NCT01028716 · OUTCOME

Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2023-01-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: events
Interval / dispersion: Not reported
Time frame: Up to day 90

What was measured

Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined.

Groups in this outcome

Treatment (Nonmyeloablative HCT, TBI)

Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (Nonmyeloablative HCT, TBI)	45

Reported measurements

Cardiac

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	13	Not reported	Not reported	Not reported	Not reported

Fever

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	9	Not reported	Not reported	Not reported	Not reported

Rash

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	4	Not reported	Not reported	Not reported	Not reported

Gastrointestinal

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	17	Not reported	Not reported	Not reported	Not reported

Infections

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	55	Not reported	Not reported	Not reported	Not reported

CMV Reactivation

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	26	Not reported	Not reported	Not reported	Not reported

Febrile Neutropenia

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	25	Not reported	Not reported	Not reported	Not reported

Metabolic/laboratory

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	24	Not reported	Not reported	Not reported	Not reported

Musculoskeletal

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	3	Not reported	Not reported	Not reported	Not reported

Neurologic

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	5	Not reported	Not reported	Not reported	Not reported

Pain

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	6	Not reported	Not reported	Not reported	Not reported

Pulmonary

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	10	Not reported	Not reported	Not reported	Not reported

Renal/Genitourinary

Values in events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nonmyeloablative HCT, TBI)	10	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
13
title
Cardiac
categories
measurements
group Id
OG000
value
9
title
Fever
categories
measurements
group Id
OG000
value
4
title
Rash
categories
measurements
group Id
OG000
value
17
title
Gastrointestinal
categories
measurements
group Id
OG000
value
55
title
Infections
categories
measurements
group Id
OG000
value
26
title
CMV Reactivation
categories
measurements
group Id
OG000
value
25
title
Febrile Neutropenia
categories
measurements
group Id
OG000
value
24
title
Metabolic/laboratory
categories
measurements
group Id
OG000
value
3
title
Musculoskeletal
categories
measurements
group Id
OG000
value
5
title
Neurologic
categories
measurements
group Id
OG000
value
6
title
Pain
categories
measurements
group Id
OG000
value
10
title
Pulmonary

denoms

counts
group Id
OG000
value
45
units
Participants

description

Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined.

groups

description
Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
id
OG000
title
Treatment (Nonmyeloablative HCT, TBI)

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to day 90

title

Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System

type

SECONDARY

unit Of Measure

events

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

Preserved source evidence · Not medical advice