NCT00676806 · ADVERSE EVENTS

Adverse events

A Phase II Study of Umbilical Cord Blood Transplantation · Source last updated 2017-06-01

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Myeloablative Conditioning Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 \& -5), fludarabine (25 mg/m2 days -7, -6, \& -5) and total body irradiation (days -3, -2, \& -1, total 1200 cGy) followed by cord blood infusion on day 0.	3 / 3	1 / 3	Not reported / Not reported
Reduced Intensity Conditioning Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 \& -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 \& -4), total body irradiation (days -3 \& -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.	3 / 3	0 / 3	Not reported / Not reported

Group identifiers: EG000: Myeloablative Conditioning · EG001: Reduced Intensity Conditioning

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
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Respiratory Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Lung Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Typhlitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Pulmonary Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Renal Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastrointestinal GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Bone marrow hypocellular

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
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Skin Nodules
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Likely d/t severe medical illness, renal failure, and medication
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Confusion

Complete source fields

event Groups

description
Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 \& -5), fludarabine (25 mg/m2 days -7, -6, \& -5) and total body irradiation (days -3, -2, \& -1, total 1200 cGy) followed by cord blood infusion on day 0.
id
EG000
other Num Affected
1
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Myeloablative Conditioning
description
Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 \& -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 \& -4), total body irradiation (days -3 \& -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0.
id
EG001
other Num Affected
0
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Reduced Intensity Conditioning

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Skin Nodules
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Likely d/t severe medical illness, renal failure, and medication
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Confusion

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Respiratory Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Lung Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
term
Typhlitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Pulmonary Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Renal Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Gastrointestinal GVHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Bone marrow hypocellular

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Preserved source evidence · Not medical advice