NCT00089011 · ADVERSE EVENTS

Adverse events

Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer · 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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies	8 / 100	28 / 100	Not reported / Not reported
Arm II (Nonmyeloablative Conditioning With TBI) Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies	5 / 50	17 / 50	Not reported / Not reported

Group identifiers: EG000: Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI) · EG001: Arm II (Nonmyeloablative Conditioning With TBI)

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
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Death, Renal Failure, Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Death due to severe refractory autoimmune hemolytic anemia (present prior to transplant)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Death, elevated bilirubin, fevers
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Right central artery occlusion with right eye blindness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Severe abdominal pain due to gut GVHD and supravantricular arrhythmia/Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Mental Status Change while on ativan, oxycodone, and flexeril
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Elevated LFT's with rising total bilirubin level
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Hypoxia and Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Death, secondary to sepsis with multiorgan failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Perforated gastric ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Death due to adenovirus nephritis, sepsis, multifactorial renal failure

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
Renal and urinary disorders
stats
group Id
EG000
num Affected
20
num At Risk
100
group Id
EG001
num Affected
15
num At Risk
50
term
Increased Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Hemolysis / Hemolytic Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
8
num At Risk
100
group Id
EG001
num Affected
3
num At Risk
50
term
Hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
group Id
EG001
num Affected
2
num At Risk
50
term
Hypoxia / Hypoxemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
4
num At Risk
50
term
Hypotension

Complete source fields

event Groups

description
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
28
other Num At Risk
100
serious Num Affected
8
serious Num At Risk
100
title
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
description
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
17
other Num At Risk
50
serious Num Affected
5
serious Num At Risk
50
title
Arm II (Nonmyeloablative Conditioning With TBI)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
20
num At Risk
100
group Id
EG001
num Affected
15
num At Risk
50
term
Increased Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Hemolysis / Hemolytic Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
8
num At Risk
100
group Id
EG001
num Affected
3
num At Risk
50
term
Hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
group Id
EG001
num Affected
2
num At Risk
50
term
Hypoxia / Hypoxemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
4
num At Risk
50
term
Hypotension

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Death, Renal Failure, Cardiac Failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Death due to severe refractory autoimmune hemolytic anemia (present prior to transplant)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Death, elevated bilirubin, fevers
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Right central artery occlusion with right eye blindness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Severe abdominal pain due to gut GVHD and supravantricular arrhythmia/Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Mental Status Change while on ativan, oxycodone, and flexeril
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
100
group Id
EG001
num Affected
0
num At Risk
50
term
Elevated LFT's with rising total bilirubin level
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Hypoxia and Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Death, secondary to sepsis with multiorgan failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Perforated gastric ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
100
group Id
EG001
num Affected
1
num At Risk
50
term
Death due to adenovirus nephritis, sepsis, multifactorial renal failure

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Preserved source evidence · Not medical advice