Trial Outcomes & Findings for Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies (NCT NCT01760655)
NCT ID: NCT01760655
Last Updated: 2025-10-30
Results Overview
This hypothesis will be rejected if the 95% confidence interval for year DFS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
1 year post hematopoietic stem cell transplant (HSCT)
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Treatment (RIC and allogeneic PBSCT)
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Treatment (RIC and allogeneic PBSCT)
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Death
|
18
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=62 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post hematopoietic stem cell transplant (HSCT)This hypothesis will be rejected if the 95% confidence interval for year DFS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=62 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Disease-free Survival (DFS)
|
.5 proportion of participants
Interval 0.368 to 0.618
|
SECONDARY outcome
Timeframe: 1 year post HSCTWill be analyzed and reported descriptively.
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=62 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
.567 proportion of participants
Interval 0.432 to 0.681
|
SECONDARY outcome
Timeframe: 3 years post HSCTWill be analyzed and reported descriptively.
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=62 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
.479 proportion of participants
Interval 0.347 to 0.599
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Participants surviving to Day +28 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.
CD4 and CD8 values at Day +28. Reported as mean (standard deviation).
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=56 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Immune Reconstitution at Day +28
CD3/4 at Day +28
|
66.9 cells/mm³
Standard Deviation 80.5
|
|
Immune Reconstitution at Day +28
CD3/8 at Day +28
|
109.9 cells/mm³
Standard Deviation 137.4
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Participants surviving to Day +90 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.
CD4 and CD8 values at Day +90. Reported as mean (standard deviation).
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=44 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Immune Reconstitution at Day +90
CD3/4 at Day +90
|
173.7 cells/mm³
Standard Deviation 136.1
|
|
Immune Reconstitution at Day +90
CD3/8 at Day +90
|
343.1 cells/mm³
Standard Deviation 395.4
|
SECONDARY outcome
Timeframe: Up to 1 yearThe incidence and severity of graft-versus-host disease (GVHD) will be analyzed and reported descriptively. Clinical manifestations including skin rash, diarrhea, and liver function test abnormalities will be assessed. GVHD will be staged using established clinical grading systems: acute GVHD will be graded according to the modified Glucksberg criteria, and chronic GVHD will be graded using the NIH consensus criteria. These grading systems classify GVHD severity based on organ involvement and clinical symptoms. Higher stages or grades reflect more severe disease and are considered worse outcomes.
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=59 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Incidence and Degree of Graft Versus Host Disease
Grade 1
|
5 Participants
|
|
Incidence and Degree of Graft Versus Host Disease
Grade 2
|
15 Participants
|
|
Incidence and Degree of Graft Versus Host Disease
Grade 3
|
3 Participants
|
|
Incidence and Degree of Graft Versus Host Disease
Grade 4
|
3 Participants
|
|
Incidence and Degree of Graft Versus Host Disease
Missing/Cannot Assess
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearWill be analyzed and reported descriptively.
Outcome measures
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=60 Participants
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Engraftment Rates
|
59 Participants
|
Adverse Events
Treatment (RIC and allogeneic PBSCT)
Serious events: 30 serious events
Other events: 43 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=62 participants at risk
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 4
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Blood bilirubin increased - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Blood bilirubin increased - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
cholelithiasis - grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Fibrinogen - grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Heart failure - grade 3
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Hypertension - Grade 4
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Hypotension - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - grade 3
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Ileus - grade 3
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Infection - grade 3
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Infection - grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Infection - grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Infusion reaction - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Left ventricular systolic dysfunction - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
multi-organ failure - grade 4
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Opportunistic infection - grade 3
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Pain - Chest wall- grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Pericardial effusion - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
significant mucositis - grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Syncope - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
vasovagal episode - grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
Other adverse events
| Measure |
Treatment (RIC and allogeneic PBSCT)
n=62 participants at risk
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10.
TRANSPLANT: Patients undergo allogeneic PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Fludarabine phosphate: Given IV
Busulfan: Given IV
Total-Body Irradiation: Undergo TBI
Therapeutic Allogeneic Lymphocytes: Undergo DLI
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Abdominal Distention - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Acid Reflux - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 1
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 3
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 4
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Acute Pericatheter Thrombus - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Adenopathy - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Atrial Fibrillation - Grade 2
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Agitation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Agitation - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Agitation - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Alanine Aminotransferase Levels Increased - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Alanine Aminotransferase Levels Increased - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Allergic Rhinitis - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Allergy To Amlodipine - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Allergy To Latex - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Alopecia - Grade 1
|
19.4%
12/62 • Number of events 12 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Altered Mental State - Confusion - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Altered Taste - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Anemia - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Anger - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Anorexia - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Anorexia - Grade 2
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Anxiety - Grade 1
|
19.4%
12/62 • Number of events 12 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Anxiety - Grade 2
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Aortic Aneurysm - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Arthralgias - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Ascites - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Asthma - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Atrial fibrillation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Awakening To Urinate
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Bacteremia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Bacteremia - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Benign Prostatic Hyperplasia - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
BK Cystitis - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Bladder Spasm - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Bleeding At Injection Sites - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Blister - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Blister - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Bloating - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Blood Bilirubin Increased - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Blood Bilirubin Increased - Grade 3
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Blurred Vision - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Blurred Vision - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Body Ache - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Bradycardia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Bruising - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Painful Urination - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Burning/Tearing of Eyes - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Clostridioides Difficile Infection - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Cardiomyopathy - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Colitis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Cellulitis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Change in Appetite/Weight Loss - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Change in Vision - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Chest tightness - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Chills - Grade 1
|
32.3%
20/62 • Number of events 20 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Chills - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Choking - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Chronic Constipation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Chronic Hepatitis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Chronic Kidney Disease - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Chronic Loose Stool - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
COPD - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
CMV Reactivation - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
CMV Reactivation - Grade 3
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Cold Sweats - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Colitis - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Confusion - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Confusion - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Conjunctiva Hemorrhage - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
35.5%
22/62 • Number of events 22 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Coronary Artery Disease - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
17.7%
11/62 • Number of events 11 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Creatinine Increased - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Cytokine Release Syndrome - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Decreased Appetite - Grade 1
|
27.4%
17/62 • Number of events 17 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Decreased Appetite - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Decreased Breath Sounds - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Decreased Concentration - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Decreased Ejection Fraction - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Decreased Urine Output - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Decreased Urine Output - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Decreased White Blood Cell count - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Deep Vein Thrombosis - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Dehydration - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Dehydration - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Delirium - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Depressed Level of Consciousness - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Depression - Grade 1
|
17.7%
11/62 • Number of events 11 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Depression - Grade 2
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Desquamation - Hands - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Diabetes - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Diaphoresis - grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
53.2%
33/62 • Number of events 33 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Diarrhea - Grade 2
|
16.1%
10/62 • Number of events 10 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Diarrhea - Grade 3
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Distension - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Distress - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Diverticulitis - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Dizziness - Grade 1
|
12.9%
8/62 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Dizziness - Grade 2
|
12.9%
8/62 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Dry eyes - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Dry eyes - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Dry Heaving - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Dry Heaving -Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Dry Mouth - Grade 1
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Dry Mouth - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Deep Vein Thrombosis - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Dysgeusia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Dyslipidemia - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Dyslipidemia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Dysphagia - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Dysphagia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on Exertion - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Dysuria - Grade 1
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Dysuria - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Ecchtmosis - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
E-coli Infection - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Eczema - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Edema - Grade 1
|
33.9%
21/62 • Number of events 21 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Edema - Grade 2
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Skin Tears - Elbow - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Elevated Bilirubin - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Elevated Liver Function Tests - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Nervous system disorders
Encephalopathy - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Nervous system disorders
Encephalopathy - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Epistaxis - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Erectile Dysfunction - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Extremity Weakness - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Eye Problems - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Facial Puffiness - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Facial Flushing - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Failure to Thrive - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Fall - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Fall - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Fatigue - Grade 1
|
41.9%
26/62 • Number of events 26 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Fatigue - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Fatigue - Grade 3
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Fever - Grade 1
|
69.4%
43/62 • Number of events 43 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Fever - Grade 2
|
12.9%
8/62 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Fever - Grade 3
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Floaters - grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Folliculitis - grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Gait Disturbance - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Body Aches - Generalized
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
GERD - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
GERD - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
GERO - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Gouty Changes in Digits
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Hallucinations - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Hallucinations - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Headache - Grade 1
|
27.4%
17/62 • Number of events 17 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Headache - Grade 2
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Headache - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Ear and labyrinth disorders
Hearing Loss - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Heart Murmur - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Heartburn - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Hematuria - Grade 1
|
16.1%
10/62 • Number of events 10 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Hematuria - Grade 2
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hemmorhoidal Bleeding - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome - Grade 5
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hemorrhoids - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hemorrhoids - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
HHV-6 Viremia - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Hives - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Hoarseness - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Hyperbilirubin - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hypercalcemia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hyperlipidemia - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hypertension - Grade 1
|
33.9%
21/62 • Number of events 21 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hypertension - Grade 2
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hypertension - Grade 3
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hypervolemia - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hypervolemia - Grade 2
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hyperkalemia - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hypomagnesemia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Hyponatremia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Hypotension - Grade 1
|
27.4%
17/62 • Number of events 17 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hypotension - Grade 2
|
12.9%
8/62 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Hypotension - Grade 4
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Endocrine disorders
Hypothyroidism - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Ileus - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Impaired Skin Integrity - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Increase of Right Atrial Pressure - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Increased Creatinine - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Hepatobiliary disorders
Increased Creatinine - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Indigestion - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Infection (Other) - Grade 3
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Infusion Reaction - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Infusion Reaction - Grade 2
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Insomnia - Grade 1
|
33.9%
21/62 • Number of events 21 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Insomnia - Grade 2
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Jaw Swelling - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Laryngitis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Left Ventricular Dysfunction - grade 3G
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Lethargy - Grade 1
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Lethargy - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Low fibrinogen - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Blood and lymphatic system disorders
Parotitis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Orthostatic Hypotension - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
PACs - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Palpitations - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Palpitations - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Pericardial Effusion - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Pericardial Effusion - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Pericardial Effusion - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Sinus Bradycardia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Supraventricular Tachycardia - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Tachycardia - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Ventricular Tachycardia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Pericardial Effusion - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Tachycardia - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Premature Ventricular Contractions - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Cardiac disorders
Tachycardia - Grade 1
|
33.9%
21/62 • Number of events 21 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Ear and labyrinth disorders
Tinnitus - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Visual Disturbance - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Puffy Eyes -Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Retinal Detachment - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Right Eye Irritation/Tearing - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Scleral Edema - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Eye disorders
Scleral Injection - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
32.3%
20/62 • Number of events 20 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Red Macule on Uvula - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Soreness - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
32.3%
20/62 • Number of events 20 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
16.1%
10/62 • Number of events 10 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Malnutrition - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Gastrointestinal disorders
Vomiting - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Esophageal) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Flank) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Jaw) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Left Extremities) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Left Flank) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Leg) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Lower Quadrant) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Mouth) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Perianal) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Rib) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Toe) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Tooth) - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Painful Swallowing - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pleuritic Pain - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Problems with Balance/ Dizziness - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Arm) - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Foot) - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Gastrointenstinal) - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Rectal) - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Scrotal) - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Myalgias - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Rigors - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Sore Throat - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Shoulder) - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Chest) - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Weakness - Grade 1
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Lightheadedness - Grade 1
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Abdominal) - Grade 1
|
22.6%
14/62 • Number of events 14 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Back) - Grade 1
|
19.4%
12/62 • Number of events 12 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Malaise - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (General) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Hemorrhoids) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Jaw) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Joint/Muscle) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Leg) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Perianal) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Sciatica) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Shoulder) - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Sore Throat - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Weakness - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Abdominal) - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Back) - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Buttock) - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Pain (Chest) - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
General disorders
Weakness - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Nasal Congestion - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Osteoarthritis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Post Nasal Drip - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Rheumatoid Arthritis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Rhinorrhea - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Sinusitis - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Sneezing - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Sinusitis - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Immune system disorders
Sinusitis - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Oral Thrush - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Rhinovirus -Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Pneumonia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Thrush - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Vaginitis - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Periorbital Infection - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Sepsis - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Infections and infestations
Sepsis - Grade 5
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Pericatheter Thrombus - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Injury, poisoning and procedural complications
Skin Wound - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Metabolic Syndrome - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Obesity - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Weight Gain - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Weight Gain - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Metabolism and nutrition disorders
Weight Loss - Grade 1
|
9.7%
6/62 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Thrombus - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Thrombotic Microangiopathy - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Thromboembolic Event - Grade 2
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Vascular disorders
Syncope - Grade 3
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Weakness - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Cramping - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Neuropathy - Grade 1
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Paresthesia - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Singultus - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Tremor - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Neuropathy - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Paresthesia - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Musculoskeletal and connective tissue disorders
Singultus - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Mucositis - Grade 1
|
11.3%
7/62 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Night Sweats - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Peeling lips - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Penile Swelling - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Peripheral Edema - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Rash-Maculo-Papular - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Right Buttock Wound - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Right Heel Skin Tear - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Scalp Sensitivity - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Skin Tear on Scrotum - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Tenosynovitis of Ankle - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Ulcer on Right Ankle - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Vaginal Irritation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Petechiae - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Photophobia - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Scrotal Edema - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
24.2%
15/62 • Number of events 15 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
50.0%
31/62 • Number of events 31 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Mucositis - Grade 2
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Peripheral Edema - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
14.5%
9/62 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Scrotal Edema - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Scrotal Irritation - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Vaginal Hemorrhage
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Mucositis - Grade 3
|
32.3%
20/62 • Number of events 20 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 3
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Skin and subcutaneous tissue disorders
Rectal Hemorrhage - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Sleep Apnea - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Rales - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 1
|
4.8%
3/62 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing - Grade 1
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath - Grade 1
|
22.6%
14/62 • Number of events 14 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 2
|
6.5%
4/62 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thorasic and Mediastinal Disorders (Other) - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea - Grade 4
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Nocturia - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Polyuria - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urgency of Urine - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urinary Frequency - Grade 1
|
16.1%
10/62 • Number of events 10 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urinary Incontinence - Grade 1
|
8.1%
5/62 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urinary Retention - Grade 1
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urinary Tract Infection - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Obstructive Sleep Apnea - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Proteinuria - Grade 2
|
3.2%
2/62 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Renal Insufficiency - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urinary Pain - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Renal and urinary disorders
Urine Output Decreased - Grade 3
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Suicidal Ideation - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Speech or Memory Change - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Racing Thoughts - Grade 1
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Panic Attack - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
|
Psychiatric disorders
Mental Status Change - Grade 2
|
1.6%
1/62 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place