Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

• ClinicalTrials.gov Identifier: NCT03128411
• Recruitment Status: Completed
• First Posted: April 25, 2017
• Results First Posted: November 24, 2020
• Last Update Posted: May 19, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leukemia, Chronic Myelogenous
• Intervention: Drug: Bosutinib
• Enrollment: 64

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Bosutinib
Arm/Group Description	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Period Title: Treatment Phase
Started	60
Received Treatment	60
Completed	36
Not Completed	24
Reason Not Completed
Adverse Event	21
Physician Decision	1
Other	2
Period Title: Long Term Follow-up Phase
Started	24 [1]
Completed	22
Not Completed	2
Reason Not Completed
Death	2
[1] Participants who discontinued treatment phase, entered in long term follow up phase.

Baseline Characteristics

Arm/Group Title		Bosutinib
Arm/Group Description		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Baseline Participants		60
Baseline Analysis Population Description		As-treated population included all enrolled participants who received at least 1 dose of study treatment.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	60 participants
		53.3 (16.40)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	60 participants
	Female	24 40.0%
	Male	36 60.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	60 participants
	Hispanic or Latino	0 0.0%
	Not Hispanic or Latino	60 100.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	60 participants
	American Indian or Alaska Native	0 0.0%
	Asian	60 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	0 0.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Major Molecular Response (MMR) at Month 12
Description	A MMR is defined as less than or equal to (<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a >=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the 12-month visit; any MMR gained and lost, or never achieved at or before the 12-month visit was considered as non-responder.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	55.0; (44.4 to 65.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bosutinib
	Comments	With a sample size of 60 participants, study was powered at >82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	z-test, 1-sided
	Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants With Major Molecular Response (MMR) by Month 12
Description	A MMR is defined as less than or equal to (<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a >=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at or before the 12-month visit.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	61.7; (51.3 to 72.0)

3. Secondary Outcome

Title	Percentage of Participants With Major Molecular Response (MMR) by Month 18
Description	A MMR is defined as less than or equal to (<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a >=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at or before the 18-month visit.
Time Frame	Up to Month 18

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	66.7; (56.7 to 76.7)

4. Secondary Outcome

Title	Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12
Description	CCyR is based on the prevalence of Philadelphia chromosome positive metaphases among cells in metaphase on a bone marrow sample. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed. The CCyR value was counted only if the response was demonstrated at or before the 12-month visit.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	80.0; (71.5 to 88.5)

5. Secondary Outcome

Title	Probability of Maintaining Major Molecular Response (MMR) at Month 36
Description	Duration of MMR: time from first date of MMR until first date of confirmed loss of MMR, treatment discontinuation due to progressive disease (PD), or death due to PD within 28 days after last dose or censoring. PD: progression to Accelerated phase (AP) or to Blast Phase (BP). AP: 15-29% blasts in blood or marrow, or>30% blasts plus promyelocytes in blood or marrow with blasts <30%; ≥20% basophils in blood. BP: ≥30% Blasts in blood or bone marrow, extramedullary blast proliferation, other than in spleen. Kaplan-Meier analysis was used.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had MMR.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	42
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	100.0; (100.0 to 100.0)

6. Secondary Outcome

Title	Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36
Description	Duration of CCyR, from first date of CCyR to confirmed loss of CCyR, treatment discontinuation due to PD, death due to PD within 28 days after last dose or censoring. Confirmed loss: at least 1 Ph+ metaphase confirmed by a second determination >=4 weeks later or unconfirmed loss followed by treatment discontinuation due to suboptimal response. PD: progression to AP or to BP. Kaplan-Meier analysis was used.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure and who had CCyR.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	48
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	100.0; (100.0 to 100.0)

7. Secondary Outcome

Title	Cumulative Incidence of Event Free Survival (EFS) at Month 36
Description	EFS: time from 1st dose until 1st occurrence of 1 of the following events or censoring: 1)death from any cause 2)transformation to AP or BP 3)loss of complete hematologic response (CHR) 4)loss of CCyR 5)participants not achieving CHR: doubling of WBCs >= 1 month apart with 2nd value >20*10^9/L and maintained in subsequent assessments for >=2 weeks. Loss of CHR: appearance of any of the following confirmed by 2nd determination>=4 weeks later (unless associated with CML-related treatment discontinuation): WBC count: >20.0*10^9/L, platelet count: >=600*10^9/L, appearance of palpable spleen/other extra medullary involvement, appearance of 5% myelocytes or blasts or promyelocytes in peripheral blood. Loss of CCyR:>= one Ph+ metaphase confirmed by 2nd determination >=4 weeks later(unless associated with CML-related treatment discontinuation). Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without event.
Time Frame	Up to Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	1.7; (0.2 to 6.4)

8. Secondary Outcome

Title	Probability of Overall Survival (OS) at Month 36
Description	Overall survival was defined as the time from first dose of study drug to death due to any cause or censoring. Kaplan-Meier analysis was used for determination of probability of overall survival.
Time Frame	Up to Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	96.7; (89.7 to 98.9)

9. Secondary Outcome

Title	Trough Plasma Concentrations of Bosutinib
Description	[Not Specified]
Time Frame	Pre-dose on Day 1, Day 28, Day 56, Day 84

Outcome Measure Data

Analysis Population Description

The PK population will be defined as any patient in the safety population of patients who had at least 1 concentration of bosutinib on-treatment.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: Nanogram per milliliter (ng/mL)
Day 1	Number Analyzed	60 participants
		0.000 (0.000)
Day 28	Number Analyzed	34 participants
		83.564 (64.1056)
Day 56	Number Analyzed	41 participants
		85.963 (46.4095)
Day 84	Number Analyzed	44 participants
		79.659 (41.5369)

10. Secondary Outcome

Title	Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response
Description	Trough bosutinib plasma concentration is reported classified on basis of participants with MMR response as "Yes" and "No" at specified time points. A MMR is defined as less than or equal to (<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a >=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Yes: Day 28	Number Analyzed	23 participants
		94.943 (71.9332)
No: Day 28	Number Analyzed	11 participants
		59.770 (35.4568)
Yes: Day 56	Number Analyzed	26 participants
		88.196 (48.9671)
No: Day 56	Number Analyzed	15 participants
		82.092 (42.9741)
Yes: Day 84	Number Analyzed	31 participants
		81.339 (41.5443)
No: Day 84	Number Analyzed	13 participants
		75.654 (42.9290)

11. Secondary Outcome

Title	Summary and Analysis of Trough Bosutinib Plasma Concentration by CCyR Response
Description	Trough bosutinib plasma concentration is reported classified on basis of participants with CCyR Response as "Yes" and "No" at specified time points. CCyR is based on the prevalence of Philadelphia chromosome positive metaphases among cells in metaphase on a bone marrow sample. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Yes: Day 28	Number Analyzed	32 participants
		87.006 (64.1820)
No: Day 28	Number Analyzed	2 participants
		28.490 (38.3393)
Yes: Day 56	Number Analyzed	36 participants
		90.550 (45.4543)
No: Day 56	Number Analyzed	5 participants
		52.936 (43.6721)
Yes: Day 84	Number Analyzed	41 participants
		79.429 (40.1538)
No: Day 84	Number Analyzed	3 participants
		82.800 (69.5117)

12. Secondary Outcome

Title	Summary of Trough Bosutinib Plasma Concentration by Total Bilirubin
Description	Trough bosutinib plasma concentration is reported classified on basis of total bilirubin level range at baseline. Level range 1: <=7.7 micromole per liter (micromol/L), level rage 2: >7.7 and <= 10.3 micromol/L, level range 3: >10.3 and <=12.85 micromol/L and level range 4: >12.85 micromol/L.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against each categories/levels respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Day 28: (<=7.7 micromol/L)	Number Analyzed	6 participants
		61.833 (18.0632)
Day 28: (>7.7 and <=10.3 micromol/L)	Number Analyzed	12 participants
		96.867 (87.7756)
Day 28: (>10.3 and <=12.85 micromol/L)	Number Analyzed	6 participants
		76.963 (59.0962)
Day 28: (>12.85 micromol/L)	Number Analyzed	10 participants
		84.599 (54.3057)
Day 56: (<=7.7 micromol/L)	Number Analyzed	9 participants
		60.044 (22.6753)
Day 56: (>7.7 and <=10.3 micromol/L)	Number Analyzed	13 participants
		81.246 (44.3985)
Day 56: (>10.3 and <=12.85 micromol/L)	Number Analyzed	7 participants
		91.940 (49.9495)
Day 56: (>12.85 micromol/L)	Number Analyzed	12 participants
		107.025 (53.5192)
Day 84: (<=7.7 micromol/L)	Number Analyzed	8 participants
		50.775 (19.4910)
Day 84: (>7.7 and <=10.3 micromol/L)	Number Analyzed	18 participants
		75.478 (34.0806)
Day 84: (>10.3 and <=12.85 micromol/L)	Number Analyzed	6 participants
		98.133 (56.5691)
Day 84: (>12.85 micromol/L)	Number Analyzed	12 participants
		95.950 (46.2820)

13. Secondary Outcome

Title	Summary of Trough Bosutinib Plasma Concentration by Creatinine Clearance
Description	Trough bosutinib plasma concentration is reported classified on basis of different ranges of creatinine clearance at baseline. Level range 1: <=71.479 milliliter per minute (mL/min), level rage 2: >71.479 and <=100.936 mL/min, level range 3: >100.936 and <=129.355 mL/min) and level range 4: >129.355 mL/min.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against each categories/levels respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Day 28: (<=71.479 mL/min)	Number Analyzed	7 participants
		75.039 (63.7599)
Day 28: (>71.479 and <=10 0.936 mL/min)	Number Analyzed	7 participants
		84.114 (49.0390)
Day 28: (>100.936 and <=1 29.355 mL/min)	Number Analyzed	10 participants
		100.100 (97.8388)
Day 28: (>129.355 mL/min)	Number Analyzed	10 participants
		72.610 (26.2392)
Day 56:(<=71.479 mL/min)	Number Analyzed	5 participants
		93.056 (56.2220)
Day 56:(>71.479 and <=10 0.936 mL/min)	Number Analyzed	11 participants
		92.764 (47.9905)
Day 56: (>100.936 and <=1 29.355 mL/min)	Number Analyzed	10 participants
		95.580 (58.4145)
Day 56: (>129.355 mL/min)	Number Analyzed	15 participants
		72.200 (32.9961)
Day 84: (<=71.479 mL/min)	Number Analyzed	10 participants
		92.540 (49.2182)
Day 84:(>71.479 and <=10 0.936 mL/min)	Number Analyzed	10 participants
		90.590 (45.9533)
Day 84:(>100.936 and <=1 29.355 mL/min)	Number Analyzed	11 participants
		69.100 (41.0767)
Day 84: (>129.355 mL/min)	Number Analyzed	13 participants
		70.277 (30.6643)

14. Secondary Outcome

Title	Summary of Trough Bosutinib Plasma Concentration by Aspartate Aminotransferase
Description	Trough bosutinib plasma concentration is reported classified on basis of different ranges of aspartate aminotransferase at baseline. Level range 1: <=22 units per liter (U/L), level rage 2: >22 and <=26 U/L, level range 3: >26 and <=33 U/L and level range 4: >33 U/L.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against each categories/levels respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Day 28: (<=22 U/L)	Number Analyzed	7 participants
		65.771 (26.3239)
Day 28: (>22 and <=26 U/L)	Number Analyzed	6 participants
		140.617 (120.1651)
Day 28: (>26 and <=33 U/L)	Number Analyzed	12 participants
		66.056 (37.4551)
Day 28: (>33 U/L)	Number Analyzed	9 participants
		82.711 (47.9527)
Day 56: (<=22 U/L)	Number Analyzed	12 participants
		82.117 (51.0937)
Day 56: (>22 and <=26 U/L)	Number Analyzed	8 participants
		76.050 (43.6907)
Day 56: (>26 and <=33 U/L)	Number Analyzed	12 participants
		93.607 (44.5087)
Day 56: (>33 U/L)	Number Analyzed	9 participants
		89.711 (50.6123)
Day 84: (<=22 U/L)	Number Analyzed	10 participants
		54.550 (23.4932)
Day 84: (>22 and <=26 U/L)	Number Analyzed	8 participants
		81.325 (55.3891)
Day 84: (>26 and <=33 U/L)	Number Analyzed	14 participants
		85.886 (39.3348)
Day 84: (>33 U/L)	Number Analyzed	12 participants
		92.208 (41.4203)

15. Secondary Outcome

Title	Summary of Trough Bosutinib Plasma Concentration by Alanine Aminotransferase
Description	Trough bosutinib plasma concentration is reported classified on basis of different ranges of alanine aminotransferase at baseline. Level range 1: <=17.5 U/L, level rage 2: >17.5 and <=25 U/L, level range 3: >25 and <=32 U/L and level range 4: >32 U/L.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against each categories/levels respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Day 28: (<=17.5 U/L)	Number Analyzed	7 participants
		49.111 (24.6077)
Day 28: (>17.5 and <=25 U/L)	Number Analyzed	6 participants
		98.882 (131.3382)
Day 28: (>25 and <=32 U/L)	Number Analyzed	12 participants
		94.175 (44.7227)
Day 28: (>32 U/L)	Number Analyzed	9 participants
		86.000 (39.7021)
Day 56: (<=17.5 U/L)	Number Analyzed	10 participants
		66.878 (33.4154)
Day 56: (>17.5 and <=25 U/L)	Number Analyzed	6 participants
		82.317 (69.6971)
Day 56: (>25 and <= 32 U/L)	Number Analyzed	12 participants
		104.350 (47.3634)
Day 56: (>32 U/L)	Number Analyzed	13 participants
		85.354 (40.1619)
Day 84: (<=17.5 U/L)	Number Analyzed	9 participants
		65.011 (43.4694)
Day 84: (>17.5 and <=25 U/L)	Number Analyzed	9 participants
		73.511 (43.4070)
Day 84: (>25 and <=32 U/L)	Number Analyzed	13 participants
		92.254 (49.1564)
Day 84: (>32 U/L)	Number Analyzed	13 participants
		81.462 (29.7583)

16. Secondary Outcome

Title	Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Diarrhea
Description	Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 diarrhea as "Yes" and "No" at specified time points. As per national cancer institute common terminology criteria (NCI-CTCAE) version 4.03, Grade 1: increase of <4 stools per day over baseline.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Yes: Day 28	Number Analyzed	28 participants
		85.585 (69.4219)
No: Day 28	Number Analyzed	6 participants
		74.133 (31.1208)
Yes: Day 56	Number Analyzed	36 participants
		86.086 (46.9140)
No: Day 56	Number Analyzed	5 participants
		85.080 (47.7414)
Yes: Day 84	Number Analyzed	37 participants
		85.219 (41.7195)
No: Day 84	Number Analyzed	7 participants
		50.271 (26.8976)

17. Secondary Outcome

Title	Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Nausea
Description	Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 Nausea as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: loss of appetite without alteration in eating habits.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Yes: Day 28	Number Analyzed	6 participants
		90.998 (72.5190)
No: Day 28	Number Analyzed	28 participants
		81.971 (63.5134)
Yes: Day 56	Number Analyzed	11 participants
		111.482 (54.9565)
No: Day 56	Number Analyzed	30 participants
		76.606 (39.8971)
Yes: Day 84	Number Analyzed	9 participants
		91.867 (57.5206)
No: Day 84	Number Analyzed	35 participants
		76.520 (36.7957)

18. Secondary Outcome

Title	Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Vomiting
Description	Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 vomiting as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: 1 - 2 episodes (separated by 5 minutes) in 24 hours.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Yes: Day 28	Number Analyzed	7 participants
		58.826 (29.1613)
No: Day 28	Number Analyzed	27 participants
		89.977 (69.3702)
Yes: Day 56	Number Analyzed	11 participants
		87.135 (53.5627)
No: Day 56	Number Analyzed	30 participants
		85.533 (44.5062)
Yes: Day 84	Number Analyzed	10 participants
		90.030 (32.1444)
No: Day 84	Number Analyzed	34 participants
		76.609 (43.8653)

19. Secondary Outcome

Title	Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Thrombocytopenia
Description	Trough bosutinib plasma concentration is reported classified on basis of presence/ or absence of grade 1 thrombocytopenia as "Yes" and "No" at specified time points. As per NCI-CTCAE version 4.03, Grade 1: platelet count decreased: 75.0 - 50.0*10^9/L.
Time Frame	Pre-dose on Day 28, Day 56 and Day 84 for trough bosutinib plasma concentration up to 12 March 2019; maximum of 22 months, approximately, for the adverse event of interest

Outcome Measure Data

Analysis Population Description

PK population included of all enrolled participants, who received at least 1 dose of study treatment and had at least 1 concentration of bosutinib on-treatment. For Day 28, 56, 84: total number of participants analyzed for each time point were sum of "number analyzed" against Yes and No categories respectively.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Mean (Standard Deviation); Unit of Measure: ng/mL
Yes: Day 28	Number Analyzed	3 participants
		80.167 (46.6352)
No: Day 28	Number Analyzed	31 participants
		83.893 (66.1379)
Yes: Day 56	Number Analyzed	5 participants
		87.700 (35.9669)
No: Day 56	Number Analyzed	36 participants
		85.722 (48.0957)
Yes: Day 84	Number Analyzed	3 participants
		75.067 (33.1815)
No: Day 84	Number Analyzed	41 participants
		79.995 (42.4024)

20. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs): National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or Higher
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention indicated AE. Grade 5 was death related to AE. Number of participants with Grade 3 or higher AEs are reported.
Time Frame	From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months)

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Count of Participants; Unit of Measure: Participants
	49 81.7%

21. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities, Chemistry: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4
Description	Laboratory parameters include: Alanine aminotransferase (ALT) increased: Grade 3: >5.0-20.0*upper limit of normal (ULN),Grade 4:>20.0*ULN, Alkaline phosphatase (ALP) increased: Grade 3: >5.0 - 20.0 x ULN, Grade 4: >20.0 x ULN, Aspartate aminotransferase (AST) increased: Grade 3: >5.0 - 20.0 *ULN, Grade 4: >20.0*ULN. Blood bilirubin increased:Grade 3:>3.0 - 10.0*ULN,Grade 4: >10.0*ULN, creatine phosphokinase (CPK) increased: Grade 3: >5*ULN-10*ULN, Grade 4: >10*ULN, Hyperglycemia: Grade 3: >250-500 milligrams/deciliter (mg/dL), Grade 4: >500 mg/dL. Hypermagnesemia: Grade 3: >3.0-8.0 mg/dL, Grade 4: >8.0 mg/dL, Hypokalemia: Grade 3: <3.0-2.5 millimoles/ liter (mmol/L), Grade 4:<2.5 mmol/L); Hyponatremia: Grade 3: <130-120 mmol/L, Grade 4: <120 mmol/L. Hypophosphatemia: Grade 3: <2.0-1.0 mg/dL, Grade 4: <1.0 mg/dL. Lipase increased: Grade 3:>2.0-5.0*ULN, Grade 4: >5.0*ULN. Serum amylase increased: Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0* ULN.
Time Frame	From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months)

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Measure Type: Count of Participants; Unit of Measure: Participants
ALT increased	Number Analyzed	60 participants
		30 50.0%
ALP increased	Number Analyzed	60 participants
		1 1.7%
AST increased	Number Analyzed	60 participants
		16 26.7%
Blood bilirubin increased	Number Analyzed	60 participants
		1 1.7%
CPK increased	Number Analyzed	60 participants
		3 5.0%
Hyperglycemia	Number Analyzed	60 participants
		2 3.3%
Hypermagnesemia	Number Analyzed	60 participants
		1 1.7%
Hypokalemia	Number Analyzed	60 participants
		2 3.3%
Hyponatremia	Number Analyzed	60 participants
		3 5.0%
Hypophosphatemia	Number Analyzed	60 participants
		3 5.0%
Lipase increased	Number Analyzed	60 participants
		14 23.3%
Serum amylase increased	Number Analyzed	60 participants
		1 1.7%
Creatinine increased	Number Analyzed	60 participants
		0 0.0%
Hypercalcemia	Number Analyzed	59 participants
		0 0.0%
Hyperkalemia	Number Analyzed	60 participants
		0 0.0%
Hypernatremia	Number Analyzed	60 participants
		0 0.0%
Hypoalbuminemia	Number Analyzed	60 participants
		0 0.0%
Hypocalcemia	Number Analyzed	59 participants
		0 0.0%
Hypoglycemia	Number Analyzed	60 participants
		0 0.0%
Hypomagnesemia	Number Analyzed	60 participants
		0 0.0%

22. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities, Hematology: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4
Description	Laboratory parameters include: Anemia: Grade 3: hemoglobin (Hgb) <8.0 g/dL, Grade 4: Life-threatening consequences; urgent intervention indicated, Lymphocyte count decreased: Grade 3: <500 - 200/millimeter(mm)^3, Grade 4: <200/mm^3, Neutrophil count decreased: Grade 3: <1000 - 500/mm^3, Grade 4: <500/mm^3, Platelet count decreased: Grade 3: <50.0 - 25.0*10^9 /L, Grade 4: <25.0*10^9 /L. White blood cell decreased: Grade 3: <2.0 - 1.0*10^9 /L, Grade 4: <1.0*10^9 /L. Only those rows in which at least 1 participant had data were reported.
Time Frame	From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months)

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Count of Participants; Unit of Measure: Participants
Anemia	4 6.7%
Lymphocyte count decreased	14 23.3%
Neutrophil count decreased	9 15.0%
Platelet count decreased	6 10.0%
White blood cell decreased	2 3.3%

23. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities, Coagulation: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3
Description	Coagulation parameters include: APTT prolonged (Grade 3: >2.5*ULN and hemorrhage), and INR increased (Grade 3 >2.5*ULN).
Time Frame	From first dose and up to 12 March 2019; maximum of 22 months, approximately

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Measure Type: Count of Participants; Unit of Measure: Participants
Activated partial thromboplastin time	Number Analyzed	60 participants
		0 0.0%
INR increased	Number Analyzed	56 participants
		0 0.0%

24. Secondary Outcome

Title	Number of Participants With Clinically Significant Vital Signs Findings
Description	Vital signs included: body weight Increase >= 10% change from baseline and Decrease >= 10% change from baseline, systolic blood pressure in millimeters of mercury (mmHg): <80 mmHg and >210 mmHg, diastolic blood pressure in mmHg: <40 mmHg and >130 mmHg, heart rate in beats per minute (bpm): <40 bpm and >150 bpm, temperature in degree Celsius (C): <32 and >40 degree C.
Time Frame	From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months)

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title		Bosutinib
Arm/Group Description:		Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed		60
Measure Type: Count of Participants; Unit of Measure: Participants
Body weight: Increase >= 10% change from baseline	Number Analyzed	58 participants
		12 20.7%
Body weight: Decrease >= 10% change from baseline	Number Analyzed	58 participants
		2 3.4%
Systolic blood pressure: <80 mmHg	Number Analyzed	58 participants
		0 0.0%
Systolic blood pressure: >210 mmHg	Number Analyzed	58 participants
		0 0.0%
Diastolic blood pressure: <40 mmHg	Number Analyzed	58 participants
		1 1.7%
Diastolic blood pressure: >130 mmHg	Number Analyzed	58 participants
		0 0.0%
Heart rate: <40 bpm	Number Analyzed	58 participants
		0 0.0%
Heart rate: >150 bpm	Number Analyzed	58 participants
		0 0.0%
Temperature: <32 C	Number Analyzed	60 participants
		0 0.0%
Temperature: >40 C	Number Analyzed	60 participants
		1 1.7%

25. Secondary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Description	ECG parameters included: QTc corrected by Bazett's (QTcB) interval: >500 msec (milliseconds), QTc corrected by Fridericia's (QTcF) interval: >500 msec and >450 msec (men) or >470 msec (women).
Time Frame	From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months)

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Count of Participants; Unit of Measure: Participants
QTcB interval: >500 msec	0 0.0%
QTcF interval: >500 msec	0 0.0%
QTcF interval: >450 msec (Men) or >470 msec (Women)	1 1.7%

26. Secondary Outcome

Title	Number of Participants Assessed for Left Ventricular Ejection Fraction
Description	Interpretation categories included: a) normal, b) abnormal, not clinically significant and c) abnormal, clinically significant.
Time Frame	At end of treatment for patients who discontinued treatment post initial dose (up to 12 March 2019)

Outcome Measure Data

Analysis Population Description

As-treated population included all enrolled participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	18
Measure Type: Count of Participants; Unit of Measure: Participants
Normal	15 83.3%
Abnormal, not clinically significant	3 16.7%
Abnormal, Clinically Significant	0 0.0%

27. Secondary Outcome

Title	Percentage of Participants With Major Molecular Response (MMR) at Months 3, 6, 9 and 18
Description	A MMR is defined as less than or equal to (<=) 0.1 percent (%) BCR-ABL transcripts on the international scale (IS), corresponding to a >=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the designated visit; any MMR gained and lost, or never achieved at or before the designated visit was considered as non-responder.
Time Frame	Month 3, 6, 9 and 18

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
Month 3	10.0; (3.6 to 16.4)
Month 6	50.0; (39.4 to 60.6)
Month 9	53.3; (42.7 to 63.9)
Month 18	61.7; (51.3 to 72.0)

28. Secondary Outcome

Title	Percentage of Participants With Molecular Response 1 (MR1) at Month 3
Description	MR1 is defined as <= 10% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory.
Time Frame	Month 3

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	80.0; (71.5 to 88.5)

29. Secondary Outcome

Title	Percentage of Participants With Molecular Response 2 (MR2) at Month 6
Description	MR2 is defined as <= 1% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	66.7; (56.7 to 76.7)

30. Secondary Outcome

Title	Percentage of Participants With Molecular Response 4.0 (MR4.0) and Molecular Response 4.5 (MR4.5) at Months 3, 6, 9 and 12
Description	MR4.0 defined as either: detectable disease with <= 0.01% BCR-ABL with a minimum of 9,800 ABL transcripts assessed by the central laboratory, or undetectable disease in cDNA with a minimum of 9,800 ABL transcripts assessed by the central laboratory. MR4.5 defined as either: detectable disease with <= 0.0032% BCR-ABL with a minimum of 30,990 ABL transcripts assessed by the central laboratory or undetectable disease in cDNA with a minimum of 30,990 ABL transcripts assessed by the central laboratory. The MMR value counted only if the response was demonstrated at the designated visit; any MMR gained and lost, or never achieved at or before the designated visit was considered as non-responder.
Time Frame	Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
MR4.0: Month 3	0; (0.0 to 0.0)
MR4.0: Month 6	18.3; (10.1 to 26.5)
MR4.0: Month 9	25.0; (15.8 to 34.2)
MR4.0: Month 12	31.7; (21.8 to 41.5)
MR4.5: Month 3	0; (0.0 to 0.0)
MR4.5: Month 6	8.3; (2.5 to 14.2)
MR4.5: Month 9	16.7; (8.8 to 24.6)
MR4.5: Month 12	21.7; (12.9 to 30.4)

31. Secondary Outcome

Title	Cumulative Incidence of Major Molecular Response (MMR) at Month 36
Description	Percentage of participants with MMR at Month 36. Cumulative incidence of MMR was measured from first dose to the first date of response. Documented participants who did not have an MMR response were censored at the last molecular assessment. A MMR is defined as <=0.1% BCR-ABL transcripts on the international scale, corresponding to a >=3-log reduction from standardized baseline with at least 3000 ABL assessed by the central laboratory. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	70.0; (60.3 to 79.7)

32. Secondary Outcome

Title	Cumulative Incidence of Molecular Response 4.0 (MR4.0) at Month 36
Description	Percentage of participants with MR4.0 at month 36. Cumulative incidence of MR4.0, was measured from first dose to the first date of MR 4.0. Documented participants who did not have an MR4.0 response were censored at the last molecular assessment. MR4.0 defined as either 1) detectable disease with <=0.01% BCR-ABL IS or 2) undetectable disease in cDNA with a minimum number of 9800 ABL transcripts specified by the central laboratory. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	50.0; (39.4 to 60.6)

33. Secondary Outcome

Title	Cumulative Incidence of Molecular Response 4.5 (MR4.5) at Month 36
Description	Percentage of participants with MR4.5 at Month 36. Cumulative incidence of MR 4.5 was measured from first dose to the first date of MR 4.5. Documented participants who did not have an MR4.5 response were censored at the last molecular assessment. MR 4.5 defined as either 1) detectable disease with <=0.0032% BCR-ABL IS or 2) undetectable disease in cDNA with a minimum number of 30990 ABL transcripts specified by the central laboratory in the same volume of cDNA used to test for BCR-ABL. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	46.7; (36.1 to 57.3)

34. Secondary Outcome

Title	Cumulative Incidence of Complete Cytogenetic Response (CCyR) at Month 36
Description	Percentage of participants with CCyR at Month 36. Cumulative incidence of CCyR, was measured from first dose to the first date of CCyR. Documented participants who did not have a CCyR response were censored at the last cytogenetic assessment. CCyR was defined as absence of detectable Philadelphia chromosome positive cells. CCyR was achieved when there were "0" Philadelphia chromosome positive metaphases among at least 20 metaphases from a bone marrow sample or when MMR was achieved if no bone marrow analysis was performed. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	80.0; (69.8 to 87.1)

35. Secondary Outcome

Title	Percentage of Participants With Cumulative Complete Haematological Response (CHR)
Description	CHR is based on peripheral blood assessment: WBC <=10*10^9/L, basophils <5% in blood, no myelocytes, promyelocytes, myeloblasts in the blood differential, platelet count <450* 10^9/L, spleen non-palpable. In the absence of extramedullary disease info, it was assumed that spleen was non-palpable. If CHR could not be assessed due to one or more missing components of CHR and participant had a MMR or a CCyR and all assessed components of CHR were within appropriate limits, then CHR was imputed using CCyR or MMR. CHR must be of at least 4 weeks in duration and confirmed by 2 assessments at least 4 weeks apart.
Time Frame	Up to Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	91.7; (85.8 to 97.5)

36. Secondary Outcome

Title	Cumulative Incidence of Transformation to Accelerated Phase (AP) and Blast Phase (BP) at Month 36
Description	Percentage of participants with transformation to AP and BP at Month 36. Transformation to AP or to BP CML defined as the time from first dose to the first date of transformation to accelerated phase or to blast phase CML. Documented participants who did not progress to AP or BP were censored at the last hematologic assessment. The transformation to AP or to BP was counted while participants were on treatment up to 28 days after last dose. Cumulative incidence: % of participants with event at month 36 adjusted for competing risk of treatment discontinuation without the event.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	60
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
	NA [1]; (NA to NA)

[1]

Number and 90% CI was not estimable as there were no participants with events.

37. Secondary Outcome

Title	Number of Participants With BCR-ABL Mutation at Treatment Discontinuation
Description	Mutation analysis was performed in case of either lack of response, suboptimal response or loss of response, or at the End of Treatment/Withdrawal visit.
Time Frame	Maximum up to 44 months of treatment

Outcome Measure Data

Analysis Population Description

The modified as-treated population included all enrolled participants with Philadelphia chromosome positive CP CML harboring b2a2 and/or b3a2 transcripts who received at least 1 dose of study treatment. Here, ''Overall Number of Participants Analyzed'' signifies participants with mutation testing.

Arm/Group Title	Bosutinib
Arm/Group Description:	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
Overall Number of Participants Analyzed	24
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%

Adverse Events

Time Frame	From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months)
Adverse Event Reporting Description	The total number of deaths occurring during study, from first dose and up to end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety population evaluated.
Arm/Group Title	Bosutinib
Arm/Group Description	Participants with newly diagnosed CP CML received bosutinib treatment, orally at a dose of 400 mg QD. In treatment phase, participants received bosutinib once daily for up to 12 months, which was extended further to at least additional 24 months (total of at least 36 months) or until end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. If participants discontinued the treatment phase only then they entered the long-term follow-up phase up to approximately 3 years after registration of the last participant, or until study termination, whichever comes first.
All-Cause Mortality
	Bosutinib
	Affected / at Risk (%)
Total	2/60 (3.33%)
Serious Adverse Events
	Bosutinib
	Affected / at Risk (%)
Total	14/60 (23.33%)
Eye disorders
Diabetic retinopathy * 1	1/60 (1.67%)
Gastrointestinal disorders
Diarrhoea * 1	2/60 (3.33%)
Vomiting * 1	1/60 (1.67%)
Ileus * 1	1/60 (1.67%)
General disorders
Pyrexia * 1	1/60 (1.67%)
Hepatobiliary disorders
Drug-induced liver injury * 1	1/60 (1.67%)
Liver disorder * 1	2/60 (3.33%)
Infections and infestations
Gastroenteritis * 1	1/60 (1.67%)
Pneumonia * 1	2/60 (3.33%)
Pyelonephritis * 1	1/60 (1.67%)
Sepsis * 1	1/60 (1.67%)
Wound infection * 1	1/60 (1.67%)
Influenza * 1	1/60 (1.67%)
Injury, poisoning and procedural complications
Ankle fracture * 1	1/60 (1.67%)
Investigations
Alanine aminotransferase increased * 1	1/60 (1.67%)
Aspartate aminotransferase increased * 1	1/60 (1.67%)
Metabolism and nutrition disorders
Dehydration * 1	2/60 (3.33%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer * 1	1/60 (1.67%)
Renal and urinary disorders
Acute kidney injury * 1	1/60 (1.67%)
Nephropathy toxic * 1	1/60 (1.67%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion * 1	1/60 (1.67%)
Skin and subcutaneous tissue disorders
Drug eruption * 1	1/60 (1.67%)
Erythema multiforme * 1	1/60 (1.67%)
1 Term from vocabulary, MedDRA v23.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Bosutinib
	Affected / at Risk (%)
Total	60/60 (100.00%)
Blood and lymphatic system disorders
Anaemia * 1	10/60 (16.67%)
Lymphopenia * 1	4/60 (6.67%)
Thrombocytopenia * 1	5/60 (8.33%)
Gastrointestinal disorders
Abdominal pain upper * 1	6/60 (10.00%)
Constipation * 1	8/60 (13.33%)
Diarrhoea * 1	52/60 (86.67%)
Nausea * 1	17/60 (28.33%)
Vomiting * 1	16/60 (26.67%)
Stomatitis * 1	6/60 (10.00%)
General disorders
Pyrexia * 1	15/60 (25.00%)
Hepatobiliary disorders
Liver disorder * 1	7/60 (11.67%)
Infections and infestations
Influenza * 1	6/60 (10.00%)
Nasopharyngitis * 1	23/60 (38.33%)
Upper respiratory tract infection * 1	8/60 (13.33%)
Gastroenteritis * 1	5/60 (8.33%)
Investigations
Alanine aminotransferase increased * 1	33/60 (55.00%)
Amylase increased * 1	10/60 (16.67%)
Aspartate aminotransferase increased * 1	28/60 (46.67%)
Blood alkaline phosphatase increased * 1	16/60 (26.67%)
Blood creatine phosphokinase increased * 1	6/60 (10.00%)
Gamma-glutamyltransferase increased * 1	11/60 (18.33%)
Lipase increased * 1	17/60 (28.33%)
Lymphocyte count decreased * 1	7/60 (11.67%)
Neutrophil count decreased * 1	7/60 (11.67%)
Platelet count decreased * 1	13/60 (21.67%)
White blood cell count decreased * 1	5/60 (8.33%)
Blood creatinine increased * 1	6/60 (10.00%)
Metabolism and nutrition disorders
Hypocalcaemia * 1	5/60 (8.33%)
Hypokalaemia * 1	4/60 (6.67%)
Musculoskeletal and connective tissue disorders
Back pain * 1	10/60 (16.67%)
Myalgia * 1	5/60 (8.33%)
Pain in extremity * 1	4/60 (6.67%)
Arthralgia * 1	9/60 (15.00%)
Nervous system disorders
Headache * 1	7/60 (11.67%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion * 1	8/60 (13.33%)
Upper respiratory tract inflammation * 1	5/60 (8.33%)
Skin and subcutaneous tissue disorders
Dermatitis acneiform * 1	4/60 (6.67%)
Eczema asteatotic * 1	4/60 (6.67%)
Photosensitivity reaction * 1	4/60 (6.67%)
Pruritus * 1	4/60 (6.67%)
Rash * 1	18/60 (30.00%)
Rash maculo-papular * 1	8/60 (13.33%)
Eczema * 1	4/60 (6.67%)
Urticaria * 1	4/60 (6.67%)
Vascular disorders
Hypertension * 1	4/60 (6.67%)
1 Term from vocabulary, MedDRA v23.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ono T, Hino M, Matsumura I, Fujisawa S, Ishizawa K, Sakaida E, Sekiguchi N, Ono C, Aizawa M, Tanetsugu Y, Koide Y, Takahashi N. Bosutinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia: final 3-year follow-up results of a phase 2 study. Int J Hematol. 2022 Dec;116(6):871-882. doi: 10.1007/s12185-022-03435-4. Epub 2022 Aug 13.

Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

Hino M, Matsumura I, Fujisawa S, Ishizawa K, Ono T, Sakaida E, Sekiguchi N, Tanetsugu Y, Fukuhara K, Ohkura M, Koide Y, Takahashi N. Phase 2 study of bosutinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia. Int J Hematol. 2020 Jul;112(1):24-32. doi: 10.1007/s12185-020-02878-x. Epub 2020 Apr 11.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03128411
• Other Study ID Numbers: B1871048
• First Submitted: March 28, 2017
• First Posted: April 25, 2017
• Results First Submitted: March 12, 2020
• Results First Posted: November 24, 2020
• Last Update Posted: May 19, 2022