NCT02158052 · ADVERSE EVENTS

Adverse events

Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease · Source last updated 2022-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 6 years
Other-event reporting threshold: 5%

Adverse event information was assessed by study investigators and entered into an internal Bone Marrow Transplant database.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bone Marrow and Kidney RECIPIENT Single arm combined bone marrow and kidney transplantation Tacrolimus: Tacrolimus starting on Day -1 Equine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3 Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Total body irradiation 400 centigray (200 cGy X 2): On transplant day -1	1 / 1	1 / 1	0 / 1
Bone Marrow and Kidney DONOR Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure.	0 / 1	0 / 1	0 / 1

Group identifiers: EG000: Bone Marrow and Kidney RECIPIENT · EG001: Bone Marrow and Kidney DONOR

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transient acute kidney injury due to tacrolimus and engraftment syndrome
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Delayed (secondary) hematopoietic graft rejection. A second HLA-matched related stem cell transplant was performed from the same donor on 5/11/16 with successful and sustained engraftment.
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Hematopoietic graft rejection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Pulmonary aspergillosis following hematopoietic graft rejection, treated to resolution following a second hematopoietic cell transplant from the same donor and anti-fungal therapy
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Aspergillosis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
A postoperative transient perinephric hematoma occurred, not requiring surgical intervention.
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Perinephric hematoma
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Abdominal pain due to constipation occurred which was alleviated by a bowel regimen.
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Abdominal pain

Complete source fields

description

Adverse event information was assessed by study investigators and entered into an internal Bone Marrow Transplant database.

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Single arm combined bone marrow and kidney transplantation Tacrolimus: Tacrolimus starting on Day -1 Equine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3 Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Total body irradiation 400 centigray (200 cGy X 2): On transplant day -1
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Bone Marrow and Kidney RECIPIENT
deaths Num Affected
0
deaths Num At Risk
1
description
Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure.
id
EG001
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Bone Marrow and Kidney DONOR

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
A postoperative transient perinephric hematoma occurred, not requiring surgical intervention.
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Perinephric hematoma
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Abdominal pain due to constipation occurred which was alleviated by a bowel regimen.
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Transient acute kidney injury due to tacrolimus and engraftment syndrome
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Delayed (secondary) hematopoietic graft rejection. A second HLA-matched related stem cell transplant was performed from the same donor on 5/11/16 with successful and sustained engraftment.
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Hematopoietic graft rejection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Pulmonary aspergillosis following hematopoietic graft rejection, treated to resolution following a second hematopoietic cell transplant from the same donor and anti-fungal therapy
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num At Risk
1
term
Aspergillosis

time Frame

6 years

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Preserved source evidence · Not medical advice