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NCT01273766 · OUTCOME

Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies · Source last updated 2018-09-07

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline, up to 6 months

What was measured

Records will be assessed at baseline and prospectively while on study.

Analysis population: Number analyzed in rows differs from overall because data was not collected on all participants.

Groups in this outcome

Arm I

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity. deferasirox : Given orally laboratory biomarker analysis : Correlative studies enzyme-linked immunosorbent assay : Correlative studies

Correlative

treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis

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
Arm I	4
Correlative	5

Reported measurements

Baseline : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	2
Correlative	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	2	Not reported	Not reported	Not reported	Not reported
Correlative	5	Not reported	Not reported	Not reported	Not reported

Baseline : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	2
Correlative	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

Baseline : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	2
Correlative	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

Baseline : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	2
Correlative	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	5	Not reported	Not reported	Not reported	Not reported

1 Month : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

1 Month : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

1 Month : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

1 Month : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

2 Month : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

2 Month : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

2 Month : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

2 Month : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

3 Month : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

3 Month : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

3 Month : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

3 Month : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

4 Month : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

4 Month : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

4 Month : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

4 Month : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

5 Month : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	2	Not reported	Not reported	Not reported	Not reported

5 Month : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

5 Month : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

5 Month : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	3
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	1	Not reported	Not reported	Not reported	Not reported

6 Month : Hospitalization

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	3	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

6 Month : Ventilator

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

6 Month : Transfusion

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	0	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

6 Month : Antibiotics

Analysis denominator · Participants

Group	Source count
Arm I	4
Correlative	2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1	Not reported	Not reported	Not reported	Not reported
Correlative	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
5
units
Participants
title
Baseline : Hospitalization
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
5
units
Participants
title
Baseline : Ventilator
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
5
units
Participants
title
Baseline : Transfusion
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
5
units
Participants
title
Baseline : Antibiotics
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
1 Month : Hospitalization
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
1 Month : Ventilator
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
1 Month : Transfusion
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
units
Participants
title
1 Month : Antibiotics
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants
title
2 Month : Hospitalization
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants
title
2 Month : Ventilator
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants
title
2 Month : Transfusion
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants
title
2 Month : Antibiotics

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
5
units
Participants

description

Records will be assessed at baseline and prospectively while on study.

groups

description
Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity. deferasirox : Given orally laboratory biomarker analysis : Correlative studies enzyme-linked immunosorbent assay : Correlative studies
id
OG000
title
Arm I
description
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
id
OG001
title
Correlative

param Type

COUNT_OF_PARTICIPANTS

population Description

Number analyzed in rows differs from overall because data was not collected on all participants.

reporting Status

POSTED

time Frame

Baseline, up to 6 months

title

Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice