Trial Outcomes & Findings for Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201) (NCT NCT00075816)

NCT ID: NCT00075816

Last Updated: 2023-01-04

Results Overview

Overall survival rate at 2 years according to an intention-to-treat analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

551 participants

Primary outcome timeframe

Measured at 2 years

Results posted on

2023-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Bone Marrow Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.	Peripheral-Blood Stem Cells Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
Overall Study STARTED	278	273
Overall Study COMPLETED	264	262
Overall Study NOT COMPLETED	14	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Bone Marrow Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.	Peripheral-Blood Stem Cells Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
Overall Study Did not undergo transplantation	14	11

Baseline Characteristics

Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant in Individuals With Hematologic Cancers (BMT CTN 0201)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors	Total n=551 Participants Total of all reporting groups
Age, Customized 0-10 years	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Age, Customized 11-20 years	26 participants n=5 Participants	11 participants n=7 Participants	37 participants n=5 Participants
Age, Customized 21-30 years	42 participants n=5 Participants	45 participants n=7 Participants	87 participants n=5 Participants
Age, Customized 31-40 years	42 participants n=5 Participants	49 participants n=7 Participants	91 participants n=5 Participants
Age, Customized 41-50 years	52 participants n=5 Participants	55 participants n=7 Participants	107 participants n=5 Participants
Age, Customized 51-60 years	69 participants n=5 Participants	75 participants n=7 Participants	144 participants n=5 Participants
Age, Customized >=61 years	38 participants n=5 Participants	29 participants n=7 Participants	67 participants n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	127 Participants n=7 Participants	237 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	146 Participants n=7 Participants	314 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	258 Participants n=5 Participants	244 Participants n=7 Participants	502 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	250 Participants n=5 Participants	248 Participants n=7 Participants	498 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Diagnosis Acute myeloid leukemia	130 participants n=5 Participants	131 participants n=7 Participants	261 participants n=5 Participants
Diagnosis Acute lymphoblastic leukemia	61 participants n=5 Participants	56 participants n=7 Participants	117 participants n=5 Participants
Diagnosis Chronic myeloid leukemia	29 participants n=5 Participants	37 participants n=7 Participants	66 participants n=5 Participants
Diagnosis Myelodysplastic syndrome	52 participants n=5 Participants	41 participants n=7 Participants	93 participants n=5 Participants
Diagnosis Chronic myelomonocytic leukemia	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Diagnosis Myelofibrosis	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Karnofsky performance-status score 90-100%	172 participants n=5 Participants	154 participants n=7 Participants	326 participants n=5 Participants
Karnofsky performance-status score <90%	68 participants n=5 Participants	74 participants n=7 Participants	142 participants n=5 Participants
Karnofsky performance-status score Unknown	38 participants n=5 Participants	45 participants n=7 Participants	83 participants n=5 Participants
Cytomegalovirus serologic testing Seropositivity for CMV	142 participants n=5 Participants	123 participants n=7 Participants	265 participants n=5 Participants
Cytomegalovirus serologic testing Seronegativity for CMV	121 participants n=5 Participants	138 participants n=7 Participants	259 participants n=5 Participants
Cytomegalovirus serologic testing Unknown	15 participants n=5 Participants	12 participants n=7 Participants	27 participants n=5 Participants
Conditioning regimen Cyclophosphamide and total-body irradiation	133 participants n=5 Participants	133 participants n=7 Participants	266 participants n=5 Participants
Conditioning regimen Cyclophosphamide and busulfan	90 participants n=5 Participants	75 participants n=7 Participants	165 participants n=5 Participants
Conditioning regimen Fludarabine, busulfan, and antithymocyte globulin	39 participants n=5 Participants	40 participants n=7 Participants	79 participants n=5 Participants
Conditioning regimen Fludarabine and melphalan	16 participants n=5 Participants	25 participants n=7 Participants	41 participants n=5 Participants
GVHD prophylaxis Cyclosporine and methotrexate	67 participants n=5 Participants	59 participants n=7 Participants	126 participants n=5 Participants
GVHD prophylaxis Tacrolimus and methotrexate	183 participants n=5 Participants	196 participants n=7 Participants	379 participants n=5 Participants
GVHD prophylaxis Other	28 participants n=5 Participants	18 participants n=7 Participants	46 participants n=5 Participants
Transplantation patients Underwent transplantation	264 participants n=5 Participants	262 participants n=7 Participants	526 participants n=5 Participants
Transplantation patients Did not undergo transplantation	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants
Antithymocyte globulin treatment Antithymocyte globulin treatment	65 participants n=5 Participants	72 participants n=7 Participants	137 participants n=5 Participants
Antithymocyte globulin treatment No Antithymocyte globulin treatment	193 participants n=5 Participants	183 participants n=7 Participants	376 participants n=5 Participants
Antithymocyte globulin treatment Unknown	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
Number of donor mismatches at HLA-A, B, C, and DRB1 0	200 participants n=5 Participants	209 participants n=7 Participants	409 participants n=5 Participants
Number of donor mismatches at HLA-A, B, C, and DRB1 1	55 participants n=5 Participants	50 participants n=7 Participants	105 participants n=5 Participants
Number of donor mismatches at HLA-A, B, C, and DRB1 2	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Number of donor mismatches at HLA-A, B, C, and DRB1 3	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Number of donor mismatches at HLA-A, B, C, and DRB1 Missing	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants
CD34+ cell dose per kilogram (x10^-6)	2.75 cell dose per kilogram (x10^-6) n=5 Participants	7.70 cell dose per kilogram (x10^-6) n=7 Participants	5.23 cell dose per kilogram (x10^-6) n=5 Participants

PRIMARY outcome

Timeframe: Measured at 2 years

Overall survival rate at 2 years according to an intention-to-treat analysis.

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Two-year Overall Survival	46 percentage of patients Interval 40.0 to 52.0	51 percentage of patients Interval 45.0 to 57.0

SECONDARY outcome

Timeframe: Measured at Day 28

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Neutrophil Engraftment	87 percentage of patients	97 percentage of patients

SECONDARY outcome

Timeframe: Measured at Day 180

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Platelet Engraftment Platelet engraftment >20K from time of transplant	85.8 percentage of patients Interval 75.3 to 92.0	91.6 percentage of patients Interval 78.9 to 96.8
Platelet Engraftment Platelet engraftment >50K from time of transplant	80.3 percentage of patients Interval 70.3 to 87.2	86.7 percentage of patients Interval 76.2 to 92.8

SECONDARY outcome

Timeframe: Measured at 28 and 100 days

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=274 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Graft Failure	9 percentage of patients Interval 6.0 to 13.0	3 percentage of patients Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Measured at 730 days

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Extensive Chronic Graft-versus-host Disease (GVHD)	32 percentage of patients Interval 26.0 to 38.0	48 percentage of patients Interval 42.0 to 54.0

SECONDARY outcome

Timeframe: Measured at 2 years

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Chronic GVHD	41 percentage of participants Interval 34.0 to 48.0	53 percentage of participants Interval 45.0 to 61.0

SECONDARY outcome

Timeframe: Measured at 2 years

Analysis restricted to patients who received the transplant.

Outcome measures

Outcome measures
Measure	Bone Marrow n=264 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=262 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Relapse	28.9 percentage of patients Interval 23.3 to 34.7	27.5 percentage of patients Interval 22.1 to 33.2

SECONDARY outcome

Timeframe: Measured at 1 and 2 years

Population: Analysis restricted to patients who received the transplant.

Number of infection reports per patient.

Outcome measures

Outcome measures
Measure	Bone Marrow n=264 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=262 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Infections 0 infections	49 participants	68 participants
Infections 1 infection	52 participants	50 participants
Infections 2 infections	46 participants	48 participants
Infections 3 infections	30 participants	25 participants
Infections 4 infections	26 participants	17 participants
Infections 5 infections	18 participants	16 participants
Infections 6 infections	11 participants	8 participants
Infections >6 infections	32 participants	30 participants

SECONDARY outcome

Timeframe: Measured by 2 years

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Grades III-V Unexpected Adverse Events Pulmonary/dyspnea	1 participants	0 participants
Grades III-V Unexpected Adverse Events Pericarditis with pericardial effusion	1 participants	0 participants
Grades III-V Unexpected Adverse Events Myocardial infarction	1 participants	1 participants
Grades III-V Unexpected Adverse Events Malignancy: skin squamous cell CA	1 participants	0 participants
Grades III-V Unexpected Adverse Events Acute renal failure	1 participants	0 participants
Grades III-V Unexpected Adverse Events R portal vein obstruction	1 participants	0 participants
Grades III-V Unexpected Adverse Events Right side pulmonary embolus	1 participants	1 participants
Grades III-V Unexpected Adverse Events Facial trauma - fractured L lamina	1 participants	0 participants
Grades III-V Unexpected Adverse Events Pulmonary embolism	1 participants	1 participants
Grades III-V Unexpected Adverse Events Blindness	1 participants	0 participants
Grades III-V Unexpected Adverse Events Confusion	1 participants	0 participants
Grades III-V Unexpected Adverse Events Intra-abdominal hemorrhage	1 participants	0 participants
Grades III-V Unexpected Adverse Events Death	1 participants	0 participants
Grades III-V Unexpected Adverse Events Altered mental status	1 participants	0 participants
Grades III-V Unexpected Adverse Events Pneumonia	1 participants	0 participants
Grades III-V Unexpected Adverse Events Vascular: pulmonary embolus	0 participants	1 participants
Grades III-V Unexpected Adverse Events Sudden death	0 participants	1 participants
Grades III-V Unexpected Adverse Events Hypertensive crisis	0 participants	1 participants
Grades III-V Unexpected Adverse Events Elevated LFT S	0 participants	1 participants
Grades III-V Unexpected Adverse Events Hemolytic transfusion reaction	0 participants	1 participants
Grades III-V Unexpected Adverse Events Confusion, dehydration, hygroma	0 participants	1 participants
Grades III-V Unexpected Adverse Events Respiratory decompensation	0 participants	1 participants
Grades III-V Unexpected Adverse Events Retinal tear	0 participants	1 participants
Grades III-V Unexpected Adverse Events Retinopathy both eyes	0 participants	1 participants

SECONDARY outcome

Timeframe: 100 days, 180 days

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Acute GVHD Grade II-IV 100 days from transplantation	45.6 percentage of patients Interval 39.1 to 51.9	46.7 percentage of patients Interval 40.2 to 53.0
Acute GVHD Grade II-IV 180 days from transplantation	50 percentage of patients Interval 43.1 to 56.4	51 percentage of patients Interval 44.2 to 57.4

SECONDARY outcome

Timeframe: 100 days, 180 days

Outcome measures

Outcome measures
Measure	Bone Marrow n=278 Participants Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=273 Participants Peripheral blood stem cell transplant from HLA compatible unrelated donors
Acute GVHD Grade III-IV 100 days from transplantation	13.8 percentage of patients Interval 9.9 to 18.2	16.4 percentage of patients Interval 12.2 to 21.2
Acute GVHD Grade III-IV 180 days from transplantation	14.9 percentage of patients Interval 10.9 to 19.6	18.8 percentage of patients Interval 14.3 to 23.8

SECONDARY outcome

Timeframe: Measured at 2 years

Bone Marrow

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Peripheral-Blood Stem Cells

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Adam Mendizabal

The EMMES Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bone Marrow n=260 participants at risk Bone marrow transplant from HLA compatible unrelated donors	Peripheral-Blood Stem Cells n=261 participants at risk Peripheral blood stem cell transplant from HLA compatible unrelated donors
Cardiac disorders Myocardial infarction	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Cardiac disorders Pericarditis	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Eye disorders Blindness	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Eye disorders Retinal tear	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Eye disorders Retinopathy	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
General disorders Death	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
General disorders Sudden death	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Hepatobiliary disorders Portal vein occlusion	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Infections and infestations Pneumonia	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Injury, poisoning and procedural complications Facial bones fracture	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Investigations Hepatic enzyme increased	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Psychiatric disorders Confusional state	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Renal and urinary disorders Renal failure acute	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.38% 1/260 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.00% 0/261 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.77% 2/260 • Number of events 2 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	1.1% 3/261 • Number of events 3 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.
Vascular disorders Hypertensive crisis	0.00% 0/260 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.	0.38% 1/261 • Number of events 1 • 3-years post-transplant Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected adverse events are reported here.