NCT00553202 · ADVERSE EVENTS

Adverse events

Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia · Source last updated 2020-04-16

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
Group 1 All patients	7 / 90	32 / 90	Not reported / Not reported

Group identifiers: EG000: Group 1

Serious adverse events

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

notes
Adeers submitted
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Adult respiratory distress syndrome
notes
Adeers submitted
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Alanine aminotransferase increased
notes
Adeers submitted
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Ascites
notes
Adeers submitted
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Atelectasis
notes
Adeers submitted
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Blood bilirubin increased
notes
Adeers submitted
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Creatinine increased
notes
Adeers submitted
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Death NOS
notes
Adeers submitted
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Hepatobiliary disorders - Other, specify
notes
Adeers submitted
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Hypercalcemia
notes
Adeers submitted
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Hypoxia
notes
Adeers submitted
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Immune system disorders - Other, specify
notes
Adeers submitted
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Infections and infestations - Other, specify

Other reported adverse events

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

notes
Adeers not subm
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Abdominal distension
notes
Adeers not subm
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Abdominal pain
notes
Adeers not subm
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
5
num At Risk
90
term
Acute kidney injury
notes
Adeers not subm
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Adult respiratory distress syndrome
notes
Adeers not subm
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Allergic reaction
notes
Adeers not subm
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
90
term
Ascites
notes
Adeers not subm
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Aspartate aminotransferase increased
notes
Adeers not subm
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Bladder spasm
notes
Adeers not subm
organ System
Investigations
stats
group Id
EG000
num Affected
11
num At Risk
90
term
Blood bilirubin increased
notes
Adeers not subm
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Bronchopulmonary hemorrhage
notes
Adeers not subm
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Cardiac disorders - Other, specify
notes
Adeers not subm
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Creatinine increased

Complete source fields

event Groups

description
All patients
id
EG000
other Num Affected
32
other Num At Risk
90
serious Num Affected
7
serious Num At Risk
90
title
Group 1

frequency Threshold

other Events

notes
Adeers not subm
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Abdominal distension
notes
Adeers not subm
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Abdominal pain
notes
Adeers not subm
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
5
num At Risk
90
term
Acute kidney injury
notes
Adeers not subm
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Adult respiratory distress syndrome
notes
Adeers not subm
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Allergic reaction
notes
Adeers not subm
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
90
term
Ascites
notes
Adeers not subm
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Aspartate aminotransferase increased
notes
Adeers not subm
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Bladder spasm
notes
Adeers not subm
organ System
Investigations
stats
group Id
EG000
num Affected
11
num At Risk
90
term
Blood bilirubin increased
notes
Adeers not subm
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Bronchopulmonary hemorrhage
notes
Adeers not subm
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Cardiac disorders - Other, specify
notes
Adeers not subm
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Creatinine increased

serious Events

notes
Adeers submitted
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Adult respiratory distress syndrome
notes
Adeers submitted
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Alanine aminotransferase increased
notes
Adeers submitted
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Ascites
notes
Adeers submitted
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Atelectasis
notes
Adeers submitted
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Blood bilirubin increased
notes
Adeers submitted
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Creatinine increased
notes
Adeers submitted
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Death NOS
notes
Adeers submitted
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Hepatobiliary disorders - Other, specify
notes
Adeers submitted
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Hypercalcemia
notes
Adeers submitted
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Hypoxia
notes
Adeers submitted
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
90
term
Immune system disorders - Other, specify
notes
Adeers submitted
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
90
term
Infections and infestations - Other, specify

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Preserved source evidence · Not medical advice