NCT00241358 · ADVERSE EVENTS

Adverse events

Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies · Source last updated 2017-06-06

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
Donors AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3	2 / 46	46 / 46	Not reported / Not reported
Recipients Stem Cell Transplantation Day 0	12 / 46	46 / 46	Not reported / Not reported

Group identifiers: EG000: Donors · EG001: Recipients

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
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Ankle pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
C. Difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Congestive heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Death due to disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Dyspnea

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 (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
46
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Anasarca
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
46
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Ankle pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
46
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Arm pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
46
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Bladder spasm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
46
term
Bradycardia

Complete source fields

event Groups

description
AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
id
EG000
other Num Affected
46
other Num At Risk
46
serious Num Affected
2
serious Num At Risk
46
title
Donors
description
Stem Cell Transplantation Day 0
id
EG001
other Num Affected
46
other Num At Risk
46
serious Num Affected
12
serious Num At Risk
46
title
Recipients

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
46
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Anasarca
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
46
group Id
EG001
num Affected
0
num At Risk
46
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Ankle pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
7
num At Risk
46
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Arm pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
46
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Bacteremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Bladder spasm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
46
group Id
EG001
num Affected
4
num At Risk
46
term
Bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Ankle pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
C. Difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Congestive heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
1
num At Risk
46
term
Death due to disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
3
num At Risk
46
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
0
num At Risk
46
group Id
EG001
num Affected
2
num At Risk
46
term
Dyspnea

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Preserved source evidence · Not medical advice