Trial Outcomes & Findings for Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies (NCT NCT02566304)
NCT ID: NCT02566304
Last Updated: 2025-04-24
Results Overview
OS will be estimated using Kaplan-Meier curves. The 1-year OS rate and corresponding 95% confidence interval will be estimated from the Kaplan-Meier curve for the OS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
At 1 year post HSCT
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
RIC HSCT, GVHD Prophylaxis
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
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
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 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
|
0 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 year post HSCTOS will be estimated using Kaplan-Meier curves. The 1-year OS rate and corresponding 95% confidence interval will be estimated from the Kaplan-Meier curve for the OS.
Outcome measures
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS)
|
74 percentage of participants
Interval 54.0 to 86.0
|
SECONDARY outcome
Timeframe: At 1 year post HSCTWill be reported descriptively. RRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
Outcome measures
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Relapse Related Mortality (RRM)
|
13 percentage of participants
Interval 4.0 to 28.0
|
SECONDARY outcome
Timeframe: At 1 year post HSCTWill be reported descriptively. NRM may also be estimated using Kaplan Meier curves and/or cumulative incidence analyses.
Outcome measures
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Non-Relapse Mortality (NRM)
|
16 percentage of participants
Interval 6.0 to 31.0
|
SECONDARY outcome
Timeframe: Up to 1 year post HSCTWill be reported descriptively
Outcome measures
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Incidence and Severity of GVHD
|
27 percentage of participants
Interval 13.0 to 43.0
|
SECONDARY outcome
Timeframe: Up to 1 year post HSCTWill be reported descriptively
Outcome measures
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Engraftment Rates
|
97 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 1 year post HSCTLymphoid reconstitution will be evaluated monthly to every other month during the first year post HSCT and will be reported descriptively.
Outcome measures
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 Participants
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Lymphoid Reconstitution
|
10 percentage of participants
Interval 3.0 to 25.0
|
Adverse Events
RIC HSCT, GVHD Prophylaxis
Serious events: 10 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 participants at risk
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
ALT increased
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Bilirubin increased
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Cardiac Arrest
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Cellulitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Cholecystitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Cognitive disturbance
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Deliurm
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Depressed level of Consciousness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Ejection Fraction decreased
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Fever
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
Hepatobiliary disorder
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
28.6%
10/35 • Number of events 15 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infection & Infestations- Other fever
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
Lung Infection
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Nervous System disorder- Aphasia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Sepsis
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
SVT
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Syncope
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
Other adverse events
| Measure |
RIC HSCT, GVHD Prophylaxis
n=35 participants at risk
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6.
TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Fludarabine: Given IV
Total-Body Irradiation: Undergo TBI
T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI
Cyclophosphamide: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant
Tacrolimus: Given PO
Mycophenolate mofetil: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Injury, poisoning and procedural complications
Wound-top of head
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
Wound of Groin
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
Wound on buttock
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
5/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Metabolism and nutrition disorders
Weight loss
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Weakness
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
VRE
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Vomiting
|
51.4%
18/35 • Number of events 31 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Volume overload
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Vaginal cysts
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
UTI-VRE
|
2.9%
1/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Urine incontinence
|
25.7%
9/35 • Number of events 13 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
urinary retention
|
22.9%
8/35 • Number of events 9 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Urinary frequency
|
34.3%
12/35 • Number of events 14 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Trouble sleeping
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
tooth pain
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Tachycardia
|
20.0%
7/35 • Number of events 11 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Tachypnea
|
14.3%
5/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Stiff neck
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Sleep apnea
|
5.7%
2/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Tinea Cruis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Ear and labyrinth disorders
Tinnitus
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Vision changes
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Urinary tract pain
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Urinary Tract Infection
|
17.1%
6/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Typhlitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Vitamin K deficiency
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Trouble swallowing
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Unexpected weight change
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Tremor
|
17.1%
6/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Thromboembolic event
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Thrush
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Throat pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
sleep apnea
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
tissue disorders- other, skin tear
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders-other, sacrum sore
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- other, erythema
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- other, keratosis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders- other, Folliculitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other excoriation
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Syncope
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Somnolence
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin- Ashen color
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
14.3%
5/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
sinus tachycardia
|
48.6%
17/35 • Number of events 30 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Sinus Bradycardia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Sexual dysfunction
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
sore throat
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin peeling
|
5.7%
2/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
subconjunctiva hemorrhage
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
scalp pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Reproductive system and breast disorders
Scrotal pain
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Reproductive system and breast disorders
Scrotal Edema
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
scleral disorder
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Right arm swelling
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash
|
48.6%
17/35 • Number of events 23 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders- other, rales
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
34.3%
12/35 • Number of events 19 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Rigors
|
2.9%
1/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Renal and urinary disorders- other, dysuria
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Rectal pain
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders- other, nasopharyngeal bleed
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Renal and Urinary disorders- hemorrhagic cystitis due to BK virus
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders- other, scrotal edema
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Renal and urinary disorders- other, decreased urine output
|
28.6%
10/35 • Number of events 12 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other, tachypnea
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Renal and Urinary disorders- other, difficulty urinating
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Premature Ventricular Contractions
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Pulmonary edema
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
28.6%
10/35 • Number of events 11 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusions
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Pericardial effusion
|
17.1%
6/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Vasovagal reaction
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- other, diaphoretic
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders- other, pale
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
viral conjunctivitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Unspecified eye problem
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
taste change
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
sleep disturbance
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders- other, Pallor
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
sinus headache
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Paresthesia pain
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Palpitations
|
5.7%
2/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
10/35 • Number of events 16 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Pain - general
|
28.6%
10/35 • Number of events 12 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.7%
2/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Pneumonitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Parotiditis
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Physical deconditioning
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Psychiatric disorders- other, decreased concentration
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Pericarditis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Peripheral neuropathy
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
peripheral edema
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
patchy spots on tongue
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Pruritic raised erythematous rash
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
polyuria
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Odynophagia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
Night sweats
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Neuro-weakness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.4%
4/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Nausea
|
57.1%
20/35 • Number of events 31 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Non- cardiac chest pain
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Nervous System Disorders- other, Altered MS with Aphasia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (in cyss and polyps)- other, bump on left arm
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Nosebleeds
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Nocturia
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
5/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
60.0%
21/35 • Number of events 22 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
MRSA - skin lesion
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder- other, Charlie HOrse
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other, unsteadiness on feet
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Malaise
|
11.4%
4/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Memory impairment
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders- other, physical deconditioning
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness in extremity
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders- electrolyte disturbances
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Mouth Sores
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
Lung Infection
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Endocrine disorders
Lump on right forearm
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Loss of smell/taste
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Loose Stools
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Lightheadedness
|
8.6%
3/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Lethargy/Fatigue
|
8.6%
3/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
Left pericatheter thrombus
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
LE edema
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
Left Axilla swelling
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Itching
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Irregular heart ryhythm
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Insomnia
|
42.9%
15/35 • Number of events 19 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infusion Related Reaction - rigors
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Infusion related reaction- Hypertension
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Infusion related reaction- headache
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infusion related reaction- chills
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
infusion related reaction
|
34.3%
12/35 • Number of events 13 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infection and Infestations- other (fever)
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Indigestion
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
Increased LFT's
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
infections and infestations- other, CMV reactivation
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infections and infestations- other, cellulitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
increased creatinine
|
17.1%
6/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Iron overload
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications- other, wounds
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications- other, scrotal bleeding
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications- other, pressure ulcer
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications- other, parotitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications- other, GI bleeding
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Infusion related reaction- hypotension
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infections and infestations- other, HHV-6
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infections and infestations- other, CMV Viremia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Infections and infestations- other, bacteremia
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications- other ecchymosis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
infections and infestations- other, epididmoorchitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
infections and infestations- other, covid-19
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
intermittent hyperglycemia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
intermittent headache
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
intermittent fatigue
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
intermittent dizziness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Reproductive system and breast disorders
Vaginal Pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.9%
1/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Phantom pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Oral Pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Metabolism and nutrition disorders
Metabolism and nutritional disorders- other, vitamin D deficiency
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
54.3%
19/35 • Number of events 25 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Hypotension
|
51.4%
18/35 • Number of events 35 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Vascular disorders
Hypertension
|
34.3%
12/35 • Number of events 16 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Endocrine disorders
Hyperkalemia
|
20.0%
7/35 • Number of events 7 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Reproductive system and breast disorders
Hot flashes
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Immune system disorders
Hive
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Headache
|
37.1%
13/35 • Number of events 27 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Hallucinations
|
17.1%
6/35 • Number of events 8 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Hiccups
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hypomagnesemia
|
17.1%
6/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hypokalemia
|
17.1%
6/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hyperglycemia
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hypothermia
|
8.6%
3/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hypophosphatemia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hyponatremia
|
11.4%
4/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hypernatremia
|
14.3%
5/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Heel pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Hyperhidrosis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Hoarsness
|
2.9%
1/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
hemorrhoids
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
Hyperphosphatemia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
GERD
|
20.0%
7/35 • Number of events 7 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
General Disorders and administration site conditions - other Diaphoresis
|
2.9%
1/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
General disorders and administration site conditions- other, generalized aches
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other, Oral ulcer
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Gait Disturbance
|
20.0%
7/35 • Number of events 8 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
General disorders and administration site conditions- other fluid overload
|
22.9%
8/35 • Number of events 10 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Gatrointestinal disorders- other oral blister
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other, "itchy" mouth
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
General disorders and administration site disorders- other, night sweats
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
general disorders and administration site conditions- other, bleeding event
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
gastrointestinal pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
gastrointestinal disorders- other, Perirectal irritation
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
gastrointestinal disorders- other, pain at PEG site
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
gastrointestinal disorders- other, hematochezia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other, tongue coating
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Generalized itching
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Hypervolemia
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Foot and Leg pain
|
2.9%
1/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Flatulence
|
31.4%
11/35 • Number of events 12 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
Fever
|
88.6%
31/35 • Number of events 63 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Fatigue
|
82.9%
29/35 • Number of events 34 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
Fall
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Flushing
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Floaters
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
Epistaxis
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Enterocolitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
Elevated total bilirubin level
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
Elevated creatinine
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Ejection fraction decreased
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Edema
|
48.6%
17/35 • Number of events 25 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Ear and labyrinth disorders
Ear pain
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Eye disorders - other, blind in right eye
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Eye infection
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Eye disorders, other Diplopia
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Reproductive system and breast disorders
Excoriation - scrotum
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Ear and labyrinth disorders
ear and labyrinth disorders- other, ear fullness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
eye disorders- other, farsightedness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Esophagitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
Dysuria
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
48.6%
17/35 • Number of events 23 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
DVT
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
10/35 • Number of events 12 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Dry Eyes
|
11.4%
4/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Eye disorders
Double vision
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Diarrhea
|
91.4%
32/35 • Number of events 59 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Distended stomach
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Injury, poisoning and procedural complications
Discomfort at foley site
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Depression
|
31.4%
11/35 • Number of events 13 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Metabolism and nutrition disorders
decreased PO intake
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Metabolism and nutrition disorders
decreased appetite
|
5.7%
2/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Nervous system disorders
Dizziness
|
28.6%
10/35 • Number of events 14 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Delirium
|
17.1%
6/35 • Number of events 7 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
Diaphoresis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
5/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Dysgeusia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Distention
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
deconditioning
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
dehyrdration
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
37.1%
13/35 • Number of events 18 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
cystitis noninfective
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
constipation
|
42.9%
15/35 • Number of events 20 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Confusion
|
25.7%
9/35 • Number of events 14 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
CMV reactivation
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
chills
|
34.3%
12/35 • Number of events 16 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
chest tightness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
chest pain
|
14.3%
5/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Cardio disorders- other, murmur
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
crushingoid
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
cognitive disturbance
|
11.4%
4/35 • Number of events 4 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
crackles at lung bases
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
cholelithiasis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Infections and infestations
cytomegalovirus viremia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
burning sensation
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Hepatobiliary disorders
blood bilirubin increased
|
37.1%
13/35 • Number of events 22 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
bladder pressure
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
bibasilar atelectasis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
back pain and stiffness
|
34.3%
12/35 • Number of events 13 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
buttocks pain
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
bruising
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
bradycardia
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
bloating
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Blood and lymphatic system disorders
blood and lymphatic system disorders- other
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
bullous dermatitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
blood blister
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
bone pain
|
2.9%
1/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
bilateral pam itching
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
bilateral leg cramp
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
bilateral edema
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
awakening to urinate
|
8.6%
3/35 • Number of events 3 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
atrial fibrillation
|
5.7%
2/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Anxiety
|
17.1%
6/35 • Number of events 7 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.4%
11/35 • Number of events 11 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Psychiatric disorders
Agitated/ Irritable
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Acidy mouth
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Achiness
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Abrasion
|
5.7%
2/35 • Number of events 2 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
Abdominal pain
|
54.3%
19/35 • Number of events 28 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
aspartate aminotransferase increased
|
11.4%
4/35 • Number of events 5 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
20.0%
7/35 • Number of events 7 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
alkaline phosphate increased
|
14.3%
5/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
abdominal distention
|
20.0%
7/35 • Number of events 8 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
anorexia
|
57.1%
20/35 • Number of events 22 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Investigations
alanine aminotransferase increased
|
11.4%
4/35 • Number of events 6 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Renal and urinary disorders
acute kidney injury
|
28.6%
10/35 • Number of events 13 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
aspiration
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
Atrial Flutter
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
ascites
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
General disorders
altered taste
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Cardiac disorders
atrial fibrillation RVR
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
acute diverticulitis
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
|
Gastrointestinal disorders
abdominal discomfort
|
2.9%
1/35 • Number of events 1 • Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
CTCAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place