NCT00309842 · ADVERSE EVENTS

Adverse events

Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases · Source last updated 2020-09-10

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: Upto 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Unrelated UCBT for Blood Cancers Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.	92 / 212	187 / 212	161 / 212

Group identifiers: EG000: Unrelated UCBT for Blood Cancers

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
212
num Events
4
term
Acute respiratory distress syndrome (ARDS)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
cardiopulmonary arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
41
num At Risk
212
num Events
41
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
212
num Events
9
term
Graft failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
13
num At Risk
212
num Events
13
term
Graft versus host disease (GVHD)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
10
num At Risk
212
num Events
11
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Progressive disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Pulmonary hemorrage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
212
num Events
3
term
Pulmonary other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
212
num Events
7
term
relapse
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Veno-Occlusive Disease (VOD)

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
12
num At Risk
212
num Events
13
term
Multi organ failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
12
num At Risk
212
num Events
14
term
Hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
13
num At Risk
212
num Events
14
term
Neurotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
16
num At Risk
212
num Events
16
term
Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
18
num At Risk
212
num Events
18
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
18
num At Risk
212
num Events
19
term
GI bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
62
num At Risk
212
num Events
62
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
12
num At Risk
212
num Events
19
term
Veno-Occlusive Disease (VOD)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
22
num At Risk
212
num Events
22
term
Hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
23
num At Risk
212
num Events
23
term
Dialysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
25
num At Risk
212
num Events
25
term
Engraftment syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
26
num At Risk
212
num Events
27
term
Acute respiratory distress syndrome (ARDS)

Complete source fields

event Groups

deaths Num Affected
161
deaths Num At Risk
212
description
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
id
EG000
other Num Affected
187
other Num At Risk
212
serious Num Affected
92
serious Num At Risk
212
title
Unrelated UCBT for Blood Cancers

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
12
num At Risk
212
num Events
13
term
Multi organ failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
12
num At Risk
212
num Events
14
term
Hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
13
num At Risk
212
num Events
14
term
Neurotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
16
num At Risk
212
num Events
16
term
Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
18
num At Risk
212
num Events
18
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
18
num At Risk
212
num Events
19
term
GI bleeding
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
62
num At Risk
212
num Events
62
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
12
num At Risk
212
num Events
19
term
Veno-Occlusive Disease (VOD)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
22
num At Risk
212
num Events
22
term
Hyperglycemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
23
num At Risk
212
num Events
23
term
Dialysis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
25
num At Risk
212
num Events
25
term
Engraftment syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
26
num At Risk
212
num Events
27
term
Acute respiratory distress syndrome (ARDS)

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
4
num At Risk
212
num Events
4
term
Acute respiratory distress syndrome (ARDS)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
cardiopulmonary arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
41
num At Risk
212
num Events
41
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
212
num Events
9
term
Graft failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
13
num At Risk
212
num Events
13
term
Graft versus host disease (GVHD)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
10
num At Risk
212
num Events
11
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Progressive disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Pulmonary hemorrage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
212
num Events
3
term
Pulmonary other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
7
num At Risk
212
num Events
7
term
relapse
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
212
num Events
1
term
Veno-Occlusive Disease (VOD)

time Frame

Upto 2 years

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Preserved source evidence · Not medical advice