NCT02566304 · ADVERSE EVENTS

Adverse events

Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2025-04-24

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: Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant
Other-event reporting threshold: 0%

CTCAE

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
RIC HSCT, GVHD Prophylaxis RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. Fludarabine: Given IV Total-Body Irradiation: Undergo TBI T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI Cyclophosphamide: Given IV Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant Tacrolimus: Given PO Mycophenolate mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies	10 / 35	33 / 35	1 / 35

Group identifiers: EG000: RIC HSCT, GVHD Prophylaxis

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
notes
Grade 3 - subject 3
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 33
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 13
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 33
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 25
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 12
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 3
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 22 and subject 28
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
num Events
2
term
Cognitive disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 19
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Deliurm
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 25
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Depressed level of Consciousness
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 7
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Ejection Fraction decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 11 \& 26
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
35
num Events
2
term
Fever

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
notes
Grade 1
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Wound-top of head
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Wound of Groin
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Wound on buttock
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
35
num Events
6
term
Wheezing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
35
num Events
4
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
num Events
2
term
Weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
VRE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
18
num At Risk
35
num Events
31
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1 \& 2
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
35
num Events
3
term
Volume overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Vaginal cysts
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
2
term
UTI-VRE
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
9
num At Risk
35
num Events
13
term
Urine incontinence

Complete source fields

description

CTCAE

event Groups

deaths Num Affected
1
deaths Num At Risk
35
description
RIC: Patients receive fludarabine phosphate IV on days -10 to -8 and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI followed by a DLI on day -6. TRANSPLANT: Patients undergo CD34+ peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus PO beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. Fludarabine: Given IV Total-Body Irradiation: Undergo TBI T Cell-Depleted Donor Lymphocyte Infusion: Undergo DLI Cyclophosphamide: Given IV Peripheral Blood Stem Cell Transplantation: Undergo PBSC transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo PBSC transplant Tacrolimus: Given PO Mycophenolate mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
id
EG000
other Num Affected
33
other Num At Risk
35
serious Num Affected
10
serious Num At Risk
35
title
RIC HSCT, GVHD Prophylaxis

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Wound-top of head
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Wound of Groin
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Wound on buttock
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
35
num Events
6
term
Wheezing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
35
num Events
4
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
num Events
2
term
Weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
VRE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
18
num At Risk
35
num Events
31
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1 \& 2
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
35
num Events
3
term
Volume overload
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Vaginal cysts
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
2
term
UTI-VRE
assessment Type
SYSTEMATIC_ASSESSMENT
notes
grade 1
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
9
num At Risk
35
num Events
13
term
Urine incontinence

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Grade 3 - subject 3
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 33
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 13
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 33
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 25
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 12
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 3
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 22 and subject 28
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
num Events
2
term
Cognitive disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 19
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Deliurm
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 25
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Depressed level of Consciousness
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 7
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
num Events
1
term
Ejection Fraction decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
subject 11 \& 26
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
35
num Events
2
term
Fever

time Frame

Adverse Events monitored/assessed from enrollment until d+100 after transplant. All-Cause Mortality monitored/assessed up to 1 year post transplant

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Preserved source evidence · Not medical advice