NCT00719849 · ADVERSE EVENTS

Adverse events

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease · Source last updated 2017-06-14

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
Cyclophosphamide/Fludarabine/TBI Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil	3 / 4	2 / 4	Not reported / Not reported
Cyclophosphamide/Fludarabine/TBI/ATG Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 * Equine ATG 30mg/Kg Days -6 to -4 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil	8 / 9	3 / 9	Not reported / Not reported

Group identifiers: EG000: Cyclophosphamide/Fludarabine/TBI · EG001: Cyclophosphamide/Fludarabine/TBI/ATG

Serious adverse events

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

organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
8
num At Risk
9
num Events
8
term
Death
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
5
num At Risk
9
num Events
5
term
Relapse of underlying disease
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Congestive heart failure
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
MSOF leading to death
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
3
num At Risk
9
num Events
3
term
Fever of unknown etiology
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Allergic reaction
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Myopathy
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Creatinine Phosphokinase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Diarrhea
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Infection with grade 3 ANC - blood
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Infection with grade 3 ANC - lungs
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
ARDS

Other reported adverse events

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

organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Acidosis
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
term
Glucose, serum-high
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Potassium, serum-high
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Potassium, serum-low
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Sodium, serum-low
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
term
Lymphopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
term
Platelets
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Thrombus
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Phosphate, serum-low
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Magnesium, serum-high
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Hemoglobin
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Neutrophils

Complete source fields

event Groups

description
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
id
EG000
other Num Affected
2
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
Cyclophosphamide/Fludarabine/TBI
description
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months. * Cyclophosphamide 50 mg/Kg Day -6 * Fludarabine 40mg/m2 Days -6 to -2 * TBI 200 cGy Day -1 * Equine ATG 30mg/Kg Days -6 to -4 Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
id
EG001
other Num Affected
3
other Num At Risk
9
serious Num Affected
8
serious Num At Risk
9
title
Cyclophosphamide/Fludarabine/TBI/ATG

frequency Threshold

other Events

organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Acidosis
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
term
Glucose, serum-high
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Potassium, serum-high
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Potassium, serum-low
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Sodium, serum-low
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
term
Lymphopenia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
9
num Events
2
term
Platelets
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Thrombus
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Phosphate, serum-low
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Magnesium, serum-high
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Hemoglobin
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Neutrophils

serious Events

organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
8
num At Risk
9
num Events
8
term
Death
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
5
num At Risk
9
num Events
5
term
Relapse of underlying disease
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Congestive heart failure
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
MSOF leading to death
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
3
num At Risk
9
num Events
3
term
Fever of unknown etiology
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
term
Allergic reaction
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Myopathy
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Creatinine Phosphokinase
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Diarrhea
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Infection with grade 3 ANC - blood
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
Infection with grade 3 ANC - lungs
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
term
ARDS

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Preserved source evidence · Not medical advice