection reactivation
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
eye infection
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
lung infection
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.7%
2/43 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
meningitis
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
sepsis
|
4.1%
3/73 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
8.7%
6/69 • Number of events 6 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.7%
2/43 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
skin infection
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
viral pneumonia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Infections and infestations
viremia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Investigations
elevated creatinine
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Investigations
platelet count decreased
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Metabolism and nutrition disorders
anorexia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Musculoskeletal and connective tissue disorders
septic arthritis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
myelodisplastic syndrome
|
1.4%
1/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
encephalopathy
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
4.3%
3/69 • Number of events 4 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
headache
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
intracranial hemorrhage
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
reversible posterior leukoencephalopathy syndrome
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
seizure
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
stroke
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Nervous system disorders
transient ischemic attack
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Psychiatric disorders
altered mental status
|
4.1%
3/73 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Psychiatric disorders
confusion
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Psychiatric disorders
delirium
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Psychiatric disorders
psychiatric disorders - altered mental status
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Renal and urinary disorders
acute kidney injury
|
4.1%
3/73 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Renal and urinary disorders
hemorrhagic cystitis
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
adult respiratory distress syndrome
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
4.1%
3/73 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
obstrictive sleep apnea
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
5.5%
4/73 • Number of events 4 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
5.8%
4/69 • Number of events 4 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
7.0%
3/43 • Number of events 3 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic colon adenocarcinoma
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Skin and subcutaneous tissue disorders
skin graft versus host disease
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Vascular disorders
hypertension
|
1.4%
1/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Vascular disorders
hematoma
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
1.4%
1/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Vascular disorders
hypotension
|
2.7%
2/73 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.9%
2/69 • Number of events 2 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Vascular disorders
thromboembolic event
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
Immune system disorders
allergic reaction
|
0.00%
0/73 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
0.00%
0/69 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
2.3%
1/43 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
|
General disorders
Primary disease relapse
|
20.5%
15/73 • Number of events 15 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
29.0%
20/69 • Number of events 20 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
16.3%
7/43 • Number of events 7 • Deaths were monitored for 5 years post-transplant. Adverse Events were monitored for 5 years post-transplant and reported when the event(s) met repoting criteria outlined in the study protocol.
For the purposes of this study, PTLD, non-engraftment, graft rejection and secondary graft failure were considered SAEs regardless of their impact on the patient's condition. Adverse Events were not collected for the CIBMTR Control group (127 patients).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place