Trial Outcomes & Findings for Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant (NCT NCT01244906)

Last Updated: 2015-05-01

Results Overview

To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

1 year

Results posted on

2015-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Overall Study STARTED	26
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Overall Study Death	2
Overall Study Progression of disease post treatment	6

Baseline Characteristics

Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Age, Continuous	61 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	21 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
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Incidence of GVHD	12 participants

SECONDARY outcome

Timeframe: Approximately Day 30

To estimate the incidence of neutrophil and platelet engraftment

Outcome measures

Outcome measures
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment	26 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Number of Participants With Non-Relapse Mortality	1 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Number of Patients With Disease Free Survival at 2 Years	17 participants

SECONDARY outcome

Timeframe: 1 year

Characterize rate of achievement of full donor chimerism

Outcome measures

Outcome measures
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Number of Patients to Achieve Full Donor Chimerism	26 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 Participants All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Number of Patients With Overall Survival at 2 Years.	19 participants

Adverse Events

Reduced Intensity Allogeneic Stem Cell Transplantation

Serious events: 10 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 participants at risk All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Respiratory, thoracic and mediastinal disorders pneumonia	11.5% 3/26 • Number of events 3
Gastrointestinal disorders Acute Cholecystitis	3.8% 1/26 • Number of events 1
Gastrointestinal disorders GI bleeding	7.7% 2/26 • Number of events 2
Respiratory, thoracic and mediastinal disorders pulmonary embolism	3.8% 1/26 • Number of events 1
Vascular disorders cellulitis	3.8% 1/26 • Number of events 1
Hepatobiliary disorders VOD	3.8% 1/26 • Number of events 1
Investigations Severe Hyperglycemia	3.8% 1/26 • Number of events 1

Other adverse events

Other adverse events
Measure	Reduced Intensity Allogeneic Stem Cell Transplantation n=26 participants at risk All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Gastrointestinal disorders Nausea	92.3% 24/26
General disorders "cold sweats"	7.7% 2/26
General disorders "cold" feeling	7.7% 2/26
Gastrointestinal disorders abdominal bloating	30.8% 8/26
Gastrointestinal disorders abdominal cramps	30.8% 8/26
Gastrointestinal disorders abdominal discomfort/pain	53.8% 14/26
Gastrointestinal disorders abdominal distention	50.0% 13/26
Gastrointestinal disorders abdominal tenderness	19.2% 5/26
Psychiatric disorders agitation	11.5% 3/26
Hepatobiliary disorders increased alkaline phosphatase	65.4% 17/26
General disorders alopecia	11.5% 3/26
Hepatobiliary disorders increased alanine aminotransferase	69.2% 18/26
Blood and lymphatic system disorders neutropenia	100.0% 26/26
Blood and lymphatic system disorders anemia	100.0% 26/26
Gastrointestinal disorders anorexia/decreased oral intake	42.3% 11/26
Psychiatric disorders anxiety	80.8% 21/26
Musculoskeletal and connective tissue disorders arm pain	11.5% 3/26
Gastrointestinal disorders ascites	19.2% 5/26
Hepatobiliary disorders increased aspartate aminotransferase	53.8% 14/26
Musculoskeletal and connective tissue disorders ataxia	42.3% 11/26
Musculoskeletal and connective tissue disorders back pain	46.2% 12/26
Infections and infestations bacteremia	23.1% 6/26
Musculoskeletal and connective tissue disorders bilateral knee pain	7.7% 2/26
Infections and infestations BKV cystitis	46.2% 12/26
Renal and urinary disorders bladder cramping	7.7% 2/26
Renal and urinary disorders bladder pain	26.9% 7/26
Renal and urinary disorders bladder spasms	23.1% 6/26
Gastrointestinal disorders bloody stool	7.7% 2/26
Eye disorders blurry vision	15.4% 4/26
Renal and urinary disorders benign prostatic hyperplasia	7.7% 2/26
Cardiac disorders bradycardia	23.1% 6/26
Skin and subcutaneous tissue disorders bruising	38.5% 10/26
Gastrointestinal disorders clostridium difficile colitis	15.4% 4/26
Infections and infestations cellulitis	11.5% 3/26
Cardiac disorders chest pressure	7.7% 2/26
General disorders chills/rigors	53.8% 14/26
Infections and infestations CMV reactivation	7.7% 2/26
Psychiatric disorders confusion	7.7% 2/26
Gastrointestinal disorders constipation	50.0% 13/26
Respiratory, thoracic and mediastinal disorders dry cough	65.4% 17/26
Respiratory, thoracic and mediastinal disorders coarse breath sounds	11.5% 3/26
Renal and urinary disorders increased creatinine	34.6% 9/26
General disorders central venous catheter pain	57.7% 15/26
General disorders central venous catheter site drainage	19.2% 5/26
General disorders central venous catheter site erythema	30.8% 8/26
General disorders deconditioning	38.5% 10/26
Metabolism and nutrition disorders decreased appetite	69.2% 18/26
Gastrointestinal disorders decreased bowel movement frequency	7.7% 2/26
Respiratory, thoracic and mediastinal disorders decreased breath sounds	38.5% 10/26
Metabolism and nutrition disorders decreased fluid intake	19.2% 5/26
Psychiatric disorders depression	50.0% 13/26
Skin and subcutaneous tissue disorders diaphoretic skin	7.7% 2/26
Gastrointestinal disorders diarrhea	88.5% 23/26
Gastrointestinal disorders dysphagia	26.9% 7/26
Nervous system disorders dizziness	34.6% 9/26
Nervous system disorders drowsiness	46.2% 12/26
Eye disorders dry eyes	23.1% 6/26
Gastrointestinal disorders dry lips	7.7% 2/26
Gastrointestinal disorders dry mouth	34.6% 9/26
Skin and subcutaneous tissue disorders dry skin	38.5% 10/26
Vascular disorders deep venous thrombosis	7.7% 2/26
Renal and urinary disorders dysuria	61.5% 16/26
Ear and labyrinth disorders ear fullness/pressure	7.7% 2/26
Metabolism and nutrition disorders electrolyte wasting syndrome	7.7% 2/26
Blood and lymphatic system disorders enlarged lymph nodes	7.7% 2/26
Gastrointestinal disorders epigastric pain	7.7% 2/26
Respiratory, thoracic and mediastinal disorders epistaxis	30.8% 8/26
Gastrointestinal disorders esophagitis	7.7% 2/26
Skin and subcutaneous tissue disorders excoriation	11.5% 3/26
General disorders facial edema	7.7% 2/26
General disorders fatigue	84.6% 22/26
General disorders fever	76.9% 20/26
Psychiatric disorders flat affect	26.9% 7/26
Vascular disorders fluid overload	34.6% 9/26
Vascular disorders facial flushing	15.4% 4/26
Skin and subcutaneous tissue disorders folliculitis	15.4% 4/26
Gastrointestinal disorders gas/flatulence	11.5% 3/26
Musculoskeletal and connective tissue disorders generalized achiness	26.9% 7/26
Skin and subcutaneous tissue disorders generalized skin erythema	15.4% 4/26
Gastrointestinal disorders GERD	73.1% 19/26
Immune system disorders skin GVHD	42.3% 11/26
Immune system disorders gut GVHD	7.7% 2/26
Psychiatric disorders hallucinations	7.7% 2/26
Nervous system disorders headache	61.5% 16/26
Vascular disorders hematoma	7.7% 2/26
Renal and urinary disorders hematuria	46.2% 12/26
Respiratory, thoracic and mediastinal disorders hemoptysis	11.5% 3/26
Gastrointestinal disorders perirectal bleeding/hemorrhage	26.9% 7/26
Gastrointestinal disorders hemorrhodial edema	7.7% 2/26
Gastrointestinal disorders hemorrhodial pain	15.4% 4/26
Gastrointestinal disorders hemorrhoids	26.9% 7/26
Musculoskeletal and connective tissue disorders hernia	7.7% 2/26
Skin and subcutaneous tissue disorders hives	7.7% 2/26
Gastrointestinal disorders hyperactive bowel sounds	23.1% 6/26
Hepatobiliary disorders hyperbilirubinemia	42.3% 11/26
Metabolism and nutrition disorders hypercalcemia	15.4% 4/26
Metabolism and nutrition disorders hyperglycemia	100.0% 26/26
Metabolism and nutrition disorders hyperkalemia	11.5% 3/26
Metabolism and nutrition disorders hypernatremia	53.8% 14/26
Skin and subcutaneous tissue disorders hyperpigmentation	26.9% 7/26
Cardiac disorders hypertension	61.5% 16/26
Metabolism and nutrition disorders hypoalbuminemia	76.9% 20/26
Metabolism and nutrition disorders hypocalcemia	76.9% 20/26
Metabolism and nutrition disorders hypoglycemia	7.7% 2/26
Metabolism and nutrition disorders hypokalemia	69.2% 18/26
Metabolism and nutrition disorders hypomagnesemia	61.5% 16/26
Metabolism and nutrition disorders hyponatremia	34.6% 9/26
Cardiac disorders hypotension	50.0% 13/26
Respiratory, thoracic and mediastinal disorders hypoxemic respiratory failure	7.7% 2/26
Gastrointestinal disorders stool incontinence	15.4% 4/26
Respiratory, thoracic and mediastinal disorders increased respiration rate	7.7% 2/26
Psychiatric disorders insomnia	50.0% 13/26
Musculoskeletal and connective tissue disorders joint aches	11.5% 3/26
General disorders lower-extremity edema	65.4% 17/26
Musculoskeletal and connective tissue disorders leg pain	7.7% 2/26
Nervous system disorders lethargy	38.5% 10/26
Musculoskeletal and connective tissue disorders limited mobility	19.2% 5/26
General disorders lip edema	7.7% 2/26
Nervous system disorders loss of coordination/balance	19.2% 5/26
Respiratory, thoracic and mediastinal disorders lung crackles	38.5% 10/26
Blood and lymphatic system disorders lymphadenopathy	7.7% 2/26
Gastrointestinal disorders malnutrition	7.7% 2/26
Metabolism and nutrition disorders metabolic acidosis	7.7% 2/26
Gastrointestinal disorders mouth sores	34.6% 9/26
Gastrointestinal disorders mouth tenderness	38.5% 10/26
Infections and infestations MRSE bacteremia	11.5% 3/26
Gastrointestinal disorders mucositis	57.7% 15/26
Musculoskeletal and connective tissue disorders muscle weakness	7.7% 2/26
Respiratory, thoracic and mediastinal disorders nasal congestion	38.5% 10/26
Respiratory, thoracic and mediastinal disorders nasal drainage	26.9% 7/26
Nervous system disorders neuropathy	26.9% 7/26
Blood and lymphatic system disorders febrile neutropenia	57.7% 15/26
Renal and urinary disorders nocturia	7.7% 2/26
Skin and subcutaneous tissue disorders oral erythema	11.5% 3/26
Vascular disorders oral thrush	7.7% 2/26
Cardiac disorders orthostatic hypotension	7.7% 2/26
Gastrointestinal disorders pain during defication	7.7% 2/26
Respiratory, thoracic and mediastinal disorders pain with breathing	11.5% 3/26
Musculoskeletal and connective tissue disorders hip pain	7.7% 2/26
Musculoskeletal and connective tissue disorders foot pain	7.7% 2/26
Musculoskeletal and connective tissue disorders lower-extremity pain	7.7% 2/26
Musculoskeletal and connective tissue disorders neck pain	7.7% 2/26
Musculoskeletal and connective tissue disorders pelvic pain	11.5% 3/26
Musculoskeletal and connective tissue disorders shoulder pain	15.4% 4/26
Gastrointestinal disorders throat pain	50.0% 13/26
Skin and subcutaneous tissue disorders pale skin	11.5% 3/26
Respiratory, thoracic and mediastinal disorders parainfluenza	11.5% 3/26
Skin and subcutaneous tissue disorders penile lesions	11.5% 3/26
Hepatobiliary disorders perihepatic ascites	7.7% 2/26
Eye disorders periorbital edema	7.7% 2/26
Eye disorders periorbital redness	7.7% 2/26
General disorders peripheral edema	11.5% 3/26
Gastrointestinal disorders perirectal irritation	15.4% 4/26
Gastrointestinal disorders perirectal pain	15.4% 4/26
Blood and lymphatic system disorders petechiae	7.7% 2/26
Respiratory, thoracic and mediastinal disorders pleural effusion	23.1% 6/26
Cardiac disorders pleuritic chest pain	11.5% 3/26
Respiratory, thoracic and mediastinal disorders pneumonia	19.2% 5/26
Respiratory, thoracic and mediastinal disorders post-nasal drip	15.4% 4/26
Skin and subcutaneous tissue disorders pruritus	65.4% 17/26
Respiratory, thoracic and mediastinal disorders pulmonary infiltrates	19.2% 5/26
Respiratory, thoracic and mediastinal disorders pulmonary nodules	7.7% 2/26
Respiratory, thoracic and mediastinal disorders pulmonary opacites	15.4% 4/26
Skin and subcutaneous tissue disorders rash	76.9% 20/26
Respiratory, thoracic and mediastinal disorders respiratory distress	11.5% 3/26
Respiratory, thoracic and mediastinal disorders respiratory insufficiency	19.2% 5/26
Nervous system disorders restless leg syndrome	7.7% 2/26
Respiratory, thoracic and mediastinal disorders rhinorrhea	23.1% 6/26
Respiratory, thoracic and mediastinal disorders rhinovirus/URI	26.9% 7/26
Respiratory, thoracic and mediastinal disorders rhonchi	19.2% 5/26
Musculoskeletal and connective tissue disorders ribcage tenderness	7.7% 2/26
General disorders seasonal allergies	34.6% 9/26
Nervous system disorders sedation	15.4% 4/26
Respiratory, thoracic and mediastinal disorders sinus congestion	26.9% 7/26
Respiratory, thoracic and mediastinal disorders sinus drainage	53.8% 14/26
Respiratory, thoracic and mediastinal disorders sinus pressure	11.5% 3/26
Respiratory, thoracic and mediastinal disorders chronic sinusitis	15.4% 4/26
Skin and subcutaneous tissue disorders skin abrasion	11.5% 3/26
Skin and subcutaneous tissue disorders skin color changes	11.5% 3/26
Skin and subcutaneous tissue disorders skin erythema	11.5% 3/26
Skin and subcutaneous tissue disorders skin lesions	15.4% 4/26
Skin and subcutaneous tissue disorders skin sensitivity	7.7% 2/26
Skin and subcutaneous tissue disorders skin tear	7.7% 2/26
Skin and subcutaneous tissue disorders skin tenderness	7.7% 2/26
Respiratory, thoracic and mediastinal disorders sneezing	7.7% 2/26
Respiratory, thoracic and mediastinal disorders shortness of breath	57.7% 15/26
General disorders splenomegaly	7.7% 2/26
Infections and infestations staphylococcus epidermis bacteremia	7.7% 2/26
Metabolism and nutrition disorders steroid-induced diabetes	23.1% 6/26
Gastrointestinal disorders stomatitis	11.5% 3/26
Musculoskeletal and connective tissue disorders suprapubic tenderness	7.7% 2/26
Nervous system disorders sweats	23.1% 6/26
Cardiac disorders tachycardia	65.4% 17/26
General disorders taste changes	26.9% 7/26
Blood and lymphatic system disorders thrombocytopenia	100.0% 26/26
Nervous system disorders tremors	19.2% 5/26
Nervous system disorders unsteady gait	7.7% 2/26
Renal and urinary disorders urinary frequency	57.7% 15/26
Renal and urinary disorders urinary hesitancy	11.5% 3/26
Renal and urinary disorders urinary incontinence	15.4% 4/26
Renal and urinary disorders urinary retention	19.2% 5/26
Renal and urinary disorders urinary urgency	23.1% 6/26
Renal and urinary disorders urinary tract infection	7.7% 2/26
Nervous system disorders visual changes	15.4% 4/26
Hepatobiliary disorders veno-occlusive disease	7.7% 2/26
General disorders volume depletion	11.5% 3/26
Gastrointestinal disorders vomiting	80.8% 21/26
Infections and infestations VRE positive	23.1% 6/26
Blood and lymphatic system disorders leukopenia	100.0% 26/26
General disorders generalized weakness	57.7% 15/26
Investigations weight gain	19.2% 5/26
Investigations weight loss	46.2% 12/26
Respiratory, thoracic and mediastinal disorders wheezing	30.8% 8/26

Additional Information

Scott R. Solomon, MD

Blood and Marrow Transplant Group of Georgia

Phone: 404-255-1930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place