NCT00549848 · OUTCOME

Probability of CNS Relapse

Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2022-08-23

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

Measure: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

What was measured

To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse.

Analysis population: Patients with features associated with increased risk for CNS relapse in Total XVI and Total XV.

Groups in this outcome

TOTXVI PEG 3500

Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase

TOTXVI PEG 2500

Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase

TOTXVI Not Randomized

Patients who came off study prior to randomization

All Eligible Patients in TOTXV

Patients with features associated with increased risk for CNS relapse in Total XV

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
TOTXVI PEG 3500	121
TOTXVI PEG 2500	125
TOTXVI Not Randomized	113
All Eligible Patients in TOTXV	248

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
TOTXVI PEG 3500	0.8	Not reported	0.0	2.5	Not reported
TOTXVI PEG 2500	1.8	Not reported	0.0	4.3	Not reported
TOTXVI Not Randomized	2.7	Not reported	0.0	5.7	Not reported
All Eligible Patients in TOTXV	5.7	Not reported	2.8	8.6	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.0
upper Limit
2.5
value
0.8
group Id
OG001
lower Limit
0.0
upper Limit
4.3
value
1.8
group Id
OG002
lower Limit
0.0
upper Limit
5.7
value
2.7
group Id
OG003
lower Limit
2.8
upper Limit
8.6
value
5.7

denoms

counts
group Id
OG000
value
121
group Id
OG001
value
125
group Id
OG002
value
113
group Id
OG003
value
248
units
Participants

description

To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse.

dispersion Type

95% Confidence Interval

groups

description
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
id
OG000
title
TOTXVI PEG 3500
description
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
id
OG001
title
TOTXVI PEG 2500
description
Patients who came off study prior to randomization
id
OG002
title
TOTXVI Not Randomized
description
Patients with features associated with increased risk for CNS relapse in Total XV
id
OG003
title
All Eligible Patients in TOTXV

param Type

NUMBER

population Description

Patients with features associated with increased risk for CNS relapse in Total XVI and Total XV.

reporting Status

POSTED

time Frame

For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

title

Probability of CNS Relapse

type

SECONDARY

unit Of Measure

Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice