Trial Outcomes & Findings for Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040) (NCT NCT03930615)

NCT ID: NCT03930615

Last Updated: 2024-08-22

Results Overview

Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV preemptive therapy (PET) with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Missing values were handled by the observed failure (OF) approach where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 (\~100 days) through week 28 post-transplant. It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection when LET prophylaxis is extended from 100 to 200 days.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 220 participants
• Primary outcome timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)
• Results posted on: 2024-08-22

Participant Flow

Cytomegalovirus (CMV)-seropositive recipients (R+) of a hematopoietic stem cell transplant (HSCT) who had received letermovir (LET) prophylaxis through Week 14 (~100 days) post-transplant and were at high risk for CMV infection and/or disease were enrolled in this study.

Participant milestones

Measure	Letermovir Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Overall Study STARTED	145	75
Overall Study Treated	144	74
Overall Study COMPLETED	118	63
Overall Study NOT COMPLETED	27	12

Reasons for withdrawal

Measure	Letermovir Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Overall Study Death	9	3
Overall Study Lost to Follow-up	1	2
Overall Study Physician Decision	3	4
Overall Study Withdrawal by Subject	13	2
Overall Study Not treated	1	1

Baseline Characteristics

Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)

Baseline characteristics by cohort

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.	Total n=218 Participants Total of all reporting groups
Age, Continuous	51.9 Years STANDARD_DEVIATION 14.3 • n=5 Participants	52.7 Years STANDARD_DEVIATION 12.9 • n=7 Participants	52.2 Years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	31 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	43 Participants n=7 Participants	135 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants	53 Participants n=7 Participants	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	13 Participants n=7 Participants	38 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	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	113 Participants n=5 Participants	60 Participants n=7 Participants	173 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Donor Stratum Haploidentical	45 Participants n=5 Participants	22 Participants n=7 Participants	67 Participants n=5 Participants
Donor Stratum Non-haploidentical	99 Participants n=5 Participants	52 Participants n=7 Participants	151 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV preemptive therapy (PET) with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Missing values were handled by the observed failure (OF) approach where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 (~100 days) through week 28 post-transplant. It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection when LET prophylaxis is extended from 100 to 200 days.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With Clinically Significant CMV Infection From Week 14 (~100 Days) Post-transplant Through Week 28 (~200 Days) Post-transplant	2.8 Percentage of participants	18.9 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention according to the study intervention they received.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants Experiencing ≥1 Adverse Events (AEs) From Week 14 (~100 Days) Post-transplant Through Week 28 (~200 Days) Post-transplant	88.9 Percentage of participants	93.2 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention according to the study intervention they received.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants Withdrawing From Study Drug Due to an AE From Week 14 (~100 Days) Post-transplant Through Week 28 (~200 Days) Post-transplant	4.9 Percentage of participants	1.4 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 38 post-transplant (approximately 24 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV PET with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Missing values were handled by the OF approach where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 (~100 days) through week 38 post-transplant.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With Clinically Significant CMV Infection From Week 14 Post-transplant Through Week 38 Post-transplant	14.6 Percentage of participants	20.3 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 48 post-transplant (approximately 34 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV PET with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Missing values were handled by the OF approach where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 (~100 days) through week 48 post-transplant.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With Clinically Significant CMV Infection From Week 14 Post-transplant Through Week 48 Post-transplant	14.6 Percentage of participants	20.3 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV PET with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically significant CMV infection is the elapsed time from transplant to the onset of CMV end-organ disease or to the initiation of anti-CMV PET. Time to onset was determined from the Kaplan-Meier method for censored data.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Time to Onset of Clinically Significant CMV Infection From Week 14 Post-transplant to Week 28 Post-transplant	NA Days NA means that due to the less than 50% incidence of clinically significant CMV infection, the median time was not reached.	NA Days NA means that due to the less than 50% incidence of clinically significant CMV infection, the median time was not reached.

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 48 post-transplant (approximately 34 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV PET with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically significant CMV infection is the elapsed time from transplant to the onset of CMV end-organ disease or to the initiation of anti-CMV PET. Time to onset was determined from the Kaplan-Meier method for censored data.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Time to Onset of Clinically Significant CMV Infection From Week 14 Post-transplant to Week 48 Post-transplant	NA Days NA means that due to the less than 50% incidence of clinically significant CMV infection, the median time was not reached.	NA Days NA means that due to the less than 50% incidence of clinically significant CMV infection, the median time was not reached.

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

The percentage of participants with CMV viremia who initiated PET of anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) was determined. Missing values were handled with the OF approach, where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 through week 28 post-transplant.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With CMV Viremia Who Started PET From Week 14 Post-transplant to Week 28 Post-transplant	2.1 Percentage of participants	16.2 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 48 post-transplant (approximately 34 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

The percentage of participants with CMV viremia who initiated PET of anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) was determined. Missing values were handled with the OF approach, where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 through week 48 post-transplant.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With CMV Viremia Who Started PET From Week 14 Post-transplant to Week 48 Post-transplant	13.2 Percentage of participants	18.9 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

The percentage of participants who died due to any cause (all-cause mortality) from Week 14 to Week 28 was determined.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With All-cause Mortality From Week 14 Post-transplant to Week 28 Post-transplant	2.1 Percentage of participants	1.4 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 48 post-transplant (approximately 34 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

The percentage of participants who died due to any cause (all-cause mortality) from Week 14 to Week 48 was determined.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Percentage of Participants With All-cause Mortality From Week 14 Post-transplant to Week 48 Post-transplant	8.3 Percentage of participants	8.1 Percentage of participants

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 28 post-transplant (approximately 14 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Time to all-cause mortality is the time elapsed after Week 14 post-transplant and death due to any cause, and was determined from the Kaplan-Meier method for censored data.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Time to All-cause Mortality From Week 14 Post-transplant to Week 28 Post-transplant	NA Days NA means that as participants were followed for less than a year after transplant, this was insufficient time to reach a median survival time.	NA Days NA means that as participants were followed for less than a year after transplant, this was insufficient time to reach a median survival time.

SECONDARY outcome

Timeframe: From Week 14 post-transplant to Week 48 post-transplant (approximately 34 weeks)

Population: All randomized participants who received at least 1 dose of study intervention.

Time to all-cause mortality is the time elapsed after Week 14 post-transplant and death due to any cause, and was determined from the Kaplan-Meier method for censored data.

Outcome measures

Measure	Letermovir n=144 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 Participants Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Time to All-cause Mortality From Week 14 Post-transplant to Week 48 Post-transplant	NA Days NA means that as participants were followed for less than a year after transplant, this was insufficient time to reach a median survival time.	NA Days NA means that as participants were followed for less than a year after transplant, this was insufficient time to reach a median survival time.

Adverse Events

Letermovir

Serious events: 49 serious events

Other events: 100 other events

Deaths: 16 deaths

Placebo

Serious events: 27 serious events

Other events: 58 other events

Deaths: 8 deaths

Serious adverse events

Measure	Letermovir n=144 participants at risk Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 participants at risk Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Blood and lymphatic system disorders Anaemia	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Blood and lymphatic system disorders Leukopenia	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Blood and lymphatic system disorders Neutropenia	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Blood and lymphatic system disorders Pure white cell aplasia	0.69% 1/144 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Cardiac disorders Cardiac failure congestive	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Cardiac disorders Pericarditis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Congenital, familial and genetic disorders Aplasia	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Endocrine disorders Thyroiditis subacute	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Diarrhoea	1.4% 2/144 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Haematochezia	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Intestinal perforation	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Stomatitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
General disorders Multiple organ dysfunction syndrome	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
General disorders Pyrexia	2.8% 4/144 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Immune system disorders Graft versus host disease	6.2% 9/144 • Number of events 9 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	8.1% 6/74 • Number of events 6 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Acute sinusitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Adenoviral haemorrhagic cystitis	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Adenovirus infection	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Anal abscess	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Appendicitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations COVID-19	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations COVID-19 pneumonia	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cellulitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cerebral toxoplasmosis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Clostridium difficile colitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cytomegalovirus chorioretinitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cytomegalovirus infection	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cytomegalovirus viraemia	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Escherichia infection	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Gastroenteritis viral	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Herpes simplex	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Human herpesvirus 6 infection	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Influenza	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Lower respiratory tract infection fungal	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Lymph node tuberculosis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Mastoiditis	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Myelitis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Neutropenic sepsis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumocystis jirovecii pneumonia	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia	2.8% 4/144 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	6.8% 5/74 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia aspiration	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia bacterial	1.4% 2/144 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia fungal	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia influenzal	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia klebsiella	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia pseudomonal	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pneumonia viral	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Pseudomonal sepsis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Rhinovirus infection	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Sepsis	1.4% 2/144 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Septic shock	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Staphylococcal infection	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Urinary tract infection	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Vascular device infection	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Viral upper respiratory tract infection	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Injury, poisoning and procedural complications Subdural haematoma	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Injury, poisoning and procedural complications Transplant failure	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Investigations Escherichia test positive	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Investigations Platelet count decreased	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Investigations Troponin increased	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Metabolism and nutrition disorders Hypoproteinaemia	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Musculoskeletal and connective tissue disorders Pathological fracture	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	1.4% 2/144 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	5.6% 8/144 • Number of events 8 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	4.1% 3/74 • Number of events 3 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large granular lymphocytosis	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified recurrent	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	1.4% 2/144 • Number of events 3 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Psychiatric disorders Confusional state	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Renal and urinary disorders Nephrolithiasis	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Reproductive system and breast disorders Heavy menstrual bleeding	0.69% 1/144 • Number of events 2 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	1.4% 1/74 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.69% 1/144 • Number of events 1 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	0.00% 0/74 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Other adverse events

Measure	Letermovir n=144 participants at risk Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of LET (480 mg once daily alone or 240 mg once daily for participants on cyclosporin A) treatment.	Placebo n=74 participants at risk Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment.
Blood and lymphatic system disorders Anaemia	5.6% 8/144 • Number of events 9 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	4.1% 3/74 • Number of events 3 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Diarrhoea	11.1% 16/144 • Number of events 19 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	14.9% 11/74 • Number of events 12 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Nausea	11.8% 17/144 • Number of events 19 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	20.3% 15/74 • Number of events 17 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Gastrointestinal disorders Vomiting	6.2% 9/144 • Number of events 10 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	4.1% 3/74 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
General disorders Fatigue	3.5% 5/144 • Number of events 6 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	6.8% 5/74 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
General disorders Oedema	0.00% 0/144 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
General disorders Oedema peripheral	8.3% 12/144 • Number of events 12 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	12.2% 9/74 • Number of events 10 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
General disorders Pyrexia	8.3% 12/144 • Number of events 13 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	12.2% 9/74 • Number of events 13 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Immune system disorders Graft versus host disease	31.2% 45/144 • Number of events 61 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	29.7% 22/74 • Number of events 34 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cytomegalovirus infection	2.1% 3/144 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Cytomegalovirus infection reactivation	4.2% 6/144 • Number of events 6 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	6.8% 5/74 • Number of events 6 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Infections and infestations Upper respiratory tract infection	4.2% 6/144 • Number of events 7 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	6.8% 5/74 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Investigations Alanine aminotransferase increased	3.5% 5/144 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Investigations Neutrophil count decreased	2.8% 4/144 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 6 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Metabolism and nutrition disorders Decreased appetite	4.2% 6/144 • Number of events 7 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	14.9% 11/74 • Number of events 13 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Metabolism and nutrition disorders Hypokalaemia	3.5% 5/144 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 6/144 • Number of events 6 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	6.8% 5/74 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Nervous system disorders Dizziness	2.1% 3/144 • Number of events 3 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 5 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Nervous system disorders Headache	6.9% 10/144 • Number of events 11 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	5.4% 4/74 • Number of events 4 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 8/144 • Number of events 8 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	12.2% 9/74 • Number of events 11 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 9/144 • Number of events 10 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	8.1% 6/74 • Number of events 7 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Skin and subcutaneous tissue disorders Pruritus	7.6% 11/144 • Number of events 11 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	2.7% 2/74 • Number of events 3 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Skin and subcutaneous tissue disorders Rash	6.2% 9/144 • Number of events 11 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	10.8% 8/74 • Number of events 8 • All-cause mortality: From 14 weeks post-transplant up to 48 weeks post-transplant (approximately 34 weeks); adverse events (AEs) and serious AEs (SAEs): From 14 weeks post-transplant up to 30 weeks post-transplant (approximately 16 weeks). The population analyzed for all-cause mortality (death due to any cause) was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER