Trial Outcomes & Findings for Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia (NCT NCT01885689)

Last Updated: 2025-11-14

Results Overview

Progression-free survival (PFS) is defined as time from start of protocol treatment to disease relapse/progression, death or last contact, whichever occurs first. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

From start of protocol treatment to death due to any cause, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years.

Results posted on

2025-11-14

Participant Flow

72 patients consented to the study. 52 of them became eligible and received the study treatment.

Participant milestones

Participant milestones
Measure	Treatment (Clofarabine, Melphalan, Transplant) CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Clofarabine, Melphalan, Transplant) n=52 Participants CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
Age, Continuous	62 years n=10 Participants
Sex: Female, Male Female	27 Participants n=10 Participants
Sex: Female, Male Male	25 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants
Region of Enrollment United States	52 participants n=10 Participants

PRIMARY outcome

Timeframe: From start of protocol treatment to death due to any cause, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years.

Outcome measures

Outcome measures
Measure	Treatment (Clofarabine, Melphalan, Transplant) n=52 Participants CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
Progression-free Survival at 2 Years	54 percent probability Interval 39.0 to 66.0

SECONDARY outcome

Timeframe: From start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years.

Overall survival (OS) is defined as time from start of protocol treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula.

Outcome measures

Outcome measures
Measure	Treatment (Clofarabine, Melphalan, Transplant) n=52 Participants CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
Overall Survival at 2 Years	67 percent probability Interval 53.0 to 78.0

Adverse Events

Treatment (Clofarabine, Melphalan, Transplant)

Serious events: 16 serious events

Other events: 52 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Clofarabine, Melphalan, Transplant) n=52 participants at risk CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.9% 1/52 • 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 6 years.
Cardiac disorders Atrial fibrillation	3.8% 2/52 • 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 6 years.
Cardiac disorders Cardiac disorders - Other, specify	1.9% 1/52 • 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 6 years.
Cardiac disorders Myocarditis	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Diarrhea	1.9% 1/52 • 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 6 years.
General disorders Fever	3.8% 2/52 • 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 6 years.
General disorders Multi-organ failure	1.9% 1/52 • 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 6 years.
Infections and infestations Catheter related infection	1.9% 1/52 • 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 6 years.
Infections and infestations Encephalitis infection	1.9% 1/52 • 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 6 years.
Infections and infestations Infections and infestations - Other, specify	3.8% 2/52 • 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 6 years.
Infections and infestations Lung infection	3.8% 2/52 • 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 6 years.
Infections and infestations Sepsis	5.8% 3/52 • 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 6 years.
Injury, poisoning and procedural complications Fracture	1.9% 1/52 • 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 6 years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	1.9% 1/52 • 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 6 years.
Investigations Urine output decreased	1.9% 1/52 • 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 6 years.
Metabolism and nutrition disorders Anorexia	1.9% 1/52 • 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 6 years.
Metabolism and nutrition disorders Hypoglycemia	1.9% 1/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	1.9% 1/52 • 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 6 years.
Nervous system disorders Spasticity	1.9% 1/52 • 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 6 years.
Renal and urinary disorders Acute kidney injury	3.8% 2/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.7% 4/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	7.7% 4/52 • 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 6 years.
Vascular disorders Hypotension	1.9% 1/52 • 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 6 years.
Vascular disorders Thromboembolic event	1.9% 1/52 • 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 6 years.

Other adverse events

Other adverse events
Measure	Treatment (Clofarabine, Melphalan, Transplant) n=52 participants at risk CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4. TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure. clofarabine: Given IV melphalan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant tacrolimus: Given IV or PO sirolimus: Given PO Pharmacological Study: Correlative studies
Blood and lymphatic system disorders Anemia	98.1% 51/52 • Number of events 118 • 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 6 years.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	9.6% 5/52 • 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 6 years.
Blood and lymphatic system disorders Febrile neutropenia	59.6% 31/52 • Number of events 34 • 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 6 years.
Blood and lymphatic system disorders Spleen disorder	1.9% 1/52 • 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 6 years.
Cardiac disorders Acute coronary syndrome	1.9% 1/52 • 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 6 years.
Cardiac disorders Atrial fibrillation	7.7% 4/52 • 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 6 years.
Cardiac disorders Atrial flutter	3.8% 2/52 • 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 6 years.
Cardiac disorders Cardiac disorders - Other, specify	23.1% 12/52 • 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 6 years.
Cardiac disorders Chest pain - cardiac	11.5% 6/52 • 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 6 years.
Cardiac disorders Heart failure	5.8% 3/52 • 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 6 years.
Cardiac disorders Palpitations	5.8% 3/52 • 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 6 years.
Cardiac disorders Pericardial effusion	3.8% 2/52 • 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 6 years.
Cardiac disorders Sinus bradycardia	5.8% 3/52 • 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 6 years.
Cardiac disorders Sinus tachycardia	34.6% 18/52 • 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 6 years.
Cardiac disorders Supraventricular tachycardia	1.9% 1/52 • 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 6 years.
Cardiac disorders Ventricular arrhythmia	1.9% 1/52 • 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 6 years.
Congenital, familial and genetic disorders Congenital, familial and genetic disorders - Other, specify	1.9% 1/52 • 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 6 years.
Ear and labyrinth disorders Hearing impaired	1.9% 1/52 • 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 6 years.
Ear and labyrinth disorders Vertigo	1.9% 1/52 • 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 6 years.
Endocrine disorders Endocrine disorders - Other, specify	3.8% 2/52 • 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 6 years.
Endocrine disorders Hyperthyroidism	1.9% 1/52 • 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 6 years.
Endocrine disorders Hypothyroidism	3.8% 2/52 • 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 6 years.
Eye disorders Dry eye	1.9% 1/52 • 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 6 years.
Eye disorders Eye disorders - Other, specify	13.5% 7/52 • 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 6 years.
Eye disorders Eye pain	5.8% 3/52 • 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 6 years.
Eye disorders Floaters	1.9% 1/52 • 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 6 years.
Eye disorders Vitreous hemorrhage	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Abdominal distension	26.9% 14/52 • 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 6 years.
Gastrointestinal disorders Abdominal pain	69.2% 36/52 • Number of events 55 • 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 6 years.
Gastrointestinal disorders Anal pain	3.8% 2/52 • 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 6 years.
Gastrointestinal disorders Ascites	3.8% 2/52 • 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 6 years.
Gastrointestinal disorders Bloating	26.9% 14/52 • 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 6 years.
Gastrointestinal disorders Colitis	3.8% 2/52 • 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 6 years.
Gastrointestinal disorders Colonic hemorrhage	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Colonic ulcer	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Constipation	42.3% 22/52 • Number of events 27 • 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 6 years.
Gastrointestinal disorders Diarrhea	98.1% 51/52 • Number of events 87 • 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 6 years.
Gastrointestinal disorders Dry mouth	13.5% 7/52 • 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 6 years.
Gastrointestinal disorders Dyspepsia	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Dysphagia	9.6% 5/52 • 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 6 years.
Gastrointestinal disorders Enterocolitis	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Esophageal pain	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Esophageal ulcer	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Esophagitis	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Fecal incontinence	7.7% 4/52 • 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 6 years.
Gastrointestinal disorders Flatulence	3.8% 2/52 • 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 6 years.
Gastrointestinal disorders Gastritis	3.8% 2/52 • 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 6 years.
Gastrointestinal disorders Gastroesophageal reflux disease	11.5% 6/52 • 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 6 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	44.2% 23/52 • Number of events 44 • 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 6 years.
Gastrointestinal disorders Hemorrhoids	11.5% 6/52 • 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 6 years.
Gastrointestinal disorders Ileus	3.8% 2/52 • 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 6 years.
Gastrointestinal disorders Mucositis oral	55.8% 29/52 • Number of events 37 • 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 6 years.
Gastrointestinal disorders Nausea	94.2% 49/52 • Number of events 94 • 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 6 years.
Gastrointestinal disorders Oral pain	21.2% 11/52 • 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 6 years.
Gastrointestinal disorders Pancreatitis	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Rectal pain	23.1% 12/52 • 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 6 years.
Gastrointestinal disorders Small intestinal mucositis	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Typhlitis	1.9% 1/52 • 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 6 years.
Gastrointestinal disorders Vomiting	73.1% 38/52 • 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 6 years.
General disorders Chills	23.1% 12/52 • 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 6 years.
General disorders Edema face	9.6% 5/52 • 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 6 years.
General disorders Edema limbs	57.7% 30/52 • 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 6 years.
General disorders Facial pain	1.9% 1/52 • 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 6 years.
General disorders Fatigue	90.4% 47/52 • Number of events 92 • 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 6 years.
General disorders Fever	9.6% 5/52 • 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 6 years.
General disorders Flu like symptoms	1.9% 1/52 • 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 6 years.
General disorders Gait disturbance	3.8% 2/52 • 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 6 years.
General disorders General disorders and administration site conditions - Other, specify	55.8% 29/52 • 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 6 years.
General disorders Injection site reaction	1.9% 1/52 • 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 6 years.
General disorders Irritability	1.9% 1/52 • 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 6 years.
General disorders Localized edema	3.8% 2/52 • 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 6 years.
General disorders Malaise	3.8% 2/52 • 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 6 years.
General disorders Neck edema	5.8% 3/52 • 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 6 years.
General disorders Non-cardiac chest pain	19.2% 10/52 • 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 6 years.
General disorders Pain	28.8% 15/52 • 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 6 years.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	5.8% 3/52 • 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 6 years.
Hepatobiliary disorders Portal hypertension	1.9% 1/52 • 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 6 years.
Immune system disorders Allergic reaction	5.8% 3/52 • 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 6 years.
Immune system disorders Immune system disorders - Other, specify	42.3% 22/52 • Number of events 31 • 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 6 years.
Infections and infestations Appendicitis perforated	1.9% 1/52 • 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 6 years.
Infections and infestations Catheter related infection	11.5% 6/52 • 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 6 years.
Infections and infestations Enterocolitis infectious	9.6% 5/52 • 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 6 years.
Infections and infestations Infections and infestations - Other, specify	26.9% 14/52 • Number of events 27 • 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 6 years.
Infections and infestations Lung infection	1.9% 1/52 • 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 6 years.
Infections and infestations Papulopustular rash	1.9% 1/52 • 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 6 years.
Infections and infestations Sepsis	1.9% 1/52 • 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 6 years.
Infections and infestations Sinusitis	7.7% 4/52 • 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 6 years.
Infections and infestations Urinary tract infection	7.7% 4/52 • 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 6 years.
Infections and infestations Vaginal infection	1.9% 1/52 • 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 6 years.
Injury, poisoning and procedural complications Bruising	7.7% 4/52 • 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 6 years.
Injury, poisoning and procedural complications Fall	1.9% 1/52 • 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 6 years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	7.7% 4/52 • 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 6 years.
Investigations Alanine aminotransferase increased	84.6% 44/52 • Number of events 78 • 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 6 years.
Investigations Alkaline phosphatase increased	28.8% 15/52 • 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 6 years.
Investigations Aspartate aminotransferase increased	84.6% 44/52 • Number of events 68 • 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 6 years.
Investigations Blood bilirubin increased	23.1% 12/52 • 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 6 years.
Investigations CPK increased	1.9% 1/52 • 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 6 years.
Investigations Cardiac troponin I increased	9.6% 5/52 • 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 6 years.
Investigations Cholesterol high	7.7% 4/52 • 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 6 years.
Investigations Creatinine increased	23.1% 12/52 • 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 6 years.
Investigations Electrocardiogram QT corrected interval prolonged	1.9% 1/52 • 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 6 years.
Investigations Haptoglobin decreased	1.9% 1/52 • 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 6 years.
Investigations INR increased	5.8% 3/52 • 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 6 years.
Investigations Investigations - Other, specify	36.5% 19/52 • 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 6 years.
Investigations Lymphocyte count decreased	100.0% 52/52 • Number of events 104 • 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 6 years.
Investigations Neutrophil count decreased	98.1% 51/52 • Number of events 100 • 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 6 years.
Investigations Platelet count decreased	100.0% 52/52 • Number of events 110 • 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 6 years.
Investigations Serum amylase increased	1.9% 1/52 • 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 6 years.
Investigations Urine output decreased	1.9% 1/52 • 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 6 years.
Investigations Weight gain	40.4% 21/52 • Number of events 28 • 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 6 years.
Investigations Weight loss	26.9% 14/52 • 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 6 years.
Investigations White blood cell decreased	100.0% 52/52 • Number of events 107 • 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 6 years.
Metabolism and nutrition disorders Acidosis	5.8% 3/52 • 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 6 years.
Metabolism and nutrition disorders Alkalosis	5.8% 3/52 • 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 6 years.
Metabolism and nutrition disorders Anorexia	86.5% 45/52 • Number of events 80 • 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 6 years.
Metabolism and nutrition disorders Dehydration	1.9% 1/52 • 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 6 years.
Metabolism and nutrition disorders Hypercalcemia	3.8% 2/52 • 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 6 years.
Metabolism and nutrition disorders Hyperglycemia	75.0% 39/52 • Number of events 78 • 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 6 years.
Metabolism and nutrition disorders Hyperkalemia	9.6% 5/52 • 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 6 years.
Metabolism and nutrition disorders Hypermagnesemia	19.2% 10/52 • 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 6 years.
Metabolism and nutrition disorders Hypernatremia	13.5% 7/52 • 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 6 years.
Metabolism and nutrition disorders Hypertriglyceridemia	78.8% 41/52 • Number of events 56 • 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 6 years.
Metabolism and nutrition disorders Hyperuricemia	7.7% 4/52 • 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 6 years.
Metabolism and nutrition disorders Hypoalbuminemia	96.2% 50/52 • Number of events 89 • 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 6 years.
Metabolism and nutrition disorders Hypocalcemia	69.2% 36/52 • Number of events 58 • 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 6 years.
Metabolism and nutrition disorders Hypoglycemia	3.8% 2/52 • 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 6 years.
Metabolism and nutrition disorders Hypokalemia	90.4% 47/52 • Number of events 87 • 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 6 years.
Metabolism and nutrition disorders Hypomagnesemia	92.3% 48/52 • Number of events 73 • 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 6 years.
Metabolism and nutrition disorders Hyponatremia	90.4% 47/52 • Number of events 79 • 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 6 years.
Metabolism and nutrition disorders Hypophosphatemia	78.8% 41/52 • 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 6 years.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	36.5% 19/52 • Number of events 86 • 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 6 years.
Metabolism and nutrition disorders Obesity	15.4% 8/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Arthritis	1.9% 1/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Back pain	44.2% 23/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Bone pain	9.6% 5/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	15.4% 8/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	1.9% 1/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	23.1% 12/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 4/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Neck pain	17.3% 9/52 • 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 6 years.
Musculoskeletal and connective tissue disorders Pain in extremity	44.2% 23/52 • Number of events 34 • 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 6 years.
Musculoskeletal and connective tissue disorders Scoliosis	1.9% 1/52 • 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 6 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	5.8% 3/52 • 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 6 years.
Nervous system disorders Concentration impairment	1.9% 1/52 • 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 6 years.
Nervous system disorders Dizziness	11.5% 6/52 • 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 6 years.
Nervous system disorders Dysgeusia	15.4% 8/52 • 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 6 years.
Nervous system disorders Dysphasia	1.9% 1/52 • 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 6 years.
Nervous system disorders Encephalopathy	1.9% 1/52 • 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 6 years.
Nervous system disorders Headache	76.9% 40/52 • Number of events 65 • 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 6 years.
Nervous system disorders Lethargy	11.5% 6/52 • 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 6 years.
Nervous system disorders Memory impairment	5.8% 3/52 • 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 6 years.
Nervous system disorders Movements involuntary	1.9% 1/52 • 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 6 years.
Nervous system disorders Nervous system disorders - Other, specify	7.7% 4/52 • 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 6 years.
Nervous system disorders Paresthesia	1.9% 1/52 • 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 6 years.
Nervous system disorders Peripheral sensory neuropathy	13.5% 7/52 • 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 6 years.
Nervous system disorders Presyncope	1.9% 1/52 • 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 6 years.
Nervous system disorders Sinus pain	1.9% 1/52 • 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 6 years.
Nervous system disorders Somnolence	3.8% 2/52 • 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 6 years.
Nervous system disorders Tremor	15.4% 8/52 • 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 6 years.
Psychiatric disorders Agitation	9.6% 5/52 • 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 6 years.
Psychiatric disorders Anxiety	42.3% 22/52 • Number of events 32 • 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 6 years.
Psychiatric disorders Confusion	23.1% 12/52 • 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 6 years.
Psychiatric disorders Delirium	1.9% 1/52 • 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 6 years.
Psychiatric disorders Depression	15.4% 8/52 • 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 6 years.
Psychiatric disorders Hallucinations	9.6% 5/52 • 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 6 years.
Psychiatric disorders Insomnia	67.3% 35/52 • Number of events 49 • 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 6 years.
Psychiatric disorders Psychiatric disorders - Other, specify	19.2% 10/52 • 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 6 years.
Psychiatric disorders Psychosis	1.9% 1/52 • 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 6 years.
Psychiatric disorders Restlessness	23.1% 12/52 • 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 6 years.
Renal and urinary disorders Acute kidney injury	13.5% 7/52 • 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 6 years.
Renal and urinary disorders Hematuria	19.2% 10/52 • 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 6 years.
Renal and urinary disorders Proteinuria	32.7% 17/52 • 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 6 years.
Renal and urinary disorders Renal and urinary disorders - Other, specify	26.9% 14/52 • 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 6 years.
Renal and urinary disorders Urinary frequency	7.7% 4/52 • 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 6 years.
Renal and urinary disorders Urinary incontinence	7.7% 4/52 • 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 6 years.
Renal and urinary disorders Urinary retention	3.8% 2/52 • 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 6 years.
Renal and urinary disorders Urinary tract pain	3.8% 2/52 • 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 6 years.
Renal and urinary disorders Urinary urgency	1.9% 1/52 • 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 6 years.
Reproductive system and breast disorders Pelvic pain	1.9% 1/52 • 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 6 years.
Reproductive system and breast disorders Penile pain	1.9% 1/52 • 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 6 years.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	3.8% 2/52 • 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 6 years.
Reproductive system and breast disorders Scrotal pain	1.9% 1/52 • 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 6 years.
Reproductive system and breast disorders Vaginal hemorrhage	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Apnea	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Atelectasis	19.2% 10/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 13/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	23.1% 12/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.5% 6/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Hiccups	3.8% 2/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.8% 2/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.5% 6/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	19.2% 10/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	21.2% 11/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.8% 3/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Productive cough	3.8% 2/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	7.7% 4/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	36.5% 19/52 • Number of events 32 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Sleep apnea	1.9% 1/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Sore throat	30.8% 16/52 • 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 6 years.
Respiratory, thoracic and mediastinal disorders Wheezing	11.5% 6/52 • 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 6 years.
Skin and subcutaneous tissue disorders Dry skin	23.1% 12/52 • 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 6 years.
Skin and subcutaneous tissue disorders Erythema multiforme	3.8% 2/52 • 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 6 years.
Skin and subcutaneous tissue disorders Pain of skin	1.9% 1/52 • 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 6 years.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	11.5% 6/52 • 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 6 years.
Skin and subcutaneous tissue disorders Periorbital edema	1.9% 1/52 • 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 6 years.
Skin and subcutaneous tissue disorders Pruritus	61.5% 32/52 • Number of events 43 • 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 6 years.
Skin and subcutaneous tissue disorders Rash acneiform	1.9% 1/52 • 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 6 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	65.4% 34/52 • 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 6 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	42.3% 22/52 • Number of events 33 • 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 6 years.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.8% 2/52 • 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 6 years.
Skin and subcutaneous tissue disorders Skin ulceration	3.8% 2/52 • 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 6 years.
Skin and subcutaneous tissue disorders Urticaria	1.9% 1/52 • 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 6 years.
Vascular disorders Flushing	9.6% 5/52 • 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 6 years.
Vascular disorders Hematoma	3.8% 2/52 • 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 6 years.
Vascular disorders Hypertension	76.9% 40/52 • Number of events 71 • 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 6 years.
Vascular disorders Hypotension	25.0% 13/52 • 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 6 years.
Vascular disorders Thromboembolic event	1.9% 1/52 • 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 6 years.
Vascular disorders Vascular disorders - Other, specify	3.8% 2/52 • 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 6 years.

Additional Information

Dr. Monzi M.Al Malki, MD

City of Hope

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place