The primary efficacy variable was hematologic response, a composite endpoint defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC).

The analysis was performed in Full analysis set (FAS) population was defined according to the intention-to-treat principle. Population included all participants enrolled into the study. Enrolled participant were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted participant population.

Duration of hematologic response is defined as the time from the first documentation of the hematologic response to the date of the first documentation of the disease progression

The analysis was performed in FAS population was defined according to the intention-to-treat principle. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Because of a lack of evidence of hematologic response (primary objective), secondary efficacy endpoints were not analyzed.

Durations of complete cytogenetic response is defined as the time from the first documentation of the major/complete response to the first documentation of the disease progression.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Because of a lack of evidence of hematologic response (primary objective), secondary efficacy endpoints were not analyzed.

Durations of major/complete cytogenetic response is defined as the time from the first documentation of the major/complete response to the first documentation of the disease progression.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Because of a lack of evidence of hematologic response (primary objective), secondary efficacy endpoints were not analyzed.

Cytogenetic response was assessed by bone marrow assessment based on the percentage of Ph+ metaphases by karyotype analysis on a bone marrow aspirate, was ideally assessed from a minimum of 20 metaphases in each bone marrow sample.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Because of a lack of evidence of hematologic response (primary objective), secondary efficacy endpoints were not analyzed.

The duration of response was defined as the time between the first documented response to the date of discontinuation due to progressive disease (PD) or death.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Because of a lack of evidence of hematologic response (primary objective), secondary efficacy endpoints were not analyzed.

Molecular response was defined as major (≤ 0.1% on the International Scale) and complete [absence of fusion gene of the BCR and ABL genes (BCR-ABL) on an quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay with a sensitivity of at least 4.5 logs below baseline].

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Due to insufficient data, this outcome could not be measured.

A fusion gene of the BCR and ABL genes (BCR-ABL) messenger ribose nucleic acid (mRNA) expression (molecular response) was performed by quantitative polymerase chain reaction (qPCR) and mutational analysis was performed by direct sequencing technology, and both analyses were performed by Genzyme.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled participants were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population.

Progressions free survival is defined as time between Day 1 cycle 1 and time to first documented disease progression or death. Disease progression will be determined as per response criteria.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Due to insufficient data, this outcome could not be measured.

Overall survival time is defined as the time from the treatment start to the date of death due to any reason.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population. Due to insufficient data, this outcome could not be measured.

Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's Pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.

The analysis was performed in Pharmacokinetic analysis set (PAS) population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.

The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.

The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.

The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.

The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

QTc monitoring was performed on specified days (Cycle1: Day1, 5 and 26), as well as a single pre-dose ECG once weekly during Cycle1: Week2 and Week3, Cycle2, and all subsequent cycles. Patient eligibility was ensured by a screening QTcF interval calculated by eResearchTechnology(eRT) prior to the baseline assessments. Treatment decisions were based on QTc determined by the automated reading at the investigational site (commonly used the Bazett's correction,QTcB) or measured and calculated by trained personnel at the site. Dosing relied on the investigator's assessment of the 6 baseline ECGs (the average of the 6pre-dose QTc intervals) performed prior to Cycle1/Day1 dosing, of the 3pre-dose ECGs during Cycle1:Day5 and 26, and of the single pre-dose ECGs performed once weekly for the remaining weeks of Cycle1 and subsequent cycles. The Baseline and Change From Baseline to Extreme Value QTcF interval for analysis was calculated by eRT based on the 6 baseline ECGs obtained on Cycle1/Day1.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study. Enrolled patients were those who had received at least one dose of study drug. The outcome measure was not achieved as the study was terminated because of a lack of evidence of activity in the targeted Participant population.

Adverse Events (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards

The analysis was performed on Safety population consisted of all participants who had received at least one dose of study medication and had one valid post-baseline assessment.