NCT00963872 · ADVERSE EVENTS

Adverse events

Donor Umbilical Cord Blood Transplant After Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Cancer · Source last updated 2017-12-28

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: 100 days after umbilical cord blood transplant
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Complement Fragment 3A - Small Cell Dose Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.	21 / 24	24 / 24	Not reported / Not reported
Complement Fragment A - Larger Cell Dose Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.	5 / 5	5 / 5	Not reported / Not reported

Group identifiers: EG000: Complement Fragment 3A - Small Cell Dose · EG001: Complement Fragment A - Larger Cell Dose

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
10
num At Risk
24
num Events
10
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Blood and lymphatic disorders- Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Stomach pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Upper gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death due to disease
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
5
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Catheter related infection

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
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
24
num Events
3
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
24
num At Risk
24
num Events
24
group Id
EG001
num Affected
4
num At Risk
5
num Events
4
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
24
num Events
4
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Neurologic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
24
num Events
7
group Id
EG001
num Affected
2
num At Risk
5
num Events
2
term
Sinus bradycardia

Complete source fields

event Groups

description
Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
id
EG000
other Num Affected
24
other Num At Risk
24
serious Num Affected
21
serious Num At Risk
24
title
Complement Fragment 3A - Small Cell Dose
description
Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Complement Fragment A - Larger Cell Dose

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
24
num Events
3
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
24
num At Risk
24
num Events
24
group Id
EG001
num Affected
4
num At Risk
5
num Events
4
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
24
num Events
4
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Neurologic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
24
num Events
7
group Id
EG001
num Affected
2
num At Risk
5
num Events
2
term
Sinus bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
10
num At Risk
24
num Events
10
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Blood and lymphatic disorders- Other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Stomach pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Upper gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death due to disease
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
24
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
24
num Events
5
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
24
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
24
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Catheter related infection

time Frame

100 days after umbilical cord blood transplant

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Preserved source evidence · Not medical advice