Trial Outcomes & Findings for Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation (NCT NCT01596257)

Last Updated: 2022-12-29

Results Overview

Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of \>/= 0.5 x 10\^9/L

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

Up to 100 weeks

Results posted on

2022-12-29

Participant Flow

The study goal was to explore fractionated HPC infusion in humans in a setting of commonly used conditioning regimens. The design included stratification of randomization by transplant type. Additional stratification would have increased the accrual target for statistical power, prolonging enrollment. In our publication reporting results of this trial (Tamari et al. JTCT 2021) we provide data stratified by treatment arm and transplant type for secondary endpoints for easier interpretation.

Participant milestones

Participant milestones
Measure	Bulk Stem Cell Transplantation/SCT Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Fractionated Stem Cell Transplantation/SCT Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Overall Study STARTED	61	55
Overall Study COMPLETED	38	36
Overall Study NOT COMPLETED	23	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Bulk Stem Cell Transplantation/SCT Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Fractionated Stem Cell Transplantation/SCT Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Overall Study Inadequate Collection	23	19

Baseline Characteristics

Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bulk Stem Cell Transplantation/SCT n=61 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Fractionated Stem Cell Transplantation/SCT n=55 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Total n=116 Participants Total of all reporting groups
Age, Continuous	59 years n=93 Participants	59 years n=4 Participants	59 years n=27 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	19 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	36 Participants n=4 Participants	67 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=93 Participants	55 Participants n=4 Participants	111 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	51 Participants n=93 Participants	48 Participants n=4 Participants	99 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment United States	61 Participants n=93 Participants	55 Participants n=4 Participants	116 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 100 weeks

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=36 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=38 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Median Time to Engraftment of Neutrophils	11 days Interval 9.0 to 22.0	11 days Interval 9.0 to 22.0

SECONDARY outcome

Timeframe: 2 years

Participants will be assessed for toxicities with the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=55 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=61 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Number of Participants Assessed for Toxicities Participants who experienced toxicities	36 Participants	38 Participants
Number of Participants Assessed for Toxicities Participants who did not experience toxicities	19 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 365 days

The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365. Determine days to platelet engraftment by platelet count.

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=36 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=38 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Median Time to Platelet Engraftment	18 days Interval 4.0 to 47.0	18 days Interval 9.0 to 112.0

SECONDARY outcome

Timeframe: 24 months

Percentage of participants alive at 24 months

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=36 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=38 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Overall Survival	62 % of participants alive	60 % of participants alive

SECONDARY outcome

Timeframe: 30 days

Determine the difference of CD4+ lymphocyte recovery between the two arms on day 30

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=36 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=38 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Hematopoietic Function on Day 30	6 cells/mm^3 Interval 0.0 to 678.0	0 cells/mm^3 Interval 0.0 to 1473.0

SECONDARY outcome

Timeframe: 180 days

Determine the difference of CD4+ lymphocyte recovery between the two arms on day 180

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=36 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=38 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Hematopoietic Function on Day 180	111 cells/mm^3 Interval 0.0 to 4180.0	179 cells/mm^3 Interval 0.0 to 799.0

SECONDARY outcome

Timeframe: 360 days

Determine the difference of CD4+ lymphocyte recovery between the two arms on day 360

Outcome measures

Outcome measures
Measure	Fractionated Stem Cell Transplantation/SCT n=36 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Bulk SCT n=38 Participants Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Hematopoietic Function on Day 360	280 cells/mm^3 Interval 27.0 to 928.0	294 cells/mm^3 Interval 0.0 to 1076.0

Adverse Events

Bulk Stem Cell Transplantation/SCT

Serious events: 21 serious events

Other events: 38 other events

Deaths: 26 deaths

Fractionated Stem Cell Transplantation/SCT

Serious events: 12 serious events

Other events: 36 other events

Deaths: 23 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Sergio Giralt, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bulk Stem Cell Transplantation/SCT n=61 participants at risk Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS	Fractionated Stem Cell Transplantation/SCT n=55 participants at risk Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
Blood and lymphatic system disorders Febrile Neutropenia	32.8% 20/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	41.8% 23/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Infections and infestations Infections and infestations - Other, specify	37.7% 23/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	21.8% 12/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Mucositis oral	49.2% 30/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	30.9% 17/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Vascular disorders Hypertension	4.9% 3/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	12.7% 7/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Vascular disorders Hypotension	18.0% 11/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	12.7% 7/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Colitis	11.5% 7/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue disorders Other, spec	0.00% 0/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Abdominal pain	0.00% 0/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	10.9% 6/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Investigations Alanine aminotransferase increased	19.7% 12/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	20.0% 11/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Investigations Alkaline phosphatase increased	4.9% 3/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Immune system disorders Allergic reaction	4.9% 3/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Metabolism and nutrition disorders Anorexia	29.5% 18/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	23.6% 13/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Psychiatric disorders Anxiety	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Investigations Aspartate aminotransferase increased	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	10.9% 6/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Investigations Blood bilirubin increased	9.8% 6/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Infections and infestations Catheter related infection	16.4% 10/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	14.5% 8/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Hepatobiliary disorders Cholecystitis	4.9% 3/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Psychiatric disorders Confusion	4.9% 3/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Metabolism and nutrition disorders Dehydration	8.2% 5/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Diarrhea	31.1% 19/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	34.5% 19/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Respiratory, thoracic and mediastinal disorders Dyspnea	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	9.1% 5/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Respiratory, thoracic and mediastinal disorders Epistaxis	9.8% 6/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	12.7% 7/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Esophagitis	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
General disorders Fatigue	14.8% 9/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	12.7% 7/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Nervous system disorders Headache	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Metabolism and nutrition disorders Hyperglycemia	39.3% 24/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	23.6% 13/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Respiratory, thoracic and mediastinal disorders Hypoxia	18.0% 11/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	12.7% 7/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Injury, poisoning and procedural complications Infusion related reaction	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Infections and infestations Lung infection	31.1% 19/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	12.7% 7/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Nausea	29.5% 18/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	27.3% 15/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
General disorders Pain	0.00% 0/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	9.1% 5/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Skin and subcutaneous tissue disorders Rash maculo-papular	23.0% 14/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	20.0% 11/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Cardiac disorders Sinus tachycardia	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Nervous system disorders Syncope	6.6% 4/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Upper gastrointestinal hemorrhage	4.9% 3/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	0.00% 0/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
Gastrointestinal disorders Vomiting	13.1% 8/61 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification	5.5% 3/55 • 2 years Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification