Trial Outcomes & Findings for B Cell Induction in Pediatric Lung Transplantation (NCT NCT02266888)

Last Updated: 2021-10-26

Results Overview

This composite outcome measures is defined as the earliest time post-transplant to any of the following events during the follow-up period: * Chronic Allograft Dysfunction (defined as the occurrence of confirmed Bronchiolitis Obliterans Syndrome (BOS) grade 0-p or higher or a diagnosis of Obliterative Bronchiolitis (OB)), * Listed for re-transplant (e.g., second lung transplant), or * Death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to 35 months post-transplant

Results posted on

2021-10-26

Participant Flow

Seven sites in the United States enrolled 45 participants into this trial.

Participant milestones

Participant milestones
Measure	Rituximab Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Discontinued Pre-Transplant Participants who enrolled, but withdrew from the study prior to receiving a transplant.	Discontinued Pre-Randomization Participants who were enrolled and transplanted on study, but withdrew from the study prior to randomization.
Overall Study STARTED	15	12	11	7
Overall Study COMPLETED	8	8	0	0
Overall Study NOT COMPLETED	7	4	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Discontinued Pre-Transplant Participants who enrolled, but withdrew from the study prior to receiving a transplant.	Discontinued Pre-Randomization Participants who were enrolled and transplanted on study, but withdrew from the study prior to randomization.
Overall Study Death	2	2	4	2
Overall Study Physician Decision	0	1	2	2
Overall Study Study Terminated	5	1	0	0
Overall Study No Longer Eligible	0	0	0	2
Overall Study Randomization Closed	0	0	4	0
Overall Study Personnel unavailable at transplant	0	0	0	1
Overall Study Transfer of care	0	0	1	0

Baseline Characteristics

B Cell Induction in Pediatric Lung Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	12.5 years STANDARD_DEVIATION 4.55 • n=5 Participants	13.2 years STANDARD_DEVIATION 4.47 • n=7 Participants	12.8 years STANDARD_DEVIATION 4.44 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Pre-Transplant Lung Allocation Score (LAS) Diagnosis Group Group A	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Pre-Transplant Lung Allocation Score (LAS) Diagnosis Group Group B	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Pre-Transplant Lung Allocation Score (LAS) Diagnosis Group Group C	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Pre-Transplant Lung Allocation Score (LAS) Diagnosis Group Group D	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Donor and Recipient Gender Female Donor, Female Recipient	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Donor and Recipient Gender Female Donor, Male Recipient	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Donor and Recipient Gender Male Donor, Female Recipient	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Donor and Recipient Gender Male Donor, Male Recipient	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 35 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Earliest Time to Any of the Following Events: Chronic Allograft Dysfunction, Listed for Retransplant or Death	NA Days The median time to event was not reached due to insufficient number of events. Data is not estimable.	703 Days Interval 306.0 to The upper confidence limit is not estimable since no events occurred after reaching median survival.

SECONDARY outcome

Timeframe: Up to 35 months post-transplant

Population: Intent-to-treat population included all randomized participants who 1.) Received at least a portion of the initial rituximab or placebo infusion and 2.) Had at least one biopsy evaluable for OB and sufficient pulmonary function tests for evaluation of BOS.

Chronic allograft dysfunction is defined as Bronchiolitis Obliterans Syndrome (BOS) ≥Grade 0p according to the International Society for Heart and Lung Transplantation (ISHLT) criteria, or biopsy proven histologic evidence of obliterans bronchiolitis. BOS is an indicator of post-transplant loss of lung function, a sign of allograft dysfunction that presents as a persistent decline in forced expiratory volume in 1 second (FEV1) or forced expiratory flow (FEF) 25-75% (often accompanied by evidence of airway obstruction) that is not the result of other causes such as acute rejection, acute infection, and/or airway stenosis. * BOS grade: Spirometry % of baseline * 0: FEV1 \>90% and FEF25-75% \>75% * 0-p: FEV1 81-90% and FEF25-75% ≤75% * 1: FEV1 66-80% * 2: FEV1 51-65% * 3: FEV1 ≤50%

Outcome measures

Outcome measures
Measure	Rituximab n=14 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=11 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Diagnosed With Chronic Allograft Dysfunction	28.6 Percent of Participants Interval 8.7 to 48.4	27.3 Percent of Participants Interval 5.2 to 49.4

SECONDARY outcome

Timeframe: Up to 35 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

Participants with a reported date of listing for a second lung transplant during the study follow-up period.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Listed for Re-Transplant During the Study Follow-Up Period	0 Percent of Participants Interval 0.0 to 0.0	8.3 Percent of Participants Interval 0.0 to 21.5

SECONDARY outcome

Timeframe: Up to 35 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

Participants with a reported date of death were considered to have met this outcome.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Who Died During the Study Follow-Up Period	13.3 Percent of Participants Interval 0.0 to 27.8	25.0 Percent of Participants Interval 4.4 to 45.6

SECONDARY outcome

Timeframe: Up to 72 hours post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion and had available blood gas (e.g., arterial oxygen pressure) data during the first 72 hours post-transplant.

The International Society for Heart and Lung Transplantation's (ISHLT) grading for Primary Graft Dysfunction (PGD) was used. The severity of PGD is graded 0 - 3 based on the presence or absence of diffuse opacities on chest radiograph and the ratio of arterial oxygen pressure to inspired oxygen concentration. The grading system predicts post-lung transplant outcomes with Grade 3 being the worse. Participants were classified as having PGD if graded as 2 or 3 at any time during the first 72 hours post-transplant.

Outcome measures

Outcome measures
Measure	Rituximab n=12 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=7 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants With Primary Graft Dysfunction (PGD)	25.0 Percent of Participants Interval 4.4 to 45.6	14.3 Percent of Participants Interval 0.0 to 36.0

SECONDARY outcome

Timeframe: Up to 24 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

Pulmonary allograft rejection was defined according to the 2007 International Society for Heart and Lung Transplantation's (ISHLT). Each transbronchial biopsy (TBBx) was evaluated by the local center's pathologist and graded as described below. Acute Cellular Rejection (ACR) Grade Classification: * A0: None * A1: Minimal * A2: Mild * A3: Moderate * A4: Severe Participants met this outcome if at any point in time their biopsy was classified as A2, A3, or A4.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants With Occurrence of Grade A Acute Rejection	13.3 Percent of Participants Interval 0.0 to 27.8	16.7 Percent of Participants Interval 0.0 to 34.4

SECONDARY outcome

Timeframe: Up to 24 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

Antibody Mediated Rejection (AMR) was defined based on the revision of the 1996 Working Formulation for the Standardization of Nomenclature in the Diagnosis of Lung Rejection, the Pathology of pulmonary AMR and the 2012 update from the Pathology Council of the International Society for Heart and Lung Transplantation (ISHLT). AMR was diagnosed locally and graded as: * Grade I: Latent humoral response - Donor Specific Antibody (DSA) or autoantibody present and absence of both abnormal histology and unexplained graft dysfunction * Grade II: Subclinical humoral rejection - DSA or autoantibody present and abnormal histology present with an absence of unexplained graft dysfunction * Grade III: Humoral rejection - DSA or autoantibody present and abnormal histology present and unexplained graft dysfunction present. Higher grades indicate more severe AMR. Participants were considered to have met this outcome if at any point in time their biopsy was classified as Grade II or III.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants With Occurrence of Antibody Mediated Rejection	0 Percent of Participants Interval 0.0 to 0.0	16.7 Percent of Participants Interval 0.0 to 34.4

SECONDARY outcome

Timeframe: Up to 24 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion and who had at least 3 outpatient tacrolimus trough levels collected that were at least 3 months post-transplant.

Tacrolimus trough levels are generally collected post-transplant to allow clinicians to monitor transplant recipients' adherence to prescribed tacrolimus dosing. This outcome was designed for research purposes as an indicator of adherence to tacrolimus over time. Beginning at 3 months post-transplant, a rolling standard deviation (SD) was estimated for each participant who had at least 3 outpatient trough levels collected and recorded. The estimated SD could derive from up to 1 year worth of trough levels at any given time. The larger the SD (variation) of tacrolimus levels, the greater the nonadherence of participant(s) taking tacrolimus as prescribed. Nonadherence is a major reason for post-transplant morbidity. Participants were considered to have met this outcome, the tacrolimus variability threshold, if their estimated SD of tacrolimus medication levels at any time was 2.0 ng/mL or greater.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=11 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Meeting Tacrolimus Variability Threshold	93.3 Percent of Participants Interval 82.7 to 100.0	100 Percent of Participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Up to 27 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion, which was subset to participants who qualified for and agreed to participate in the TVI.

For participants who met the Tacrolimus Variability Threshold and agreed to participate in the Tacrolimus Variability Intervention (TVI), a series of calls with the participant, parent(s)/guardian(s), and trained call center personnel were conducted to address barriers to adherence. Refer to Outcome Measure 8 for a description of tacrolimus variability threshold methodology.

Outcome measures

Outcome measures
Measure	Rituximab n=7 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=8 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Meeting Tacrolimus Variability Threshold Who Completed Tacrolimus Variability Intervention	85.7 Percent of Participants Interval 64.0 to 100.0	100 Percent of Participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Up to 19 months post-transplant

Standard deviation (SD) is a number that describes how a group of measurements are spread out around the average value for that group. A low SD value means the numbers are close to the average; a high SD means the numbers are more spread out. The change in SD of tacrolimus levels was calculated by subtracting each participant's pre-intervention SD from their SD 180 days after enrollment into the intervention (i.e., value of SD 180 days after enrollment minus value of SD before enrollment). A change less than zero (i.e., a negative number) would indicate a decrease in SD, which is good, possibly as a result of the intervention.

Outcome measures

Outcome measures
Measure	Rituximab n=7 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=7 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Magnitude of Change in Standard Deviation of Tacrolimus Levels Following Intervention Pre-TVI enrollment	3.95 Standard deviation per participant Standard Deviation 1.664	5.18 Standard deviation per participant Standard Deviation 2.423
Magnitude of Change in Standard Deviation of Tacrolimus Levels Following Intervention 180 Days after TVI enrollment	3.03 Standard deviation per participant Standard Deviation 0.948	2.86 Standard deviation per participant Standard Deviation 1.636

SECONDARY outcome

Timeframe: Up to 24 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

Defined by: * A local report of bacterial, fungal, or viral infection through either the organism specific case report form (CRF) or adverse event reporting; or * Presence of symptoms at the time of a study visit without a local report of infection but with a corresponding Core Lab identified viral infection * All symptoms reported at the time of a study visit were evaluated for any Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) infections identified by the Core Lab * For any other infections identified in Core Lab Nasopharyngeal (NP) and Bronchoalveolar Lavage (BAL) biospecimens: shortness of breath, new x-ray or other imaging finding, new supplemental oxygen requirement, cough with sputum, and decreased spirometry were evaluated signs/symptoms. Participants were considered to have met this outcome if at any point in time they had an infection meeting the referenced criteria.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Experiencing an Infection Episode	100 Percent of Participants	100 Percent of Participants

SECONDARY outcome

Timeframe: Up to 24 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

The severity of infection episodes was determined by the site Principal Investigator (PI) using the adverse event (AE) scale of mild to moderate (Grade \<3), severe (Grade 3), life-threatening (Grade 4), or fatal (Grade 5). Since the protocol restricted AE reporting to only those events which met National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 grading criteria of Grade 3 (moderate) or higher, any infection not reported as an AE was assigned a severity of Grade \<3 (effectively combining Grades 1 and 2); all other infections utilized the assigned CTCAE severity grade of the corresponding AE. A higher severity grade indicates a more severe event.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Number of Participants With Severity of Infection Episodes Grade < 3 (Mild to Moderate)	4 Participants	4 Participants
Number of Participants With Severity of Infection Episodes Grade 3 (Severe)	8 Participants	7 Participants
Number of Participants With Severity of Infection Episodes Grade 4 (Life-threatening or Disabling)	1 Participants	0 Participants
Number of Participants With Severity of Infection Episodes Grade 5 (Fatal)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 35 months post-transplant

Population: Intent-to-treat population included all randomized participants who received at least a portion of the initial rituximab or placebo infusion.

The percentage of participants with Serious Adverse Events (SAEs) as determined by the trial's medical monitor to be related to rituximab is reported.

Outcome measures

Outcome measures
Measure	Rituximab n=15 Participants Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 Participants Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.
Percent of Participants Experiencing a Serious Adverse Event (SAE) Related to Rituximab	73.3 Percent of Participants Interval 54.6 to 92.1	58.3 Percent of Participants Interval 34.9 to 81.7

Adverse Events

Rituximab

Serious events: 13 serious events

Other events: 6 other events

Deaths: 2 deaths

Placebo

Serious events: 9 serious events

Other events: 4 other events

Deaths: 3 deaths

Discontinued Pre-Transplant

Serious events: 3 serious events

Other events: 0 other events

Deaths: 4 deaths

Discontinued Pre-Randomization

Serious events: 3 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Rituximab n=15 participants at risk Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 participants at risk Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Discontinued Pre-Transplant n=11 participants at risk Subjects who enrolled, but withdrew from the study prior to receiving a transplant.	Discontinued Pre-Randomization n=7 participants at risk Subjects who were enrolled and transplanted on study, but withdrew from the study prior to randomization.
Blood and lymphatic system disorders Anaemia	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Cardiac disorders Atrial tachycardia	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Cardiac disorders Cardiac arrest	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	9.1% 1/11 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Constipation	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Distal ileal obstruction syndrome	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 2 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Distal intestinal obstruction syndrome	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Intestinal obstruction	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Hepatobiliary disorders Cholecystitis	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Immune system disorders Transplant rejection	13.3% 2/15 • Number of events 2 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	25.0% 3/12 • Number of events 3 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Arthritis bacterial	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Arthritis infective	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Bacterial infection	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Bronchitis	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Chronic sinusitis	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Corona virus infection	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Gastroenteritis	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Lower respiratory tract infection	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Nocardiosis	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Pharyngitis	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Pneumonia	26.7% 4/15 • Number of events 5 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	33.3% 4/12 • Number of events 5 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Pneumonia bacterial	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 2 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Pseudomonas infection	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Respiratory syncytial virus infection	13.3% 2/15 • Number of events 2 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	16.7% 2/12 • Number of events 2 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Respiratory tract infection	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Rhinovirus infection	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Septic shock	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Sinusitis	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Upper respiratory tract infection	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Urinary tract infection	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Wound infection	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Injury, poisoning and procedural complications Complications of transplant surgery	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	9.1% 1/11 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	42.9% 3/7 • Number of events 3 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Injury, poisoning and procedural complications Transplant dysfunction	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Investigations Blood glucose increased	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Investigations Lymphocyte count decreased	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.

Other adverse events
Measure	Rituximab n=15 participants at risk Induction: Rituximab was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Placebo n=12 participants at risk Induction: Rituximab placebo was administered in two 375 mg/m\^2 doses: on Day 0 within 12 hours of return to ICU following transplant and on Day 12 (+/-2 days). Standard of care immunosuppression (thymoglobulin induction, tacrolimus or equivalent, MMF or equivalent, and steroids) was also utilized at each site.	Discontinued Pre-Transplant n=11 participants at risk Subjects who enrolled, but withdrew from the study prior to receiving a transplant.	Discontinued Pre-Randomization n=7 participants at risk Subjects who were enrolled and transplanted on study, but withdrew from the study prior to randomization.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Gastrointestinal disorders Ileus	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
General disorders Fatigue	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
General disorders Influenza like illness	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Immune system disorders Transplant rejection	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Clostridium difficile infection	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Gastroenteritis clostridial	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Otitis media	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Pneumonia	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Sexually transmitted disease	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Infections and infestations Tracheitis	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Injury, poisoning and procedural complications Procedural haemorrhage	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Investigations Lymphocyte count decreased	13.3% 2/15 • Number of events 2 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Nervous system disorders Convulsion	0.00% 0/15 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	8.3% 1/12 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Nervous system disorders Headache	6.7% 1/15 • Number of events 1 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/12 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/11 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.	0.00% 0/7 • Up to 35 months post-transplant Only adverse events grade 3 or higher were collected. Information was recorded by the site on the AE/SAE electronic Case Report Form (eCRF). All SAEs were to be reported within 24 hours of awareness, regardless of relationship to study procedures/therapy or expectedness of the event. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.