Trial Outcomes & Findings for An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD) (NCT NCT03339297)

NCT ID: NCT03339297

Last Updated: 2021-08-18

Results Overview

Cumulative Incidence Percentage of Grade B to D aGvHD was defined using the International Bone Marrow Transplant Registry (IBMTR) Severity Index. Grade B is defined as Skin stage = 2 or Liver stage = 1 to 2 or GI stage = 1 to 2. Grade C is defined as Skin stage = 3 or Liver stage = 3 or GI stage = 3. Grade D is defined as a Skin stage = 4 or Liver stage = 4 or GI stage = 4.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 152 participants
• Primary outcome timeframe: HSCT Day (Day +0 post-HSCT) through Day +100 post-HSCT
• Results posted on: 2021-08-18

Participant Flow

Informed Consent and/or assent was obtained from participants, parents/legal guardians or representatives.

Participant milestones

Measure	Defibrotide Prophylaxis Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Overall Study STARTED	79	73
Overall Study COMPLETED	56	59
Overall Study NOT COMPLETED	23	14

Reasons for withdrawal

Measure	Defibrotide Prophylaxis Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Overall Study Relapse of Hematologic Disease	1	0
Overall Study Death	10	7
Overall Study Hepatic Candidosis	1	0
Overall Study Adverse Event, Serious Fatal	0	2
Overall Study Consent Withdrawn by Participant	3	3
Overall Study Disease Relapse	2	0
Overall Study Physician Decision	1	1
Overall Study Relapse of Disease New Transplant Performed	1	0
Overall Study Problems with Donor and Diagnosis of Early Relapse	1	0
Overall Study Early Termination, Did Not Proceed to Transplant	1	0
Overall Study Adverse Event, Non-fatal	1	0
Overall Study Patient Relapsed and Did Not Proceed to Transplant	0	1
Overall Study Patient Was Not Eligible	1	0

Baseline Characteristics

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

Baseline characteristics by cohort

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.	Total n=152 Participants Total of all reporting groups
Age, Continuous	50.54 years STANDARD_DEVIATION 16.952 • n=5 Participants	51.09 years STANDARD_DEVIATION 16.621 • n=7 Participants	50.80 years STANDARD_DEVIATION 16.741 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants	63 Participants n=7 Participants	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	63 Participants n=7 Participants	129 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: HSCT Day (Day +0 post-HSCT) through Day +100 post-HSCT

Population: Cumulative Incidence Rate of Grade B to D Acute Graft Versus Host Disease (aGvHD) was assessed using the Intent-to-Treat Analysis Set.

Cumulative Incidence Percentage of Grade B to D aGvHD was defined using the International Bone Marrow Transplant Registry (IBMTR) Severity Index. Grade B is defined as Skin stage = 2 or Liver stage = 1 to 2 or GI stage = 1 to 2. Grade C is defined as Skin stage = 3 or Liver stage = 3 or GI stage = 3. Grade D is defined as a Skin stage = 4 or Liver stage = 4 or GI stage = 4.

Outcome measures

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Cumulative Incidence Percentage of Grade B to D Acute Graft Versus Host Disease (aGvHD) by Day +100 Post-Hematopoietic Stem Cell Transplant (HSCT)	38.4 cumulative incidence percentage	47.1 cumulative incidence percentage

SECONDARY outcome

Timeframe: HSCT Day (Day +0 post-HSCT) through Day +180 post-HSCT

Population: Cumulative Incidence Rate of Grade B to D Acute Graft Versus Host Disease (aGvHD) was assessed using the Intent-to-Treat Analysis Set.

Cumulative Incidence Percentage of Grade B to D aGvHD was defined using the IBMTR Severity Index. Grade B is defined as Skin stage = 2 or Liver stage = 1 to 2 or GI stage = 1 to 2. Grade C is defined as Skin stage = 3 or Liver stage = 3 or GI stage = 3. Grade D is defined as a Skin stage = 4 or Liver stage = 4 or GI stage = 4.

Outcome measures

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Cumulative Incidence Percentage of Grade B to D aGvHD by Day +180 Post-HSCT	50.6 cumulative incidence percentage	51.6 cumulative incidence percentage

SECONDARY outcome

Timeframe: HSCT Day (Day +0 post-HSCT) through Days +100 and +180 post-HSCT

Population: Kaplan-Meier Estimate of Grade B to D aGvHD-free Survival was assessed using the Intent-to-Treat Analysis Set.

Grade B to D aGvHD was defined using the IBMTR Severity Index. Grade B is defined as Skin stage = 2 or Liver stage = 1 to 2 or GI stage = 1 to 2. Grade C is defined as Skin stage = 3 or Liver stage = 3 or GI stage = 3. Grade D is defined as a Skin stage = 4 or Liver stage = 4 or GI stage = 4.

Outcome measures

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Kaplan-Meier Estimate of Grade B to D aGvHD-free Survival by Days +100 and +180 Post-HSCT Day +100 post-HSCT	60.3 percentage of participants	51.4 percentage of participants
Kaplan-Meier Estimate of Grade B to D aGvHD-free Survival by Days +100 and +180 Post-HSCT Day +180 post-HSCT	45.1 percentage of participants	42.6 percentage of participants

SECONDARY outcome

Timeframe: HSCT Day (Day +0 post-HSCT) through Days +100 and +180 post-HSCT

Population: Cumulative Incidence Rate of Grade C to D Acute Graft Versus Host Disease (aGvHD) was assessed using the Intent-to-Treat Analysis Set.

Cumulative Incidence Percentage of Grade C to D aGvHD was defined using the IBMTR Severity Index. Grade C is defined as Skin stage = 3 or Liver stage = 3 or GI stage = 3. Grade D is defined as a Skin stage = 4 or Liver stage = 4 or GI stage = 4.

Outcome measures

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Cumulative Incidence Percentage of Grade C to D aGvHD by Days +100 and +180 Post-HSCT Day +180 post-HSCT	22.7 cumulative incidence percentage	25.9 cumulative incidence percentage
Cumulative Incidence Percentage of Grade C to D aGvHD by Days +100 and +180 Post-HSCT Day +100 post-HSCT	16.5 cumulative incidence percentage	21.5 cumulative incidence percentage

SECONDARY outcome

Timeframe: HSCT Day (Day +0 post-HSCT) through Days +100 and +180 post-HSCT

Population: Cumulative Incidence Rate of Disease Relapse was assessed using the Intent-to-Treat Analysis Set.

Disease relapse was defined by either morphological evidence of acute leukemia or Myelodysplastic syndrome (MDS) consistent with pre-transplant features, documented or not by biopsy. The event was defined as an increase in size of prior sites of disease or evidence of new sites of disease, documented or not by biopsy. Disease relapse was diagnosed when there was morphological or clinical evidence of the following: reappearance of leukemia blast cells in the peripheral blood, or >5% blasts in the bone marrow (BM), not attributable to another cause (eg, BM regeneration), or the appearance of previous or new dysplastic changes (MDS specific) within the BM, with or without falling donor chimerism, or the development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid, or institution of therapy to treat relapsed disease, including donor lymphocyte infusion.

Outcome measures

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Cumulative Incidence Percentage of Disease Relapse by Days +100 and +180 Post-HSCT Day +100 post-HSCT	11.0 cumulative incidence percentage	4.3 cumulative incidence percentage
Cumulative Incidence Percentage of Disease Relapse by Days +100 and +180 Post-HSCT Day +180 post-HSCT	16.8 cumulative incidence percentage	5.8 cumulative incidence percentage

SECONDARY outcome

Timeframe: HSCT Day (Day +0 post-HSCT) through Day +180 post-HSCT

Population: Cumulative Incidence Rate of Systemic Steroids for the Treatment of aGvHD was assessed using the Intent-to-Treat Analysis Set.

For each treatment arm, the cumulative incidence rate of systemic steroid use for the treatment of aGvHD by Day +180 post-HSCT will be estimated using the cumulative incidence competing risk estimator. The calculation of the cumulative incidence rates and the stratified Gray's test was carried out using the LIFETEST procedure in SAS version 9.4. If the participant experienced a competing risk event, then the initiation date was used to calculate the time-to-event variable.

Outcome measures

Measure	Defibrotide Prophylaxis n=79 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=73 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Cumulative Incidence Percentage of Systemic Steroids for the Treatment of aGvHD +180 Days Post-HSCT	38.2 cumulative incidence percentage	28.6 cumulative incidence percentage

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) total score is the sum of the FACT physical wellbeing score, the FACT social/family wellbeing score, the FACT emotional wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. The FACT physical wellbeing subscale scores range from a minimum of 0 to a maximum of 28, with higher scores indicating better quality of life. A negative change from baseline indicates a decrease in score.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the Physical Wellbeing Subscale as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score Change from Baseline to Day +100 post-HSCT	-1.25 unit on a scale Standard Deviation 5.069	-1.41 unit on a scale Standard Deviation 6.371
Change From Baseline to Days +100 and +180 Post-HSCT in the Physical Wellbeing Subscale as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score Change from Baseline to Day +180 post-HSCT	-1.55 unit on a scale Standard Deviation 5.230	-1.54 unit on a scale Standard Deviation 5.717

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) total score is the sum of the FACT physical wellbeing score, the FACT social/family wellbeing score, the FACT emotional wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. The FACT social/family wellbeing subscale scores range from a minimum of 0 to a maximum of 28, with higher scores indicating better quality of life. A negative change from baseline indicates a decrease in score.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the Social/Family Wellbeing Subscale as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +100 post-HSCT	-0.56 unit on a scale Standard Deviation 3.488	-0.29 unit on a scale Standard Deviation 5.716
Change From Baseline to Days +100 and +180 Post-HSCT in the Social/Family Wellbeing Subscale as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +180 post-HSCT	-0.78 unit on a scale Standard Deviation 4.085	-1.34 unit on a scale Standard Deviation 3.380

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) total score is the sum of the FACT physical wellbeing score, the FACT social/family wellbeing score, the FACT emotional wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. The FACT emotional wellbeing subscale scores range from a minimum of 0 to a maximum of 24, with higher scores indicating better quality of life.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the Emotional Wellbeing Subscale as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +100 post-HSCT	1.47 unit on a scale Standard Deviation 4.910	1.47 unit on a scale Standard Deviation 3.659
Change From Baseline to Days +100 and +180 Post-HSCT in the Emotional Wellbeing Subscale as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +180 post-HSCT	0.79 unit on a scale Standard Deviation 4.683	1.53 unit on a scale Standard Deviation 3.458

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) total score is the sum of the FACT physical wellbeing score, the FACT social/family wellbeing score, the FACT emotional wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. The FACT functional wellbeing subscale scores range from a minimum of 0 to a maximum of 28, with higher scores indicating better quality of life. A negative change from baseline indicates a decrease in score.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the Functional Wellbeing Subscale as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +100 post-HSCT	-1.71 unit on a scale Standard Deviation 5.622	-2.11 unit on a scale Standard Deviation 5.962
Change From Baseline to Days +100 and +180 Post-HSCT in the Functional Wellbeing Subscale as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +180 post-HSCT	-2.21 unit on a scale Standard Deviation 7.241	-0.95 unit on a scale Standard Deviation 6.627

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) total score is the sum of the FACT physical wellbeing score, the FACT social/family wellbeing score, the FACT emotional wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. The FACT-BMT subscale scores range from a minimum of 0 to a maximum of 40, with higher scores indicating better quality of life. A negative change from baseline indicates a decrease in score.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the Bone Marrow Transplantation Subscale (BMTS) as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +100 post-HSCT	-0.88 unit on a scale Standard Deviation 5.484	-2.14 unit on a scale Standard Deviation 5.900
Change From Baseline to Days +100 and +180 Post-HSCT in the Bone Marrow Transplantation Subscale (BMTS) as Measured by the FACT-BMT Questionnaire Score Change from Baseline to Day +180 post-HSCT	-2.33 unit on a scale Standard Deviation 7.037	-1.01 unit on a scale Standard Deviation 6.173

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The FACT-General (FACT-G) is a core component of the FACT-BMT, and includes 4 of the 5 subscales included in the FACT-BMT total score (FACT physical wellbeing score, FACT social/family wellbeing score, FACT emotional wellbeing score, the FACT functional wellbeing score). In line with this similarity, results of the FACT-G exhibited the same pattern as described for the FACT-BMT total score. The FACT-G scores range from a minimParticipants were age ≥16 years at baseline.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the General (FACT-G) Questionnaire Score Change from Baseline to Day +100 post-HSCT	-2.38 unit on a scale Standard Deviation 12.623	-1.74 unit on a scale Standard Deviation 15.623
Change From Baseline to Days +100 and +180 Post-HSCT in the General (FACT-G) Questionnaire Score Change from Baseline to Day +180 post-HSCT	-4.03 unit on a scale Standard Deviation 15.366	-1.33 unit on a scale Standard Deviation 13.613

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) total score is the sum of the FACT physical wellbeing score, the FACT social/family wellbeing score, the FACT emotional wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. The FACT-BMT total score range is from a minimum of 0 to a maximum of 148, with higher scores indicating better quality of life. A negative change from baseline indicates a decrease in score.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the FACT-BMT Total Score Change from Baseline to Day +180 post-HSCT	-6.38 unit on a scale Standard Deviation 21.358	-2.83 unit on a scale Standard Deviation 18.079
Change From Baseline to Days +100 and +180 Post-HSCT in the FACT-BMT Total Score Change from Baseline to Day +100 post-HSCT	-3.24 unit on a scale Standard Deviation 16.036	-3.70 unit on a scale Standard Deviation 19.854

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The FACT-BMT-TOI is defined as the sum of the FACT physical wellbeing score, the FACT functional wellbeing score, and the FACT-BMT subscale. Scores range from a minimum of 0 to a maximum of 96, with higher scores indicating better quality of life. A negative change from baseline indicates a decrease in score.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in the Functional Assessment of Cancer Therapy-Bone Marrow Transplant-Trial Outcomes Index (FACT-BMT-TOI) Change from Baseline to Day +100 post-HSCT	-3.88 unit on a scale Standard Deviation 13.110	-5.24 unit on a scale Standard Deviation 15.575
Change From Baseline to Days +100 and +180 Post-HSCT in the Functional Assessment of Cancer Therapy-Bone Marrow Transplant-Trial Outcomes Index (FACT-BMT-TOI) Change from Baseline to Day +180 post-HSCT	-6.99 unit on a scale Standard Deviation 17.393	-3.33 unit on a scale Standard Deviation 14.922

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The 5-Level EuroQol-5D health questionnaire (EQ-5D-5L) index value, which is country-specific, was only performed for participants in the US. The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Change from the baseline assessment to Days +100 and +180 post-HSCT in the index value was assessed. The index value total range is from a minimum value of -1 to a maximum value of +1. A higher EQ-5D-5L index value represents better quality of life (QoL), thus a positive change in the index value represents improved QoL.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in Participant Reported Outcomes Measured Based on the EQ-5D-5L Index Value for Health States Change from Baseline to Day +180 post-HSCT	0.02 unit on a scale Standard Deviation 0.078	-0.01 unit on a scale Standard Deviation 0.121
Change From Baseline to Days +100 and +180 Post-HSCT in Participant Reported Outcomes Measured Based on the EQ-5D-5L Index Value for Health States Change from Baseline to Day +100 post-HSCT	0.02 unit on a scale Standard Deviation 0.092	-0.01 unit on a scale Standard Deviation 0.101

SECONDARY outcome

Timeframe: Baseline through Days +100 and +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set were used in this analysis.

The EQ VAS score at baseline and each of the post-HSCT assessments was summarized and presented using descriptive statistics. A higher EQ VAS score represents better QoL. For each of the post-HSCT assessments, change between baseline and that assessment in the EQ VAS score was calculated similarly to the EQ-5D-5L index value for a specific participant and was summarized and presented using descriptive statistics. The score ranges from a minimum of 0 and a maximum of 100. A negative change in the score indicates a decrease in quality of life.

Outcome measures

Measure	Defibrotide Prophylaxis n=70 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=67 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Days +100 and +180 Post-HSCT in Participant Reported Outcomes as Measured Based on the EQ Visual Analog Scale (EQ VAS) Change from Baseline to Day +180 post-HSCT	2.24 unit on a scale Standard Deviation 29.023	-0.90 unit on a scale Standard Deviation 21.530
Change From Baseline to Days +100 and +180 Post-HSCT in Participant Reported Outcomes as Measured Based on the EQ Visual Analog Scale (EQ VAS) Change from Baseline to Day +100 post-HSCT	6.03 unit on a scale Standard Deviation 20.599	2.70 unit on a scale Standard Deviation 15.004

SECONDARY outcome

Timeframe: Baseline through Day +100 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +100 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=61 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=62 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Condition improved	3 Participants	4 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Unknown	19 Participants	15 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Condition unchanged	31 Participants	28 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Condition deteriorated	8 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline through Day +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +180 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=57 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=61 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Condition improved	3 Participants	3 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Unknown	17 Participants	19 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Condition unchanged	26 Participants	25 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Mobility Dimension for Participants With Age >=16 Years Condition deteriorated	11 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline through Day +100 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Days +100 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=61 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=62 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Unknown	19 Participants	15 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Condition improved	10 Participants	9 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Condition unchanged	18 Participants	20 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Condition deteriorated	14 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline through Day +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +180 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=57 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=61 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Unknown	17 Participants	19 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Condition improved	6 Participants	8 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Condition unchanged	23 Participants	20 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Pain/Discomfort Dimension for Participants With Age >=16 Years Condition deteriorated	11 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline through Day +100 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +100 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=61 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=62 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Unknown	19 Participants	15 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Condition improved	1 Participants	0 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Condition unchanged	34 Participants	37 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Condition deteriorated	7 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline through Day +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +180 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=57 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=61 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Condition improved	2 Participants	1 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Unknown	17 Participants	19 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Condition unchanged	34 Participants	31 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Self-Care Dimension for Participants With Age >=16 Years Condition deteriorated	4 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline through Day +100 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +100 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=61 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=62 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Condition improved	8 Participants	7 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Condition unchanged	21 Participants	22 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Condition deteriorated	13 Participants	18 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Unknown	19 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline through Day +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +180 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=57 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=61 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Condition deteriorated	14 Participants	18 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Condition improved	10 Participants	5 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Condition unchanged	16 Participants	19 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Usual Activities Dimension for Participants With Age >=16 Years Unknown	17 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline through Day +100 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +100 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=61 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=62 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Condition unchanged	27 Participants	30 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Condition deteriorated	8 Participants	7 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Unknown	19 Participants	15 Participants
Change From Baseline to Day +100 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Condition improved	7 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline through Day +180 post-HSCT

Population: Only participants with age \>=16 years at baseline in the Safety Analysis Set who were on the study at the time of the scheduled post-baseline assessment were included in the analysis.

The EQ-5D-5L is a standardized instrument for use as a measure of health outcome that includes a descriptive system consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of the 5 dimensions based on the descriptive system of the EQ-5D-5L, the numbers of participants for all categories (the 5 levels of reported problems) were assessed. For Day +180 Post-HSCT change between baseline in each dimension will be categorized as follows for a specific participant: Condition improved, if the reported level of problem is lower at that assessment than at baseline; Condition unchanged, if the reported level of problem remains the same; Condition deteriorated, if the reported level of problem is higher at that assessment than at baseline; Unknown, if the reported level of problem is not completed or missing either at baseline or at that assessment.

Outcome measures

Measure	Defibrotide Prophylaxis n=57 Participants Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=61 Participants Participants were administered Standard of Care immunoprophylaxis alone according to local institutional guidelines, physician preference, and patient need.
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Condition improved	8 Participants	12 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Condition unchanged	21 Participants	23 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Condition deteriorated	11 Participants	6 Participants
Change From Baseline to Day +180 Post-HSCT in 5-Level European Quality of Life (EQ-5D-5L) Anxiety/Depression Dimension for Participants With Age >=16 Years Unknown	17 Participants	20 Participants

Adverse Events

Defibrotide Prophylaxis

Serious events: 31 serious events

Other events: 74 other events

Deaths: 10 deaths

Standard of Care Immunoprophylaxis

Serious events: 31 serious events

Other events: 70 other events

Deaths: 9 deaths

Serious adverse events

Measure	Defibrotide Prophylaxis n=74 participants at risk Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=70 participants at risk Participants were administered Standard of Care immunoprophylaxis alone in a 1:1 ratio according to local institutional guidelines, physician preference, and patient need.
Vascular disorders Obstructive shock	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Vascular disorders Shock	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Vascular disorders Venoocclusive disease	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epstein-Barr virus associated lymphoproliferative disorder	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Immune system disorders Acute graft versus host disease	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Immune system disorders Acute graft versus host disease in skin	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Immune system disorders Graft versus host disease	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Immune system disorders Graft versus host disease in liver	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Immune system disorders Acute graft versus host disease in intestine	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders General physical health deterioration	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Mucosal haemorrhage	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Mucosal inflammation	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Multiple organ dysfunction syndrome	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Pyrexia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Transfusion reaction	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Blood potassium decreased	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Ejection fraction decreased	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Atrial flutter	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Cardiac tamponade	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Cardio-respiratory arrest	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Cardiogenic shock	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Sinus tachycardia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Stress cardiomyopathy	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Supraventricular tachycardia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Eosinophilia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Evans syndrome	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Febrile neutropenia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Thrombotic microangiopathy	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Cognitive disorder	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Syncope	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Abdominal pain	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Acute abdomen	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Diarrhoea	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Nausea	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Oesophagitis	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Stomatitis	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Vomiting	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Acute kidney injury	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Cystitis haemorrhagic	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Rash vesicular	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Toxic skin eruption	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Decreased appetite	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Dehydration	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Failure to thrive	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hyperkalaemia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypovolaemia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Arthritis bacterial	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Bacterial sepsis	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Bronchitis	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Clostridium difficile colitis	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Cystitis viral	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Cytomegalovirus infection	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Cytomegalovirus viraemia	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Device related infection	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Epstein-Barr viraemia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Epstein-Barr virus infection	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Fungaemia	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Respiratory tract infection	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Sepsis	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Septic shock	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Serratia infection	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Urinary tract infection	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Urinary tract infection bacterial	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Vascular device infection	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.

Other adverse events

Measure	Defibrotide Prophylaxis n=74 participants at risk Participants were administered Defibrotide Prophylaxis solution intravenously by study personnel at a dose of 25 mg/kg/day (6.25 mg/kg via 2-hour IV infusion every 6 hours) and Standard of Care immunoprophylaxis according to local institutional guidelines, physician preference, and patient need.	Standard of Care Immunoprophylaxis n=70 participants at risk Participants were administered Standard of Care immunoprophylaxis alone in a 1:1 ratio according to local institutional guidelines, physician preference, and patient need.
Vascular disorders Flushing	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Vascular disorders Hypertension	33.8% 25/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	41.4% 29/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Vascular disorders Hypotension	17.6% 13/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	15.7% 11/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Vascular disorders Orthostatic hypotension	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Immune system disorders Graft versus host disease in skin	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Asthenia	12.2% 9/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Catheter site pain	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Chills	9.5% 7/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Fatigue	33.8% 25/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	35.7% 25/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Mucosal inflammation	13.5% 10/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	24.3% 17/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Oedema peripheral	25.7% 19/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	30.0% 21/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Pain	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
General disorders Pyrexia	37.8% 28/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	34.3% 24/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Psychiatric disorders Agitation	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Psychiatric disorders Anxiety	14.9% 11/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Psychiatric disorders Confusional state	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Psychiatric disorders Delirium	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Psychiatric disorders Depression	9.5% 7/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Psychiatric disorders Insomnia	29.7% 22/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	22.9% 16/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Injury, poisoning and procedural complications Fall	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Injury, poisoning and procedural complications Infusion related reaction	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Injury, poisoning and procedural complications Limb injury	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Injury, poisoning and procedural complications Skin abrasion	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Alanine aminotransferase increased	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	10.0% 7/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Aspartate aminotransferase increased	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Bacterial test positive	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Blood bilirubin increased	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Blood creatinine increased	16.2% 12/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Blood magnesium decreased	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations C-reactive protein increased	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Epstein-Barr virus test positive	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Neutrophil count decreased	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	15.7% 11/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Platelet count decreased	25.7% 19/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	30.0% 21/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Transaminases increased	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations Weight decreased	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Investigations White blood cell count decreased	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Cardiac disorders Sinus tachycardia	12.2% 9/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	11.4% 8/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Cough	23.0% 17/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	22.9% 16/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	17.1% 12/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.2% 12/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	15.7% 11/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Hiccups	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.2% 9/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	17.1% 12/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Productive cough	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Rales	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Respiratory, thoracic and mediastinal disorders Tachypnoea	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Anaemia	36.5% 27/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	42.9% 30/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Febrile neutropenia	40.5% 30/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	28.6% 20/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Leukopenia	12.2% 9/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Neutropenia	16.2% 12/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	24.3% 17/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Blood and lymphatic system disorders Thrombocytopenia	25.7% 19/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	27.1% 19/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Dizziness	13.5% 10/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	11.4% 8/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Dysgeusia	13.5% 10/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Headache	41.9% 31/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	32.9% 23/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Restless legs syndrome	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Somnolence	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Nervous system disorders Tremor	13.5% 10/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Eye disorders Dry eye	20.3% 15/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Eye disorders Eye swelling	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Abdominal distension	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Abdominal pain	17.6% 13/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	31.4% 22/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Abdominal pain lower	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Abdominal pain upper	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Constipation	37.8% 28/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	41.4% 29/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Diarrhoea	63.5% 47/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	75.7% 53/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Dry mouth	9.5% 7/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Dyspepsia	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	15.7% 11/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Dysphagia	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Flatulence	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Haemorrhoids	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Mouth ulceration	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Nausea	75.7% 56/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	70.0% 49/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Odynophagia	9.5% 7/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Oesophagitis	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Stomatitis	56.8% 42/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	51.4% 36/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Gastrointestinal disorders Vomiting	52.7% 39/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	54.3% 38/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Acute kidney injury	23.0% 17/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	22.9% 16/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Cystitis haemorrhagic	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Dysuria	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Haematuria	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Pollakiuria	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Renal and urinary disorders Urinary retention	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	0.00% 0/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Alopecia	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Dry skin	9.5% 7/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	11.4% 8/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Erythema	17.6% 13/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	18.6% 13/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Petechiae	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Pruritus	14.9% 11/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	18.6% 13/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Pruritus generalised	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Rash	23.0% 17/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	27.1% 19/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.5% 7/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	10.0% 7/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Arthralgia	13.5% 10/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Back pain	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	17.1% 12/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Bone pain	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	1.4% 1/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Myalgia	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Neck pain	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Pain in extremity	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	4.3% 3/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Decreased appetite	40.5% 30/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	42.9% 30/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Dehydration	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Fluid overload	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Fluid retention	8.1% 6/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hyperglycaemia	16.2% 12/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	12.9% 9/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hyperkalaemia	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	11.4% 8/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypernatraemia	2.7% 2/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypoalbuminaemia	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	2.9% 2/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypocalcaemia	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypokalaemia	32.4% 24/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	38.6% 27/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypomagnesaemia	40.5% 30/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	50.0% 35/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hyponatraemia	10.8% 8/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypophagia	1.4% 1/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	7.1% 5/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Hypophosphataemia	6.8% 5/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	15.7% 11/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Metabolism and nutrition disorders Malnutrition	5.4% 4/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Clostridium difficile colitis	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	5.7% 4/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Cytomegalovirus infection	14.9% 11/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	20.0% 14/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Oral candidiasis	0.00% 0/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.
Infections and infestations Urinary tract infection	4.1% 3/74 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.	8.6% 6/70 • All Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported from the time of signed informed consent form (ICF) and were recorded up to Day +63 post-HSCT. SAEs considered by the investigator to be related to study drug or study procedures were reported up to Day +180 post-HSCT. Treatment-emergent adverse events (TEAEs) were defined as events that occurred after randomization into this study. A TEAE is defined as any event with a start date on or after baseline through the end of the study, or any ongoing event that worsens in severity after baseline through the end of the study. Adverse events were assessed using the Safety Analysis Set.

Additional Information

Director, Disclosure & Transparency

Jazz Pharmaceuticals

Phone: 215-870-9177

Email: ClinicalTrialDisclosure@JazzPharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
• Publication restrictions are in place

Restriction type: OTHER