CompletedNCT00123474Updated Aug 25, 2016Results posted

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

A Phase 3 interventional study of dasatinib and dasatinib in Myeloid Leukemia, Chronic, Chronic-Phase, sponsored by Bristol-Myers Squibb. Completed at 137 sites in 31 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-25.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 724
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study summary

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Conditions studied

Myeloid Leukemia, Chronic, Chronic-Phase

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Keywords

Chronic Phase Chronic Myelogenous Leukemia

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 724 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

Inclusion Criteria:

Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Men and women, 18 years or older
Adequate hepatic function
Adequate renal function
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion criteria

Exclusion Criteria:

Women who are pregnant or breastfeeding
Subjects who are eligible and willing to undergo transplantation during the screening period
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Medications that increase bleeding risk
Medications that change heart rhythms
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
History of significant bleeding disorder unrelated to CML
Concurrent incurable malignancy other than CML
Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 724 participants (actual)

Study arms

Experimental
1
Drug: dasatinib
Experimental
2
Drug: dasatinib
Experimental
3
Drug: dasatinib
Experimental
4
Drug: dasatinib

Interventions

Drugdasatinib
Tablets, Oral, 50 mg BID, indefinitely, survival study
Also known as: Sprycel, BMS-354825
Drugdasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
Also known as: Sprycel, BMS-354825
Drugdasatinib
Tablets, Oral, 100 mg QD, indefinitely, survival study
Also known as: Sprycel, BMS-354825
Drugdasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Also known as: Sprycel, BMS-354825

What researchers measure

Primary outcomes

Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
Time frame: 6 months

Secondary outcomes

Percent of Participants With MCyR At or Prior to 24 Months Follow-Up
CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
Time frame: 24 months
Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up
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.
Time frame: 6 months, 24 months
Time to MCyR in Participants With MCyR at 6 Months Follow-Up
Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).
Time frame: 6 months
Time to CHR in Participants With CHR at 6 Months Follow-Up
Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).
Time frame: 6 months
Time to MCyR in Participants With MCyR at 24 Months Follow-Up
Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.
Time frame: 24 months
Time to CHR in Participants With CHR At 24 Months Follow-Up
Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.
Time frame: 24 months
Number of Participants With MCyR Whose Disease Progressed by 24 Months
Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to \>20,000/mm\^3 or an increase by \> 50,000/mm\^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.
Time frame: 24 months
Number of Participants With CHR Whose Disease Progressed by 24 Months
Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to \>20,000/mm\^3 or an increase by \> 50,000/mm\^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.
Time frame: 24 months
Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants
BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).
Time frame: Baseline up to 24 months
Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.
Time frame: 24, 36, 48, 60, 72, and 84 months
Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.
Time frame: 24, 36, 48, 60, 72, and 84 months
Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose
CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.
Time frame: 6 months, 24 months
Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up
A 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.
Time frame: 6 months, 24 months
Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up
PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.
Time frame: 24, 36, 48, 60, 72, and 84 months
Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up
Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.
Time frame: 24, 36, 48, 60, 72, and 84 months
Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up
Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. 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.
Time frame: 6 months
Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up
Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. 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. No cytogenic assessments were made after 2 years of follow-up.
Time frame: 24 months
Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants
PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.
Time frame: 24, 36, 48, 60, 72, and 84 months
Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants
Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.
Time frame: 24, 36, 48, 60, 72, and 84 months
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.
Time frame: Baseline to 30 days post last dose, up to 24 months
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.
Time frame: Baseline to 30 days post last dose, up to 7 years (study closure July 2014)

Results

Posted Aug 26, 2015

Participant flow

Study initiated July 2005 and completed July 2014.

Randomized to Treatment

Participant flow — Randomized to Treatment
Milestone	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Started	167	167	168	168
Completed	166	163	166	167
Not completed	1	4	2	1
Withdrew: Randomized, never treated	1	4	2	1

As Treated at Study Closure

Participant flow — As Treated at Study Closure
Milestone	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Started	165	163	167	167
Completed	0	0	0	0
Not completed	165	163	167	167
Withdrew: Not reported when site closed	1	0	1	0
Withdrew: Adverse event	10	4	10	8
Withdrew: Disease progression	35	42	29	27
Withdrew: Investigator request	12	6	7	5
Withdrew: Non-specified	54	47	57	60
Withdrew: Study drug toxicity	39	45	45	51
Withdrew: Withdrawal by subject	14	19	18	16

Outcome measures

PrimaryPercent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up

Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.

Time frame:: 6 months
Reported as:: Number · percentage of Participants

Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
percentage of Participants	QD Dasatinib	BID Dasatinib
Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up	51.8 (45.4 to 58.2)	49.0 (42.7 to 55.4)

Statistical analysis

QD Dasatinib vs BID Dasatinib · Risk difference (rd): 2.8 · 95% CI -6.0 to 11.6

SecondaryPercent of Participants With MCyR At or Prior to 24 Months Follow-Up

CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.

Time frame:: 24 months
Reported as:: Number · percentage of Participants

Percent of Participants With MCyR At or Prior to 24 Months Follow-Up
percentage of Participants	Dasatinib QD	Dasatinib BID	Dasatinib 100 mg Total Daily Dose	Dasatinib 140 mg Total Daily Dose
Percent of Participants With MCyR At or Prior to 24 Months Follow-Up	58.3 (51.9 to 64.5)	56.4 (50.0 to 62.6)	57.3 (50.8 to 63.5)	57.4 (51.0 to 63.7)

Statistical analysis

Dasatinib QD vs Dasatinib BID · Risk difference (rd): 1.9 · 95% CI -6.8 to 10.6
Dasatinib 100 mg Total Daily Dose vs Dasatinib 140 mg Total Daily Dose · Risk difference (rd): -0.2 · 95% CI -8.9 to 8.5

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

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.

Time frame:: 6 months, 24 months
Reported as:: Number · percentage of participants

Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up
percentage of participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
6 Months (n=124,123,124,127)	86.3 (79.0 to 91.8)	85.4 (77.9 to 91.1)	91.1 (84.7 to 95.5)	87.4 (80.3 to 92.6)
24 Month (n=124,123,124,126)	88.7 (81.8 to 93.7)	86.2 (78.8 to 91.7)	91.9 (85.7 to 96.1)	88.9 (82.1 to 93.8)

SecondaryTime to MCyR in Participants With MCyR at 6 Months Follow-Up

Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).

Time frame:: 6 months
Reported as:: Median · Months

Time to MCyR in Participants With MCyR at 6 Months Follow-Up
Months	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Time to MCyR in Participants With MCyR at 6 Months Follow-Up	2.8 (2.8 to 3.0)	2.8 (2.8 to 2.9)	2.8 (2.8 to 2.9)	2.8 (2.8 to 3.0)

SecondaryTime to CHR in Participants With CHR at 6 Months Follow-Up

Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).

Time frame:: 6 months
Reported as:: Median · Months

Time to CHR in Participants With CHR at 6 Months Follow-Up
Months	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Time to CHR in Participants With CHR at 6 Months Follow-Up	0.5 (0.5 to 0.6)	0.5 (0.5 to 0.7)	0.6 (0.6 to 0.9)	0.7 (0.5 to 0.9)

SecondaryTime to MCyR in Participants With MCyR at 24 Months Follow-Up

Time frame:: 24 months
Reported as:: Median · Months

Time to MCyR in Participants With MCyR at 24 Months Follow-Up
Months	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Time to MCyR in Participants With MCyR at 24 Months Follow-Up	2.9 (2.8 to 3.4)	2.8 (2.8 to 3.0)	2.9 (2.8 to 3.3)	2.9 (2.8 to 3.0)

SecondaryTime to CHR in Participants With CHR At 24 Months Follow-Up

Time frame:: 24 months
Reported as:: Median · Months

Time to CHR in Participants With CHR At 24 Months Follow-Up
Months	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Time to CHR in Participants With CHR At 24 Months Follow-Up	0.5 (0.5 to 0.6)	0.5 (0.5 to 0.7)	0.6 (0.5 to 0.9)	0.7 (0.5 to 0.9)

SecondaryNumber of Participants With MCyR Whose Disease Progressed by 24 Months

Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to \>20,000/mm\^3 or an increase by \> 50,000/mm\^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.

Time frame:: 24 months
Reported as:: Number · participants

Number of Participants With MCyR Whose Disease Progressed by 24 Months
participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Number of Participants With MCyR Whose Disease Progressed by 24 Months	5	17	6	9

SecondaryNumber of Participants With CHR Whose Disease Progressed by 24 Months

Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to \>20,000/mm\^3 or an increase by \> 50,000/mm\^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.

Time frame:: 24 months
Reported as:: Number · participants

Number of Participants With CHR Whose Disease Progressed by 24 Months
participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Number of Participants With CHR Whose Disease Progressed by 24 Months	18	28	22	24

SecondaryNumber of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants

BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).

Time frame:: Baseline up to 24 months
Reported as:: Number · participants

Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants
participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Imatinib-resistant Mutations	49	49	62	48
Mutations with unknown Imatinib-resistance status	0	1	1	2
Imatinib Resistant or unknown mutations	49	50	63	50
Polymorphisms	0	2	0	0
No Mutations	98	87	86	96

SecondaryPercent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up

PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.

Time frame:: 24, 36, 48, 60, 72, and 84 months
Reported as:: Number · percentage of participants

Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
percentage of participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
24 Months (n=124,123,124, 127)	75.2 (66.3 to 82.1)	61.3 (52.7 to 69.6)	70.3 (60.8 to 77.9)	70.8 (61.6 to 78.2)
36 Months (n=124,123,124, 127)	64.8 (55.2 to 72.9)	47.4 (37.7 to 56.5)	67.1 (57.3 to 75.1)	58.2 (48.4 to 66.8)
48 Months (n=124,123,124, 127)	57.8 (48.0 to 66.5)	40.0 (30.6 to 49.3)	63.8 (53.7 to 72.2)	55.1 (45.2 to 64.8)
60 Months (n=124,123,124, 127)	50.2 (40.2 to 59.3)	36.4 (27.1 to 45.8)	57.4 (46.9 to 66.5)	50.2 (40.2 to 59.4)
72 Months (n=124,123,124, 127)	44.0 (34.0 to 53.6)	31.4 (22.4 to 40.8)	50.7 (40.0 to 60.4)	45.3 (35.2 to 54.8)
84 Months (n=124,123,124, 127)	39.0 (29.2 to 48.7)	30.2 (21.2 to 39.6)	42.1 (31.5 to 52.4)	41.3 (31.3 to 51.0)

SecondaryPercent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up

Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.

Time frame:: 24, 36, 48, 60, 72, and 84 months
Reported as:: Number · percentage of participants

Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
percentage of participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
24 Months (n=124,123,124,127)	90.1 (83.2 to 94.2)	93.9 (87.6 to 97.0)	88.9 (81.6 to 93.4)	85.1 (77.3 to 90.3)
36 Months (n=124,123,124,127)	87.5 (80.2 to 92.3)	83.8 (75.6 to 89.5)	83.5 (75.3 to 89.1)	76.5 (67.7 to 83.1)
48 Months (n=124,123,124,127)	79.7 (71.3 to 85.9)	82.0 (73.4 to 88.0)	80.7 (72.1 to 86.9)	71.1 (61.9 to 78.4)
60 Months (n=124,123,124,127)	75.1 (66.1 to 82.0)	78.0 (68.9 to 84.7)	73.6 (64.1 to 80.9)	69.1 (59.8 to 76.7)
72 Months (n=124,123,124,127)	67.9 (58.3 to 75.8)	72.6 (62.9 to 80.1)	71.4 (61.8 to 79.0)	67.1 (57.6 to 74.9)
84 Months (n=124,123,124,127)	62.6 (52.6 to 71.0)	68.1 (58.0 to 76.2)	67.9 (57.9 to 76.0)	65.0 (55.3 to 73.0)

SecondaryPercent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose

CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.

Time frame:: 6 months, 24 months
Reported as:: Number · percentage of participants

Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose
percentage of participants	QD Dasatinib	BID Dasatinib	Total Daily Dose 100 mg	Total Daily Dose 140 mg
6 Month	72.4 (61.8 to 81.5)	70.6 (59.7 to 80.0)	73.6 (63.0 to 82.4)	69.4 (58.5 to 79.0)
24 Month	77.0 (66.8 to 85.4)	75.6 (65.1 to 84.2)	77.0 (66.8 to 85.4)	75.6 (65.1 to 84.2)

Statistical analysis

QD Dasatinib vs BID Dasatinib · Risk difference (rd): 1.8 · 95% CI -11.7 to 15.3
Total Daily Dose 100 mg vs Total Daily Dose 140 mg · Risk difference (rd): 4.2 · 95% CI -9.3 to 17.6
QD Dasatinib vs BID Dasatinib · Risk difference (rd): 1.4 · 95% CI -11.2 to 14.1
Total Daily Dose 100 mg vs Total Daily Dose 140 mg · Risk difference (rd): 1.4 · 95% CI -11.2 to 14.1

SecondaryPercent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up

A 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.

Time frame:: 6 months, 24 months
Reported as:: Number · percentage of participants

Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up
percentage of participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
6 Months (n=43,44,44,41)	100	86	93	85
24 Months (n=43,44,44,42)	100	89	93	86

SecondaryPercent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up

Time frame:: 24, 36, 48, 60, 72, and 84 months
Reported as:: Number · percentage of participants

Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up
percentage of participants	100mg QD	140mg QD	50mg BID	70mg BID
24 Months (n=43,44,44,42)	83.6 (67.0 to 92.3)	87.7 (72.8 to 94.7)	77.4 (61.0 to 87.6)	83.7 (67.1 to 92.4)
36 Months (n=43,44,44,42)	71.7 (53.6 to 83.7)	76.0 (58.7 to 86.8)	68.6 (51.1 to 80.9)	77.4 (59.6 to 88.1)
48 Months (n=43,44,44,42)	62.7 (44.5 to 76.5)	76.0 (58.7 to 86.8)	62.0 (44.1 to 75.7)	66.9 (47.8 to 80.4)
60 Months (n=43,44,44,42)	59.2 (40.8 to 73.6)	71.2 (52.1 to 83.8)	62.0 (44.1 to 75.7)	59.5 (40.1 to 74.4)
72 Months (n=43,44,44,42)	59.2 (40.8 to 73.6)	66.5 (46.3 to 80.6)	58.2 (39.8 to 72.7)	55.2 (35.7 to 71.1)
84 Months (n=43,44,44,42)	50.9 (32.1 to 67.0)	66.5 (46.3 to 80.6)	47.5 (27.4 to 65.2)	50.2 (30.4 to 67.1)

SecondaryPercent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up

Time frame:: 24, 36, 48, 60, 72, and 84 months
Reported as:: Number · percentage of participants

Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up
percentage of participants	100mg QD	140mg QD	50mg BID	70mg BID
24 Months (n=43,44,44,42)	94.9 (81.2 to 98.7)	92.8 (79.2 to 97.6)	95.3 (82.5 to 98.8)	97.4 (82.8 to 99.6)
36 Months (n=43,44,44,42)	89.7 (74.9 to 96.0)	92.8 (79.2 to 97.6)	90.4 (76.4 to 96.3)	94.7 (80.6 to 98.7)
48 Months (n=43,44,44,42)	84.5 (68.6 to 92.7)	87.5 (72.4 to 94.6)	85.1 (69.7 to 93.0)	86.8 (71.2 to 94.3)
60 Months (n=43,44,44,42)	81.8 (65.6 to 90.9)	87.5 (72.4 to 94.6)	82.4 (66.6 to 91.2)	81.1 (64.3 to 90.5)
72 Months (n=43,44,44,42)	79.0 (62.3 to 88.9)	87.5 (72.4 to 94.6)	79.6 (63.2 to 89.3)	81.1 (64.3 to 90.5)
84 Months (n=43,44,44,42)	70.0 (52.2 to 82.2)	87.5 (72.4 to 94.6)	76.6 (59.7 to 87.2)	77.7 (60.1 to 88.2)

SecondaryPercent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up

Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. 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.

Time frame:: 6 months
Reported as:: Number · percentage of participants

Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up
percentage of participants	QD Dasatinib	BID Dasatinib	Total Daily Dose 100 mg	Total Daily Dose 140 mg
MCyR (n=334,336,335,335)	57.2 (51.7 to 62.6)	54.5 (49.0 to 59.9)	56.1 (50.6 to 61.5)	55.5 (50.0 to 60.9)
CHR(n=334,336,335,335)	87.7 (83.7 to 91.0)	89.3 (85.5 to 92.4)	90.7 (87.1 to 93.6)	86.3 (82.1 to 89.8)

SecondaryPercent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up

Time frame:: 24 months
Reported as:: Number · percentage of participants

Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up
percentage of participants	QD Dasatinib	BID Dasatinib	Total Daily Dose 100 mg	Total Daily Dose 140 mg
MCyR(n=334,336,335,335)	63.2 (57.8 to 68.4)	61.3 (55.9 to 66.5)	62.4 (57.0 to 67.6)	62.1 (56.7 to 67.3)
CHR (n=334,336,335,335)	89.2 (85.4 to 92.3)	90.2 (86.5 to 93.1)	91.9 (88.5 to 94.6)	87.5 (83.4 to 90.8)

SecondaryPercent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants

Time frame:: 24, 36, 48, 60, 72, and 84 months
Reported as:: Number · percentage of participants

Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants
percentage of participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
24 Months (n=167, 167, 168, 168)	77.4 (69.9 to 83.2)	67.7 (59.6 to 74.5)	72.2 (64.3 to 78.7)	73.9 (66.1 to 80.1)
36 Months (n=167, 167, 168, 168)	66.6 (58.3 to 73.6)	54.0 (45.4 to 61.8)	67.5 (59.2 to 74.5)	62.8 (54.3 to 70.1)
48 Months (n=167, 167, 168, 168)	59.1 (50.6 to 66.6)	48.0 (39.4 to 56.2)	63.3 (54.8 to 70.7)	58.7 (50.1 to 66.3)
60 Months (n=167, 167, 168, 168)	52.5 (43.8 to 60.5)	44.2 (35.5 to 52.5)	58.7 (49.8 to 66.5)	52.5 (43.7 to 60.5)
72 Months (n=167, 167, 168, 168)	40.0 (39.2 to 56.2)	39.2 (30.6 to 47.7)	52.8 (43.7 to 61.1)	47.7 (38.7 to 56.0)
84 Months (n=167, 167, 168, 168)	42.1 (33.4 to 50.6)	38.2 (29.6 to 46.7)	43.9 (34.5 to 52.9)	43.5 (34.5 to 52.1)

SecondaryPercent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants

Time frame:: 24, 36, 48, 60, 72, and 84 months
Reported as:: Number · percentage of participants

Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants
percentage of participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
24 Months (n=167, 167, 168, 168)	91.3 (85.8 to 94.8)	93.6 (88.4 to 96.5)	90.6 (84.9 to 94.2)	88.1 (81.9 to 92.2)
36 Months (n=167, 167, 168, 168)	88.1 (82.0 to 92.3)	86.2 (79.6 to 90.8)	85.3 (78.7 to 90.0)	80.9 (73.9 to 86.3)
48 Months (n=167, 167, 168, 168)	81.0 (73.9 to 86.3)	83.4 (76.4 to 88.5)	81.8 (74.7 to 87.1)	74.9 (67.3 to 81.0)
60 Months (n=167, 167, 168, 168)	76.8 (69.4 to 82.7)	80.5 (73.1 to 86.0)	75.9 (68.2 to 82.0)	72.0 (64.1 to 78.4)
72 Months (n=167, 167, 168, 168)	70.9 (62.9 to 77.5)	76.6 (68.7 to 82.7)	73.6 (65.6 to 80.0)	70.5 (62.5 to 77.1)
84 Months (n=167, 167, 168, 168)	64.6 (56.1 to 71.8)	73.4 (65.2 to 79.9)	70.3 (62.0 to 77.1)	68.1 (59.8 to 74.9)

SecondaryNumber of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up

Time frame:: Baseline to 30 days post last dose, up to 24 months
Reported as:: Number · participants

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up
participants	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID
Any SAE	58	67	73	78
Drug-Related SAE	32	40	47	55
Drug-Related AEs that led to discontinuationt	14	24	20	25
Death within 30 days of last dose	3	2	6	5

SecondaryNumber of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.

Time frame:: Baseline to 30 days post last dose, up to 7 years (study closure July 2014)
Reported as:: Number · participants

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up
participants	100 mg QD	Other Treatment Groups	Total
All Deaths	51	133	184
Deaths on-study or within 30 days post dose	11	15	26
SAEs	75	259	334
AEs Leading to Discontinuation of Treatment	43	153	196

Adverse events

Collected over Baseline to 30 days post last dose, up to 7 years (study closure July 2014). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
100mg QD	—	75/165 (45.5%)	160/165 (97%)
140mg QD	—	78/163 (47.9%)	155/163 (95.1%)
50mg BID	—	89/167 (53.3%)	160/167 (95.8%)
70mg BID	—	92/167 (55.1%)	165/167 (98.8%)

Most frequent serious events

Showing 10 of 285

Most frequent serious events
Event	100mg QD	140mg QD	50mg BID	70mg BID
Pleural effusionRespiratory, thoracic and mediastinal disorders	16/165	27/163	18/167	25/167
PneumoniaInfections and infestations	4/165	15/163	10/167	8/167
DiarrhoeaGastrointestinal disorders	5/165	12/163	5/167	4/167
PyrexiaGeneral disorders	3/165	11/163	6/167	9/167
DyspnoeaRespiratory, thoracic and mediastinal disorders	5/165	7/163	8/167	10/167
ThrombocytopeniaBlood and lymphatic system disorders	2/165	4/163	6/167	9/167
Febrile neutropeniaBlood and lymphatic system disorders	2/165	2/163	3/167	6/167
VomitingGastrointestinal disorders	2/165	5/163	6/167	1/167
InfectionInfections and infestations	5/165	0/163	2/167	2/167
CellulitisInfections and infestations	5/165	2/163	0/167	4/167

Most frequent other events

Showing 10 of 73

Most frequent other events
Event	100mg QD	140mg QD	50mg BID	70mg BID
DiarrhoeaGastrointestinal disorders	67/165	70/163	73/167	82/167
HeadacheNervous system disorders	75/165	73/163	60/167	76/167
NauseaGastrointestinal disorders	37/165	54/163	52/167	69/167
FatigueGeneral disorders	62/165	62/163	56/167	49/167
CoughRespiratory, thoracic and mediastinal disorders	53/165	42/163	57/167	54/167
Pleural effusionRespiratory, thoracic and mediastinal disorders	41/165	51/163	54/167	51/167
RashSkin and subcutaneous tissue disorders	37/165	52/163	43/167	43/167
DyspnoeaRespiratory, thoracic and mediastinal disorders	49/165	51/163	53/167	43/167
VomitingGastrointestinal disorders	23/165	29/163	32/167	52/167
ArthralgiaMusculoskeletal and connective tissue disorders	47/165	39/163	36/167	30/167

Baseline characteristics

All participants randomized to a treatment arm are summarized.

Age, Customized
Age, Customized(participants)	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID	Total
Less than, equal to (<=) 65 years	121	128	130	125	504
Greater than (>) 65 years	46	39	38	43	166

Sex: Female, Male
Sex: Female, Male(Participants)	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID	Total
Female	83	97	83	91	354
Male	84	70	85	77	316

Imatinib Status
Imatinib Status(participants)	Dasatinib 100 mg QD	Dasatinib 140 mg QD	Dasatinib 50 mg BID	Dasatinib 70 mg BID	Total
Primary Resistance to Imatinib	75	78	88	81	322
Acquired Resistance to Imatinib	49	45	36	45	175
Intolerant to Imatinib	43	44	44	42	173

Study locations

137 sites

University Of Alabama At Birmingham
Birmingham, Alabama 35294, United States
Central Hematology Oncology Medical Group Inc.
Alhambra, California 91801, United States
Pacific Cancer Medical Center Inc
Anaheim, California 92801, United States
Loma Linda University Cancer Center
Loma Linda, California 92354, United States
Pacific Shores Medical Group
Long Beach, California 90813, United States
Ucla Dept. Of Medicine
Los Angeles, California 90095, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California 93030, United States
Kaiser Permanente Medical Center
Vallejo, California 94589, United States
Georgetown University Med Ctr
Washington, District of Columbia 20007, United States
Washington Cancer Institute At Washington Hospital Center
Washington, District of Columbia 20010, United States
University Of Florida
Gainesville, Florida 32610, United States
University Of Miami
Miami, Florida 33136, United States
Md Anderson Cancer Center Orlando
Orlando, Florida 32806, United States
Emory University School Of Medicine
Atlanta, Georgia 30322, United States
Georgia Cancer Specialists
Atlanta, Georgia 30341, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia 30046, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois 60611, United States
University Of Chicago
Chicago, Illinois 60637, United States
Oncology Hematology Associates Of Central Illinois, Pc
Peoria, Illinois 61615, United States
Indiana University Cancer Center
Indianapolis, Indiana 46202, United States
University Of Kansas Medical Center
Westwood, Kansas 66205, United States
University Of Kentucky
Lexington, Kentucky 40536, United States
University Of Maryland
Baltimore, Maryland 21201, United States
Dana Faber Cancer Institute
Boston, Massachusetts 02215, United States
Karmanos Cancer Institute
Detroit, Michigan 48201, United States
Washington University School Of Medicine
Saint Louis, Missouri 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska 68114, United States
Devetten, Marcel
Omaha, Nebraska 68198, United States
Nevada Cancer Institute
Las Vegas, Nevada 89135, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey 07601, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey 08903, United States
New York Presbyterian Hospital
New York, New York 10021, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195, United States
Oregon Health & Science University
Portland, Oregon 97239, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania 15224, United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203, United States
Ut Southwestern Medical Center
Dallas, Texas 75390, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington 98109, United States
Local Institution
La Plata, Buenos Aires 1900, Argentina
Local Institution
Buenos Aires, 1221, Argentina
Local Institution
Capital Federal, 1280, Argentina
Local Institution
Cordoba, X5016KEH, Argentina
Local Institution
Camperdown, New South Wales 2050, Australia
Local Institution
St Leonards, New South Wales 2065, Australia
Local Institution
South Brisbane, Queensland 4101, Australia
Local Institution
Adelaide, South Australia SA 5000, Australia
Local Institution
East Melbourne, Victoria 3002, Australia
Local Institution
Perth, Western Australia WA 6000, Australia
Local Institution
Wien, 1090, Austria
Local Institution
B-leuven, 3000, Belgium
Local Institution
Brugge, 8000, Belgium
Local Institution
Bruxelles, 1000, Belgium
Local Institution
Charleroi, 6000, Belgium
Local Institution
Edegem, 2650, Belgium
Local Institution
Yvoir, 5530, Belgium
Local Institution
Curitiba, Parana 80060, Brazil
Local Institution
CEP - Campinas, 13083, Brazil
Local Institution
Rio de Janeiro, 20231, Brazil
Local Institution
San Paulo, Sp, 05403, Brazil
Local Institution
Sao Paulo, 05652, Brazil
Local Institution
Edmonton, Alberta T6G 1Z2, Canada
Local Institution
Hamilton, Ontario L8N 3Z5, Canada
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Montreal, Quebec H2W 1S6, Canada
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Brno, 625 00, Czech Republic
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Prague 2, 128 20, Czech Republic
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Aarhus C, 8000, Denmark
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Herlev, 2730, Denmark
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Odense C, 5000, Denmark
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Helsinki, 00029, Finland
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Cedex, Pierre Benite 69495, France
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Caen, 14000, France
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Creteil Cedex, 94010, France
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Grenoble Cedex 09, 38043, France
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Lille Cedex, 59037, France
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Marseille Cedex 9, 13273, France
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Nantes, 44000, France
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Paris Cedex 10, 75475, France
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Poitiers Cedex, 86021, France
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Strasbourg, 67091, France
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Toulouse Cedex 9, 31059, France
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Dresden, 01307, Germany
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Frankfurt/main, 60590, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Budapest, 1135, Hungary
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Co Galway, Galway, Ireland
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Dublin, 8, Ireland
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Ramat-gan, 52621, Israel
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Bari, 70124, Italy
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Monza (mi), 20052, Italy
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Napoli, 80131, Italy
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Orbassano, 10043, Italy
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Roma, 00144, Italy
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Roma, 00161, Italy
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Jeollanam-do, 519-809, Korea, Republic of
Local Institution
Kyunggi-do, 480-130, Korea, Republic of

Showing the first 100 of 137 sites across 31 countries.

References and documents

Publications

Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86. doi: 10.1002/cncr.24734. PubMed 19924787 ↗
Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24. PubMed 19779040 ↗
Shah NP, Kantarjian HM, Kim DW, Rea D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9. PubMed 18541900 ↗
Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423. Epub 2016 Jun 20. PubMed 27192969 ↗
Shah NP, Guilhot F, Cortes JE, Schiffer CA, le Coutre P, Brummendorf TH, Kantarjian HM, Hochhaus A, Rousselot P, Mohamed H, Healey D, Cunningham M, Saglio G. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014 Apr 10;123(15):2317-24. doi: 10.1182/blood-2013-10-532341. Epub 2014 Feb 25. PubMed 24569263 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00123474
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jul 25, 2005
Start date: Jul 2005
Primary completion: Sep 2006
Completion: Jul 2014
Results posted: Aug 26, 2015
Last update: Aug 25, 2016

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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