NCT00123474 · OUTCOME

Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML · Source last updated 2016-08-25

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: 6 months, 24 months

What was measured

A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets \< 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); \< 5% myelocytes plus metamyelocytes in PB; Basophils in PB \< 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.

Analysis population: All randomized imatinib-resistant participants with available data were summarized.

Groups in this outcome

Dasatinib 100 mg QD

Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 140 mg QD

Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 50 mg BID

Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 70 mg BID

Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

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
Dasatinib 100 mg QD	124
Dasatinib 140 mg QD	123
Dasatinib 50 mg BID	124
Dasatinib 70 mg BID	127

Reported measurements

6 Months (n=124,123,124,127)

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 100 mg QD	86.3	Not reported	79.0	91.8	Not reported
Dasatinib 140 mg QD	85.4	Not reported	77.9	91.1	Not reported
Dasatinib 50 mg BID	91.1	Not reported	84.7	95.5	Not reported
Dasatinib 70 mg BID	87.4	Not reported	80.3	92.6	Not reported

24 Month (n=124,123,124,126)

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Dasatinib 100 mg QD	88.7	Not reported	81.8	93.7	Not reported
Dasatinib 140 mg QD	86.2	Not reported	78.8	91.7	Not reported
Dasatinib 50 mg BID	91.9	Not reported	85.7	96.1	Not reported
Dasatinib 70 mg BID	88.9	Not reported	82.1	93.8	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
79.0
upper Limit
91.8
value
86.3
group Id
OG001
lower Limit
77.9
upper Limit
91.1
value
85.4
group Id
OG002
lower Limit
84.7
upper Limit
95.5
value
91.1
group Id
OG003
lower Limit
80.3
upper Limit
92.6
value
87.4
title
6 Months (n=124,123,124,127)
categories
measurements
group Id
OG000
lower Limit
81.8
upper Limit
93.7
value
88.7
group Id
OG001
lower Limit
78.8
upper Limit
91.7
value
86.2
group Id
OG002
lower Limit
85.7
upper Limit
96.1
value
91.9
group Id
OG003
lower Limit
82.1
upper Limit
93.8
value
88.9
title
24 Month (n=124,123,124,126)

denoms

counts
group Id
OG000
value
124
group Id
OG001
value
123
group Id
OG002
value
124
group Id
OG003
value
127
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
id
OG000
title
Dasatinib 100 mg QD
description
Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
id
OG001
title
Dasatinib 140 mg QD
description
Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
id
OG002
title
Dasatinib 50 mg BID
description
Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
id
OG003
title
Dasatinib 70 mg BID

param Type

NUMBER

population Description

All randomized imatinib-resistant participants with available data were summarized.

reporting Status

POSTED

time Frame

6 months, 24 months

title

Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice