Trial Outcomes & Findings for A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies (NCT NCT01384513)

Last Updated: 2026-04-15

Results Overview

The primary null hypothesis is that 2 year OS rate is at most 35%. This hypothesis will be rejected if the 95% confidence interval for year OS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

At 2 years

Results posted on

2026-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Allogeneic PBSCT) REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Overall Study STARTED	40
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Allogeneic PBSCT) REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Overall Study Death	15

Baseline Characteristics

A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Age, Categorical <=18 years	0 Participants n=193 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=193 Participants
Age, Categorical >=65 years	23 Participants n=193 Participants
Sex: Female, Male Female	17 Participants n=193 Participants
Sex: Female, Male Male	23 Participants n=193 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=193 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=193 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	2 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	7 Participants n=193 Participants
Race (NIH/OMB) White	31 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants

PRIMARY outcome

Timeframe: At 2 years

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Overall Survival (OS) in Patients With Haploidentical Family Donors With Hematological Malignancies in Morphological or Radiographic Remission or With Chemosensitive, Indolent Diseases Overall survival at 2 years	31 Participants
Overall Survival (OS) in Patients With Haploidentical Family Donors With Hematological Malignancies in Morphological or Radiographic Remission or With Chemosensitive, Indolent Diseases expired prior to 2 year survival window	9 Participants

SECONDARY outcome

Timeframe: At 2 years

To compare the treatment related mortality rate (TRM) for patients treated on this study to the historical TRM rates of patients undergoing reduced intensity conditioning (RIC) matched-sibling hematopoietic stem cell transplant (HSCT) as reported in the literature

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Treatment Related Mortality (TRM)	10 percentage of participants Interval 3.1 to 21.7

SECONDARY outcome

Timeframe: Assessed up to 2 years

The estimates of incidence rates will be presented with corresponding 95% confidence intervals using the exact method

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Number of Participants With Acute G2-4 and/or Chronic Moderate or Severe GVHD Acute G2-4 GVHD	39 percentage of participants Interval 25.0 to 56.0
Number of Participants With Acute G2-4 and/or Chronic Moderate or Severe GVHD Chronic moderate or severe GVHD	16.7 percentage of participants Interval 6.6 to 30.7

SECONDARY outcome

Timeframe: At 2 years

Evaluated by estimating Kaplan-Meier survival curves. From these curves, the 95% confidence interval for 2 year rates will be computed.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Relapse Rate	15 percentage of participants Interval 6.0 to 27.8

SECONDARY outcome

Timeframe: 44 weeks

Hematopoietic engraftment will be defined as: * ANC ≥ 0.5x10e9/L for at least 3 days * Platelet engraftment \>20,000 with no transfusion x 7 days.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Engraftment Rates Median Neutrophil Engraftment	12 days Interval 9.0 to 14.0
Engraftment Rates Median Platelet Engraftment	17 days Interval 12.0 to 173.0

SECONDARY outcome

Timeframe: At 100 days

The estimates of incidence rates will be presented with corresponding 95% confidence intervals using the exact method.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Incidence of Treatment Related Mortality (TRM)	5 percentage of participants Interval 1.9 to 13.0

SECONDARY outcome

Timeframe: At 2 years

Evaluated by estimating Kaplan-Meier survival curves. From these curves, the 95% confidence interval for 2 year rates will be computed.

Outcome measures

Outcome measures
Measure	Treatment (Allogeneic PBSCT) n=40 Participants REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Relapse Related Mortality	12.5 percentage of participants Interval 3.7 to 42.0

SECONDARY outcome

Timeframe: 100 days post-transplant

Population: This outcome measure was prespecified in the protocol; however, no data were collected because the required assessments were not implemented during study conduct due to logistical and operational constraints. As these assessments were not performed at any time during the study, no data exist and none will become available in the future. Therefore, this outcome cannot be analyzed or reported.

To evaluate lymphoid reconstitution in patients treated on the Two Step approach

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Allogeneic PBSCT)

Serious events: 29 serious events

Other events: 40 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Allogeneic PBSCT) n=40 participants at risk REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Gastrointestinal disorders Abdominal Pain - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute kidney injury - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute kidney injury - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute kidney injury - Grade 4	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute Renal Failure - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute Renal Insufficiency - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders AKI - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Alanine aminotransferase increased - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Aspiration - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Atrial Fibrillation - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Back Pain - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations BK viremia/viuria (BK cystitis) - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Cystitis noninfective - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Death - Grade 5	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Decrease EF - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Dehydration - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Diarrhea - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Dysphagia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Dyspnea - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Ejection fraction decreased - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Endocrine- other (diabetes) - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Esophagitis - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Febrile neutropenia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fevers - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Hematuria - Grade 3	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV6 Reactivation - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HSV - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Hyperbilirubinemia/ Increased LFTs - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyperglycemia - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyperkalemia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypotension - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hypoxia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hypoxia - Grade 3	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hypoxia - Grade 4	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Increased bilirubin - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Increased bilirubin - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Infection - Other - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Infection - Other - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pneumonitis - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood and lymphatic disorders- other - Decreasing t cell chimerism worrisome for rejection - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood & Lymphatic system disorders - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood and lymphatic disorders- other (Lack of 100% t cell engraftment) - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood and lymphatic disorders- other (GVHD) - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood and lymphatic disorders- other (GVHD) - Grade 5	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood and lymphatic disorders- other (Infection, HHV-6) - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood and Lymphatic system disorders - mixed chimerisms - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Blood bilirubin increased - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Blood bilirubin increased - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood/Bone Marrow- other (BK cystitis) - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood/Bone Marrow- other (rash with history of GVHD) - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Blood/Bone Marrow- other (respiratory distress after platelet transfusion) - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Cardiac disorders- other (Vasovagal episode) - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations CMV Reactivation - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Constitutional symptoms- other (compound fractures in L1 and L2 with an extradural hematoma) - Grd 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Infections and infestations- other (Presumed sepsis) - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion Related Reaction - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Left ventricular systolic dysfunction - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Left ventricular systolic dysfunction - Grade 5	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders LV Failure - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mucositis - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Nausea - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Cardiac Disorders, Other - Pericardial Effusion - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Non-cardiac chest pain - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Opportunistic infection - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Opportunistic infection - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Orthostatic hypotension - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Pancytopenia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Pericardial effusion - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Pericardial tamponade - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Pneumonia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pneumonitis/Pulmonary infiltrates - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pulmonary edema - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Rash - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Rash maculopapular - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Renal Failure - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Renal Failure - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Renal/Genitourinary- other (increased creatinine) - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders- other - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Syncope - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations White Blood Cell Decreased	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant

Other adverse events

Other adverse events
Measure	Treatment (Allogeneic PBSCT) n=40 participants at risk REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
Musculoskeletal and connective tissue disorders Hernia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV-6 - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV6 activation - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV6 infection - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV-6 positive - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV6 Reactivation - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations HHV-6 Viremia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyperglycemia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hiccups - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hiccups - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Hip pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hot flashes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Hyperbilirubin - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Hyperbilirubin - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Hyperbilirubinemia - Grade 1	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Hyperbilirubinemia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyperkalemia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyperkalemia - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypernatremia - Grade 1	2.5% 1/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypernatremia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyperphosphatemia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Hyperpigmentation - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypertension - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypertension - Grade 2	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypertension - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypocalcemia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypocalcemia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypokalemia - Grade 1	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypokalemia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypokalemia - Grade 3	2.5% 1/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypokalemia - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Hyperhidrosis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypomagnesemia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyponatremia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hyponatremia - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypophosphatemia - Grade 3	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypotension - Grade 1	25.0% 10/40 • Number of events 11 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypotension - Grade 2	17.5% 7/40 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Hypokalemia/hyponatremic - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypotensive - GRade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Hypotensive - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Hypothermia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hypoxia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Hypoxia (infusion reaction) - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Infections and infestations-Other - Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion reaction - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Hypovolemic - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Hypoxia - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - Chills/ Nausea - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - Cough - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - Itchy/Hives - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - Mild Rigors - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - Mouth - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion related reaction - tachycardia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Insomnia - Grade 1	40.0% 16/40 • Number of events 16 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Irritable - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Irritable/ Agitated - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Irritable/ Anxiety - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Irritation - PICC site - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Itching - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Itchy skin - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Joint pain/Swelling - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Knee pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Left arm swelling - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Left extremity pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Left Shoulder/Neck Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Left upper extremity swelling - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Leg pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Leg pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Lethargic - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Lethargic - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Lethargic/fatigue - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Lethargy - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Lethargy/ Fatigue - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Lightheadedness - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Lower L Back Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Maculopapular rash - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion reaction - Headache - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Infusion reaction - Hives - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Memory Change - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Memory Change - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Maculopapular/erythematous rash - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Malaise - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolic acidosis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Myalgias - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Muscle Ache/Pain - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Muscle Aches - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Muscle/Joint pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Nasal Congestion - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Nasal Congestion - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Nausea - Grade 1	50.0% 20/40 • Number of events 23 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Nausea - Grade 2	20.0% 8/40 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Nausea - Grade 3	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Nausea and vomiting - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Neck Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Neuropathy - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Pain - PEG site - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Pain - R and L flank - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Pain - Right arm around PICC - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Pain - Shoulder/ Neck/ Back - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Pain - Soles and Palms - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Pain in buttocks region - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Pericardial effusion - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Pericatheter thrombus - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Reproductive system and breast disorders Perineum pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Peripheral edema - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Petechiae - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications PICC Site soreness-Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Platelet transfusion reaction - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pleural effusions - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pleural effusions - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Pneumonia - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Pneumonia - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Memory impairment/Confusion - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Mental confusion - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Rash - Grade 2	35.0% 14/40 • Number of events 17 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Rash - Grade 3	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Rectal Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Rectal Pain - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Renal and urinary disorders-Other-Dysuria - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Renal and urinary disorders-Other-Urinary Changes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Respiratory Distress - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Shortness of Breath - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Shortness of Breath - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Shoulder Pain - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Shoulder Pain - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Sinus congestion - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Sinus pain/congestion - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Sinus tachycardia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pneumonitis - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Polyuria - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Sweats - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Swollen Ankles - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Poor Oral Intake - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Presyncope - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Problems with Balance - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Prolonged QT interval - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Proteinuria - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Proteinuria - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Pruritis - Grade 1	20.0% 8/40 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Tachycardia - Grade 1	47.5% 19/40 • Number of events 22 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Tachycardia - Grade 2	15.0% 6/40 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Tachycardic - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Pruritis - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Psychiatric disorders-Other-Distress - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pulmonary edema - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Pulmonary edema - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Purulent drainage - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Rash - Grade 1	40.0% 16/40 • Number of events 18 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Tightness in Mouth - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Thrombolytic event - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Tingling - Lips - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Tooth Infection	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Total Body Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Transaminitis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Tremors - Grade 1	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Tachypnea - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Tachypnea - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Taste alterations - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Tremors - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Trouble Sleeping - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Typhlitis - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Reproductive system and breast disorders Testicular/Scrotal pain - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Thromboembolic event - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Upper respiratory infection - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary frequency - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary frequency - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary incontinence - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary incontinence - Grade 3	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary retention - Grade 2	12.5% 5/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary tract pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urinary urgency - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Urine incontinence - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Urine output decreased - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Reproductive system and breast disorders Vaginal bleeding/spotting - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Reproductive system and breast disorders Vaginal dryness - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Ventricular arrhythmia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Visual hallucinations - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Volume Overload - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Volume Overload - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Vomiting - Grade 1	52.5% 21/40 • Number of events 24 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Vomiting - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Weakness - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Weakness - LE - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Weight Increase - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Weight Loss - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Weight Loss - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Wheezing - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Urinary tract infection - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Urinary tract infection - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Wound - B/L Upper Buttocks - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations ALK Phosphate increase - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Alopecia - Grade 1	20.0% 8/40 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Altered mental status - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Anemic - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fatigue/Lethargy - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Feet pain - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fever - Grade 1	67.5% 27/40 • Number of events 38 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fever - Grade 2	15.0% 6/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fever - Grade 3	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fevers - Grade 1	67.5% 27/40 • Number of events 38 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fevers - Grade 2	17.5% 7/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fevers - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Flatulence - Grade 1	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Floaters - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Fluid Overload - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Fluid overload - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Fluid overload - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Flushing - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Foot pain - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Frustration - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Fungal rash - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Gastritis - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Gastroesophageal reflux disease - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fogginess - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Generalized discomfort - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Generalized itching - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Generalized joint/bone pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Generalized Pain/ Discomfort - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Ankle pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Anorexia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Anorexia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Anxiety - Grade 1	17.5% 7/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Anxiety - Grade 2	17.5% 7/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Anxious - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Anxious - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Arthralgias - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Aspiration - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations AST increased - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Atrial fibrillation - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Atrial fibrillation/ A Flutter - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Awakening at night urinate - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Awakening to urinate - Grade 1	17.5% 7/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders B/L Legs- cramping/discomfort - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Back pain - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Back pain - Grade 2	7.5% 3/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Back/Hip Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Back/Hip Pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Bacteremia - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Bacteremia - Grade 2	10.0% 4/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Bacteremia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Basilic vein thrombosis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Bilateral edema - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations BK Infection - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations BK viruria - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Back/Flank pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Bladder spasms - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Blisters/Wound - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Bloating - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Bloating/Gas - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chest pain - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chest pain - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chest/rib pain	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chills - Grade 1	25.0% 10/40 • Number of events 13 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chills - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chills/rigors - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Clostridium Difficile - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations CMV Activation - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations CMV reactivation - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations CMV reactivation - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations CMV reactivation - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Colitis - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Concentration impairment - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Confusion - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Confusion - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Constipation - Grade 1	37.5% 15/40 • Number of events 22 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Constipation - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Cough - Grade 1	35.0% 14/40 • Number of events 16 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Cough - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Decreased appetite - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Decreased appetite - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Decreased urine output - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Decreased Urine Output - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Dehydration - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Dehydration - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Dehydration - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Delirium - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Depression - Grade 1	27.5% 11/40 • Number of events 11 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Depression - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Diabetes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Diaphoresis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Diarrhea - Grade 1	42.5% 17/40 • Number of events 21 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Diarrhea - Grade 2	37.5% 15/40 • Number of events 20 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Diarrhea - Grade 3	45.0% 18/40 • Number of events 22 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Diarrhea/loose stools - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Difficulty sleeping - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Difficulty urinating - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Difficulty urination - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Difficulty with balance - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Discomfort at Picc site - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Disoriented - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Diverticulitis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Dizziness - Grade 1	22.5% 9/40 • Number of events 10 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders DOE - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Dry eyes - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Dry eyes - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Dry heaves - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Dry mouth - Grade 1	32.5% 13/40 • Number of events 13 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Dry mouth - grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Dry skin - Grade 1	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders DVT - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Dyspepsia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Dysphagia - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Dyspnea - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Dyspnea - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Dyspnea - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Dyspnea on exertion/SOB - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Dsypnea/SOB - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Dysuria - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Dysuria - Grade 2	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Erythema - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Erythema - right groin - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Erythema/rash - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Esophagitis - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Esophagitis - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Extremity weakness - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Facial swelling - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fatigue - Grade 1	37.5% 15/40 • Number of events 16 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Fatigue - Grade 2	15.0% 6/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Generalized rash - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Hematuria - Grade 3	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Hemolysis - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Hemorrhoid pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Hemorrhoids - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Hemorrhoids - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Achiness - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Acid Reflux - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Acid Reflux - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Acidosis- Grade 4	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute kidney injury - Grade 1	10.0% 4/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute kidney injury - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute kidney injury - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Acute renal insufficiency - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Acute thrombus - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Adenopathy - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Agitation - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Agitation - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders AKI - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders A Fib - grade 2	5.0% 2/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal Cramping - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal cramps - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal discomfort - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal distension - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal distenstion - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal distention - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal muscle pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal pain - Grade 1	22.5% 9/40 • Number of events 11 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal pain - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Abdominal tenderness - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Abnormal LFTs - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders blood and lymphatic system disorder, other - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Blood in stool - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Bloodshot/pink eyes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Blurred vision - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Blurry vision - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Bradycardia - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Bradycardia - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Bruises on abdomen - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations C. difficile - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Cardiac disorders-other-Murmur - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Cdiff - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations C-diff - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Cellulitis - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Change in vision - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Chapped lower lip - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Chest discomfort - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Ear and labyrinth disorders Left lateral ear suspected deep tissue injury (secondary to pressure) - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Edema - Grade 1	27.5% 11/40 • Number of events 11 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Edema - Grade 2	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Edema-arm - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Ejection fraction decreased - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Electrolyte imbalance - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Electrolyte imbalance - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Electrolyte imbalance - Grade 3	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Elevated LFTS/ hyperbilirubinemia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Elevated liver enzymes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Elevated transaminases/ ALK Phos - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Emesis - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Epigastric/chest pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Epigastric pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Epistaxis - Grade 1	7.5% 3/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Reproductive system and breast disorders Erectile dysfunction - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Generalized weakness/activity changes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Reproductive system and breast disorders Genital edema - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders GERD - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders GERD - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Groin rash - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Hallucination - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Hallucinations - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Psychiatric disorders Hallucinations - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Head pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Headache - Grade 1	37.5% 15/40 • Number of events 22 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Headache - Grade 2	12.5% 5/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Headaches - Grade 2	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Heartburn - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Heartburn - Grade 2	2.5% 1/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Hematuria - Grade 1	15.0% 6/40 • Number of events 6 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Hematuria - Grade 2	15.0% 6/40 • Number of events 7 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolic and nutrition disorders- other (low sodium, calcium, phosphate, and albumin) - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolic disorder- other (electrolyte imbalance) - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolism disorder - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolism disorder; other - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolism disorder; other - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Metabolism and nutrition disorders Metabolism disorder; other - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Migraine - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Mild Rash - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Mild Resting Tremor - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mouth Numbness - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mouth Sores - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mouth Sores/Dry Mouth - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mucositis - Grade 1	20.0% 8/40 • Number of events 8 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mucositis - Grade 2	42.5% 17/40 • Number of events 17 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Mucositis - Grade 3	22.5% 9/40 • Number of events 9 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Myalgias - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New pancreatic neoplasm - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders New Rash - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Night Sweats - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Nocturia - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Nocturia/Urinary frequency - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Non-cardiac chest pain - Grade 1	7.5% 3/40 • Number of events 4 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Numbness/Tingling - Legs - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Nystagmus - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Oliguria - Grade 2	2.5% 1/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Investigations Oliguria - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Orthostatic hypotension - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Vascular disorders Orthostatic hypotension - Grade 2	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Pain - Crawling Skin - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Pain - Bx Site - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Pain in extremities when becomes cold - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Pain in skin/arms - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Pain- right lower anterior chest wall - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Pain, other - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Painful swallowing/ Mucositis - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Renal and urinary disorders Painful/difficulty urination - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Pain - Jaw - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Palpitations - Grade 1	5.0% 2/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Palpitations - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Pancytopenia - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Blood and lymphatic system disorders Pancytopenia - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Papules - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Paresthesia - Grade 1	12.5% 5/40 • Number of events 5 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Paresthesia - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Perianal discomfort/Hemorrhoids - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Cardiac disorders Pericardial effusion - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Respiratory, thorasic, and mediastinal disorders-Other-Chronic Sinusitis - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Restless Legs - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Rhinitis - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Rhinitis - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Rhinorrhea - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Rhinovirus - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Rhonchi - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Rib Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Right Hip Discomfort - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Right plueral effusion - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Eye disorders Right subconjunctival hemorrhage - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Rigors - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
General disorders Rigors - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders RUE Pain - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Sensitive Fingers - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Infections and infestations Sepsis - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders-Other-Bump on head - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders-Other-Hot flashes - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders-Other-Toe abrasion - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin discoloration - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin hyperpigmentation - Grade 1	2.5% 1/40 • Number of events 2 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin Rash - Papules - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin Tear - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Skin ulceration - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Small intestinal Obstruction - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Nervous system disorders Somnolence - Grade 3	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Sore throat - Grade 1	7.5% 3/40 • Number of events 3 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Respiratory, thoracic and mediastinal disorders Sore throat - Grade 2	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Musculoskeletal and connective tissue disorders Soreness - Buttocks - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Injury, poisoning and procedural complications Soreness at PICC site - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Gastrointestinal disorders Stomach Pain - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
Skin and subcutaneous tissue disorders Sweats - Grade 1	2.5% 1/40 • Number of events 1 • All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant

Additional Information

Dolores Grosso

Tevogen Bio

Phone: 848-256-5751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place