Trial Outcomes & Findings for Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies (NCT NCT00544466)

Last Updated: 2025-06-03

Results Overview

Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

100 days post treatment

Results posted on

2025-06-03

Participant Flow

Among the 75 patients, who consented to the study, 13 of them became ineligible after screening. So only 62 patients received the study treatment.

Participant milestones

Participant milestones
Measure	Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) PREPARATIVE REGIMEN\: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
Overall Study STARTED	62
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) n=75 Participants PREPARATIVE REGIMEN\: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days post treatment

Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) n=62 Participants PREPARATIVE REGIMEN\: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.	793 events

SECONDARY outcome

Timeframe: Up to 180 days post-transplant

Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 180 days after transplant and Kaplan-Meier survival analysis was used to generate the Overall Survival estimate at 180 days.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) n=62 Participants PREPARATIVE REGIMEN\: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
Overall Survival on Day 180 Days Post-transplant	81 Percent Probability Interval 68.0 to 89.0

Adverse Events

Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)

Serious events: 13 serious events

Other events: 61 other events

Deaths: 43 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) n=62 participants at risk PREPARATIVE REGIMEN\: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
Blood and lymphatic system disorders Hemorrhage, CNS	1.6% 1/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage, pulmonary/upper respiratory	1.6% 1/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Thrombotic microangiopathy	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Cardiac General - Other (Specify, __)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Cardiopulmonary arrest, cause unknown (non-fatal)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Hypotension	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Left ventricular diastolic dysfunction	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Supraventricular and nodal arrhythmia	8.1% 5/62 • Number of events 7 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Ventricular arrhythmia	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Ear and labyrinth disorders Auditory/Ear - Other (Specify, __)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Fistula, GI	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Weight gain	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)	11.3% 7/62 • Number of events 7 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection with unknown ANC	1.6% 1/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection, Bacterial	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection, Fungal	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection, Viral	3.2% 2/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Bilirubin (hyperbilirubinemia)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Calcium, serum-low (hypocalcemia)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Creatinine	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Glucose, serum-high (hyperglycemia)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Phosphate, serum-low (hypophosphatemia)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Potassium, serum-low (hypokalemia)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Proteinuria	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Triglyceride, serum-high (hypertriglyceridemia)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Apnea	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Confusion	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Encephalopathy	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Neurology - Other (Specify, __)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Neuropathy: motor	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Somnolence/depressed level of consciousness	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Cystitis	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Renal failure	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.3% 7/62 • Number of events 7 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	3.2% 2/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Prolonged intubation after pulmonary resection (>24 hrs after surgery)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Rash/desquamation	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Surgical and medical procedures Intra-operative injury	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant) n=62 participants at risk PREPARATIVE REGIMEN\: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
Blood and lymphatic system disorders Coagulation - Other (Specify, __)	4.8% 3/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Edema:head and neck	22.6% 14/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Edema:limb	46.8% 29/62 • Number of events 30 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Edema:trunk/genital	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Edema:viscera	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hematoma	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemoglobin	30.6% 19/62 • Number of events 23 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage, CNS	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage, GI	17.7% 11/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage, GU	25.8% 16/62 • Number of events 17 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage, pulmonary/upper respiratory	25.8% 16/62 • Number of events 17 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage/Bleeding - Other (Specify, __)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Hemorrhage/bleeding associated with surgery, intra-operative or postoperative	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders INR (International Normalized Ratio of prothrombin time)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Leukocytes (total WBC)	30.6% 19/62 • Number of events 24 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Lymphatics - Other (Specify, __)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Lymphopenia	22.6% 14/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	32.3% 20/62 • Number of events 20 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	21.0% 13/62 • Number of events 13 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	11.3% 7/62 • Number of events 7 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Platelets	32.3% 20/62 • Number of events 26 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Portal vein flow	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Thrombosis/thrombus/embolism	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Blood and lymphatic system disorders Thrombotic microangiopathy	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Cardiac Arrhythmia - Other (Specify, __)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Cardiac General - Other (Specify, __)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Cardiac ischemia/infarction	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Cardiac troponin I (cTnI)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Conduction abnormality/atrioventricular heart block	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Hypertension	54.8% 34/62 • Number of events 35 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Hypotension	29.0% 18/62 • Number of events 20 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Left ventricular diastolic dysfunction	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Palpitations	9.7% 6/62 • Number of events 6 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Pericardial effusion (non-malignant)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Pericarditis	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Prolonged QTc interval	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Supraventricular and nodal arrhythmia	29.0% 18/62 • Number of events 22 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Valvular heart disease	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Cardiac disorders Ventricular arrhythmia	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Ear and labyrinth disorders Hearing: patients without baseline audiogram and not enrolled in a monitoring program	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Endocrine disorders Neuroendocrine: gonadotropin secretion abnormality	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Endocrine disorders Pancreatic endocrine: glucose intolerance	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Endocrine disorders Parathyroid function, low (hypoparathyroidism)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Endocrine disorders Thyroid function, low (hypothyroidism)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Eye disorders Nystagmus	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Eye disorders Ocular/Visual - Other (Specify, __)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Eye disorders Vision-blurred vision	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Anorexia	69.4% 43/62 • Number of events 45 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Ascites (non-malignant)	12.9% 8/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Colitis	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Constipation	21.0% 13/62 • Number of events 13 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Diarrhea	90.3% 56/62 • Number of events 57 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Distension/bloating, abdominal	21.0% 13/62 • Number of events 13 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	16.1% 10/62 • Number of events 10 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	21.0% 13/62 • Number of events 13 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Enteritis (inflammation of the small bowel)	8.1% 5/62 • Number of events 5 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Esophagitis	16.1% 10/62 • Number of events 10 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Flatulence	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	21.0% 13/62 • Number of events 13 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Gastrointestinal - Other (Specify, __)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Heartburn/dyspepsia	29.0% 18/62 • Number of events 18 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Hemorrhoids	9.7% 6/62 • Number of events 6 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	8.1% 5/62 • Number of events 5 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Incontinence, anal	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)	67.7% 42/62 • Number of events 45 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)	54.8% 34/62 • Number of events 48 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Nausea	96.8% 60/62 • Number of events 61 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Necrosis, GI	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Obstruction, GI	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Perforation, GI	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Taste alteration (dysgeusia)	11.3% 7/62 • Number of events 7 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Typhlitis (cecal inflammation)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Ulcer, GI	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Gastrointestinal disorders Vomiting	74.2% 46/62 • Number of events 47 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Fatigue (asthenia, lethargy, malaise)	72.6% 45/62 • Number of events 46 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Hypothermia	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Insomnia	27.4% 17/62 • Number of events 17 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Pain	93.5% 58/62 • Number of events 216 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Pain - Other (Specify, __)	9.7% 6/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Rigors/chills	24.2% 15/62 • Number of events 15 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Sweating (diaphoresis)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Weight gain	38.7% 24/62 • Number of events 24 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
General disorders Weight loss	19.4% 12/62 • Number of events 12 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Hepatobiliary disorders Cholecystitis	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Hepatobiliary disorders Hepatobiliary/Pancreas - Other (Specify, __)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Immune system disorders Allergy/Immunology - Other (Specify, __)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	14.5% 9/62 • Number of events 10 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C)	17.7% 11/62 • Number of events 11 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)	38.7% 24/62 • Number of events 42 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection - Other (Specify, __)	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	12.9% 8/62 • Number of events 16 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection with unknown ANC	6.5% 4/62 • Number of events 6 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection, Bacterial	40.3% 25/62 • Number of events 41 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection, Fungal	12.9% 8/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Infection, Viral	21.0% 13/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Infections and infestations Viral hepatitis	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	79.0% 49/62 • Number of events 52 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	80.6% 50/62 • Number of events 52 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Acidosis (metabolic or respiratory)	9.7% 6/62 • Number of events 6 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Albumin, serum-low (hypoalbuminemia)	93.5% 58/62 • Number of events 62 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Alkaline phosphatase	59.7% 37/62 • Number of events 39 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Alkalosis (metabolic or respiratory)	14.5% 9/62 • Number of events 9 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Amylase	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Bicarbonate, serum-low	12.9% 8/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Bilirubin (hyperbilirubinemia)	21.0% 13/62 • Number of events 13 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations CPK (creatine phosphokinase)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Calcium, serum-high (hypercalcemia)	30.6% 19/62 • Number of events 19 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Calcium, serum-low (hypocalcemia)	90.3% 56/62 • Number of events 60 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Cholesterol, serum-high (hypercholesteremia)	37.1% 23/62 • Number of events 23 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Creatinine	46.8% 29/62 • Number of events 29 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Glucose, serum-high (hyperglycemia)	85.5% 53/62 • Number of events 54 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Glucose, serum-low (hypoglycemia)	14.5% 9/62 • Number of events 9 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Magnesium, serum-high (hypermagnesemia)	32.3% 20/62 • Number of events 20 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Magnesium, serum-low (hypomagnesemia)	95.2% 59/62 • Number of events 59 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Metabolic/Laboratory - Other (Specify, __)	27.4% 17/62 • Number of events 17 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Phosphate, serum-low (hypophosphatemia)	74.2% 46/62 • Number of events 47 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Potassium, serum-high (hyperkalemia)	30.6% 19/62 • Number of events 19 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Potassium, serum-low (hypokalemia)	87.1% 54/62 • Number of events 57 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Proteinuria	16.1% 10/62 • Number of events 11 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Sodium, serum-high (hypernatremia)	12.9% 8/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Sodium, serum-low (hyponatremia)	91.9% 57/62 • Number of events 57 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Syndromes - Other (Specify, __)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Investigations Triglyceride, serum-high (hypertriglyceridemia)	82.3% 51/62 • Number of events 53 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Metabolism and nutrition disorders Obesity	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Musculoskeletal and connective tissue disorders Joint-effusion	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	14.5% 9/62 • Number of events 9 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Specify, __)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Musculoskeletal and connective tissue disorders Osteoporosis	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Ataxia (incoordination)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Cognitive disturbance	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Confusion	32.3% 20/62 • Number of events 21 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Dizziness	16.1% 10/62 • Number of events 11 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Encephalopathy	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Leukoencephalopathy (radiographic findings)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Memory impairment	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Mental status	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Mood alteration	59.7% 37/62 • Number of events 52 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Neurology - Other (Specify, __)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Neuropathy: cranial	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Neuropathy: motor	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Neuropathy: sensory	21.0% 13/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Psychosis (hallucinations/delusions)	12.9% 8/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Seizure	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Somnolence/depressed level of consciousness	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Syncope (fainting)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Nervous system disorders Tremor	27.4% 17/62 • Number of events 17 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Bladder spasms	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Cystitis	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Incontinence, urinary	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Renal failure	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Renal/Genitourinary - Other (Specify, __)	8.1% 5/62 • Number of events 5 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Urinary frequency/urgency	17.7% 11/62 • Number of events 11 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Renal and urinary disorders Urine color change	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Reproductive system and breast disorders Sexual/Reproductive Function - Other (Specify, __)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Reproductive system and breast disorders Vaginal discharge (non-infectious)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Atelectasis	11.3% 7/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Cough	24.2% 15/62 • Number of events 15 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	22.6% 14/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	12.9% 8/62 • Number of events 8 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	17.7% 11/62 • Number of events 12 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	8.1% 5/62 • Number of events 5 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	24.2% 15/62 • Number of events 16 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	22.6% 14/62 • Number of events 14 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __)	8.1% 5/62 • Number of events 7 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify, __)	4.8% 3/62 • Number of events 3 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Dry skin	9.7% 6/62 • Number of events 6 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Flushing	6.5% 4/62 • Number of events 4 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	24.2% 15/62 • Number of events 15 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Hyperpigmentation	29.0% 18/62 • Number of events 18 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Hypopigmentation	3.2% 2/62 • Number of events 2 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Induration/fibrosis (skin and subcutaneous tissue)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Photosensitivity	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Pruritus/itching	62.9% 39/62 • Number of events 40 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Rash/desquamation	69.4% 43/62 • Number of events 45 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	8.1% 5/62 • Number of events 5 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation	8.1% 5/62 • Number of events 5 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Ulceration	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.
Skin and subcutaneous tissue disorders Wound complication, non-infectious	1.6% 1/62 • Number of events 1 • Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 12 years.

Additional Information

Dr. Jeffrey Wong, MD

City of Hope Medical Center

Phone: 6263598111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place