Trial Outcomes & Findings for Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer (NCT NCT00105001)
NCT ID: NCT00105001
Last Updated: 2019-10-30
Results Overview
Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
150 days after transplant
Results posted on
2019-10-30
Participant Flow
Participant milestones
| Measure |
Arm I (MMF and Tacrolimus)
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil \[MMF\] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil \[MMF\] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
Patients receive tacrolimus and Mycophenolate Mofetil \[MMF\] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
69
|
|
Overall Study
COMPLETED
|
70
|
71
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Arm I (MMF and Tacrolimus)
n=70 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=69 Participants
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
60 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
59 participants
n=7 Participants
|
58 participants
n=5 Participants
|
176 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 150 days after transplantPopulation: Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Outcome measures
| Measure |
Arm I (MMF and Tacrolimus)
n=69 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 Participants
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Number of Participants With Grades II-IV Acute GVHD
|
44 Participants
|
34 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 200 days after transplantPopulation: Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
Percentage of NRM as estimated by cumulative incidence methods with competing risks. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
Outcome measures
| Measure |
Arm I (MMF and Tacrolimus)
n=69 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 Participants
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Number of Non-Relapse Mortalities
|
3 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 150 days after transplantPopulation: Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
Outcome measures
| Measure |
Arm I (MMF and Tacrolimus)
n=69 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 Participants
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Number of Participants Utilizing High-Dose Corticosteroids
|
38 Participants
|
35 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 1 Year post-transplantPopulation: Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
Number of patients surviving, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
Outcome measures
| Measure |
Arm I (MMF and Tacrolimus)
n=69 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 Participants
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Number of Participants Surviving Overall
|
48 Participants
|
47 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 2 Years post-transplantPopulation: Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
Number of patients with progression-free survival, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
Outcome measures
| Measure |
Arm I (MMF and Tacrolimus)
n=69 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 Participants
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 Participants
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Number of Participants Surviving Without Progression
|
28 Participants
|
27 Participants
|
26 Participants
|
Adverse Events
Arm I (MMF and Tacrolimus)
Serious events: 9 serious events
Other events: 25 other events
Deaths: 21 deaths
Arm II (MMF and Tacrolimus Alternate Schedule)
Serious events: 8 serious events
Other events: 22 other events
Deaths: 24 deaths
Arm III (MMF, Tacrolimus, and Sirolimus)
Serious events: 7 serious events
Other events: 25 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Arm I (MMF and Tacrolimus)
n=69 participants at risk
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 participants at risk
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 participants at risk
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Vascular disorders
Thrombosis
|
2.9%
2/69 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Injury, poisoning and procedural complications
Severe hemoptysis
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Respiratory infection
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
4.2%
3/71 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Vascular disorders
CNS cerebrovascular ischemia
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Sepsis
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
General disorders
Toxic leukoencephalopathy, infections w/ pneumonia and pyelonephritis
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Hepatobiliary disorders
Hepatic
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Intestinal pneumatosis
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Immune system disorders
GvHD w/ infection
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
General disorders
Multi-organ failure
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Immune system disorders
GVHD
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.9%
2/68 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Hypertension
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
Other adverse events
| Measure |
Arm I (MMF and Tacrolimus)
n=69 participants at risk
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm II (MMF and Tacrolimus Alternate Schedule)
n=71 participants at risk
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
|
Arm III (MMF, Tacrolimus, and Sirolimus)
n=68 participants at risk
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
Fludarabine Phosphate: Given IV
Total-Body Irradiation: Undergo total-body irradiation
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation
Tacrolimus: Given IV or PO
Mycophenolate Mofetil: Given PO
Sirolimus: Given PO
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Nervous system disorders
Ataxia
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Investigations
Blood bilirubin increased
|
2.9%
2/69 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.8%
2/71 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Investigations
Creatinine increased
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
5.9%
4/68 • Number of events 4 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Diarrhea
|
7.2%
5/69 • Number of events 5 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
5.9%
4/68 • Number of events 4 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Duodenal infection
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Enterocolitis
|
2.9%
2/69 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
General disorders
Fatigue
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
General disorders
Fever
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
4.2%
3/71 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.8%
2/71 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Nervous system disorders
Headache
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.9%
2/68 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Heart failure
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Vascular disorders
Hematoma
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Vascular disorders
Hypertension
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Vascular disorders
Hypotension
|
1.4%
1/69 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.2%
5/69 • Number of events 5 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
11.3%
8/71 • Number of events 9 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
5.9%
4/68 • Number of events 4 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Lung infection
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (Cervical disk herniation)
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify (Pain, NOS)
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
4.4%
3/68 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Investigations
Neutrophil count decreased
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
4.2%
3/71 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Investigations
Platelet count decreased
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.8%
2/71 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.9%
2/68 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Nervous system disorders
Psychosis
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify (Pulmonary, NOS)
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Nervous system disorders
Seizure
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Sepsis
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Infections and infestations
Skin infection
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Nervous system disorders
Syncope
|
2.9%
2/69 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.9%
2/68 • Number of events 3 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Vascular disorders
Thromboembolic event
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
2.9%
2/68 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.4%
1/69 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Nervous system disorders
Tremor
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.9%
2/69 • Number of events 2 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/68 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
0.00%
0/71 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
|
Investigations
White blood cell decreased
|
0.00%
0/69 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.4%
1/71 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
1.5%
1/68 • Number of events 1 • AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
|
Additional Information
Dr. Brenda M. Sandmaier
Fred Hutchinson Cancer Research Center
Phone: (206) 667-4961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place