Trial Outcomes & Findings for Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant (NCT NCT03057054)

NCT ID: NCT03057054

Last Updated: 2025-10-06

Results Overview

The proportion of eligible patients having stage 1-4 GI aGvHD occur from Day 0 through Day 120 will be compared between the two arms.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 173 participants
• Primary outcome timeframe: Up to 120 days post stem cell infusion
• Results posted on: 2025-10-06

Participant Flow

Enrollment through day 120 post-stem cell infusion

Participant milestones

Measure	Arm I (Lactobacillus Plantarum, alloHCT) Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Arm II (Placebo, alloHCT) Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Overall Study STARTED	85	88
Overall Study Prior to Initial Stem Cell Infusion	83	86
Overall Study Initial Stem Cell Infusion	78	81
Overall Study COMPLETED	74	80
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Measure	Arm I (Lactobacillus Plantarum, alloHCT) Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Arm II (Placebo, alloHCT) Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Overall Study Death	4	4
Overall Study Withdrawal by Subject	6	3
Overall Study Ineligible	1	1

Baseline Characteristics

Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant

Baseline characteristics by cohort

Measure	Arm I (Lactobacillus Plantarum, alloHCT) n=85 Participants Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Arm II (Placebo, alloHCT) n=88 Participants Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Total n=173 Participants Total of all reporting groups
Age, Categorical <=18 years	74 Participants n=5 Participants	76 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.7 years STANDARD_DEVIATION 6.0 • n=5 Participants	12.1 years STANDARD_DEVIATION 5.6 • n=7 Participants	11.4 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	53 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	60 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	83 participants n=7 Participants	161 participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 120 days post stem cell infusion

Population: 2 patients were excluded because they were not eligible (1 patient from Group 1 and 1 patient from Group 2). 2 patients were excluded because they did not initiate treatment (1 patient from Group 1 and 1 patient from Group 2). 10 patients were excluded because they never received a stem cell infusion within 6 months of enrollment (5 patients from Group 1 and 5 patients from Group 2).

The proportion of eligible patients having stage 1-4 GI aGvHD occur from Day 0 through Day 120 will be compared between the two arms.

Outcome measures

Measure	Arm I (Lactobacillus Plantarum, alloHCT) n=78 Participants Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Arm II (Placebo, alloHCT) n=81 Participants Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Proportion of Participants With Stage 1-4 Gastrointestinal (GI) Acute Graft Versus Host Disease (aGVHD)	0.15 Proportion of patients Interval 0.08 to 0.25	0.15 Proportion of patients Interval 0.08 to 0.24

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

A similar analysis approach will be used as described for the primary outcome measure but using the dichotomous cumulative incidence of grade II-IV acute graft versus host disease as the endpoint measure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

The risk of mucosal barrier blood stream infections will be compared between two groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

Proportion of C. diff-associated diarrhea during the study period will be compared between arms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

The change in citrulline levels from baseline to each of the time points (days 7, 14, 28, 56, and 120 post-infusion) will be summarized and described by arm.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

LBP introduction on the intestinal flora via LBP administration will be compared with bacterial genes and pathways, and bacterial metabolites via correlation analyses. Also, dDescriptive analysis will be used to examine the association between the graft versus host disease outcomes (GI aGvHD and overall GvHD) and bacterial genes, pathways, and metabolites.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

The association between Lactobacillus plantarum administration and bacterial genes and pathways, and bacterial metabolites will be evaluated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

The effects of Lactobacillus plantarum on pro-inflammatory (LBP) cytokines in allogeneic hematopoietic cell transplantation recipients will be examined by comparing levels across arms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

Total hospital days over the study period is calculated as the duration between the date of admission for conditional therapy and the date of discharge (or the study end date). Hospital days will be compared between arms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 120 days post stem cell infusion

Patients who have at least one incidence (positive) of lactobacillus plantarum during any reporting period is considered evaluable for this aim. The proportion of patients experiencing lactobacillus plantarum bacteremia during the study period will be compared between arms.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Lactobacillus Plantarum, alloHCT)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 4 deaths

Arm II (Placebo, alloHCT)

Serious events: 8 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Measure	Arm I (Lactobacillus Plantarum, alloHCT) n=84 participants at risk Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Arm II (Placebo, alloHCT) n=87 participants at risk Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Renal and urinary disorders Acute kidney injury	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Bacteremia	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Vascular disorders Capillary leak syndrome	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Cytomegalovirus infection reactivation	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Cardiac disorders Cardiac arrest	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
General disorders Death NOS	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Gastric ulcer	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Renal and urinary disorders Hematuria	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Blood and lymphatic system disorders Hemolytic uremic syndrome	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Hepatobiliary disorders Hepatic hemorrhage	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Infections and infestations - Other, specify	2.4% 2/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	4.6% 4/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Nausea	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Hepatobiliary disorders Sinusoidal obstruction syndrome	2.4% 2/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Typhlitis	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Viremia	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.

Other adverse events

Measure	Arm I (Lactobacillus Plantarum, alloHCT) n=84 participants at risk Patients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.	Arm II (Placebo, alloHCT) n=87 participants at risk Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Gastrointestinal disorders Abdominal pain	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Blood and lymphatic system disorders Anemia	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Metabolism and nutrition disorders Anorexia	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Immune system disorders Autoimmune disorder	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Diarrhea	2.4% 2/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Enterocolitis infectious	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Metabolism and nutrition disorders Hyperglycemia	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Vascular disorders Hypertension	2.4% 2/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Infections and infestations - Other, specify	2.4% 2/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Mucositis oral	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	2.3% 2/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Gastrointestinal disorders Nausea	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Sepsis	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Hepatobiliary disorders Sinusoidal obstruction syndrome	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	0.00% 0/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.
Infections and infestations Cytomegalovirus	0.00% 0/84 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.	1.1% 1/87 • Collected Adverse Events within the 100 day observation period Adverse event reporting is collected routinely using case report forms. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. All-Cause Mortality events were monitored/assessed in all randomized participants. Serious and Other Adverse Events were monitored/assessed only in the eligible participants.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 16264470064

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

• Principal investigator is a sponsor employee Must obtain prior Sponsor approval
• Publication restrictions are in place

Restriction type: OTHER