NCT00036738 · ADVERSE EVENTS

Adverse events

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib · Source last updated 2020-01-29

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: AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Allogeneic Nonmyeloablative HSCT) See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI	2 / 28	8 / 28	Not reported / Not reported

Group identifiers: EG000: Treatment (Allogeneic Nonmyeloablative HSCT)

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
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Intracranial hemorrhage

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
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Transient ischemic attacks

Complete source fields

event Groups

description
See Detailed Description Cyclosporine: Given IV or PO Dasatinib: Given PO Fludarabine Phosphate: Given IV Imatinib Mesylate: Given PO Mycophenolate Mofetil: Given PO Nilotinib: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation Therapeutic Allogeneic Lymphocytes: Given IV Total-Body Irradiation: Undergo TBI
id
EG000
other Num Affected
8
other Num At Risk
28
serious Num Affected
2
serious Num At Risk
28
title
Treatment (Allogeneic Nonmyeloablative HSCT)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Bronchopulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Transient ischemic attacks

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Intracranial hemorrhage

time Frame

AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice