Bosutinib For Autosomal Dominant Polycystic Kidney Disease | NCT01233869

ID	Type	Description	Link
3160A7-2211	Other Identifier	Alias Study Number
2010-023017-65	EudraCT Number

Label	Type	Intervention Names
Cohort A	Experimental	Drug: Bosutinib
Cohort B	Experimental	Drug: Bosutinib
Cohort C	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Bosutinib	Drug	Once daily oral dose of 200 mg of bosutinib	Cohort A

Measure	Description	Time Frame
Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25	TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).	Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])

Measure	Description	Time Frame
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination	eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Kidney Institute, PLC		Phoenix	Arizona	85004	United States
Southwest Clinical Research Institute, LLC

PubMed Identifier	Type	Citation	Retractions
39356039	Derived	St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
28838955	Derived

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25

TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).

The modified intent-to-treat (mITT) population included all participants who were randomized and received at least 2-weeks' worth of treatment and have at least 1 follow-up MRI assessment that was preceded by a 1-month washout of the study drug; n=the number of participants analyzed at that time point in the respective arms.

Posted

Mean

Standard Deviation

centimeter cube (cm^3)

Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG003	Placebo	Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.

Units	Counts
Participants	OG00027 OG0016 OG00221 OG003

Title

Denominators

Categories

Baseline (n=27,6,21,33)

Title	Measurements
	OG0001686.38± 944.30 OG0011418.96± 629.34 OG0021487.48± 531.96 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.	Mixed Models Analysis		<0.0001		Median Difference (Final Values)	3.86			2-Sided	95	2.02	5.74				No	Superiority or Other
OG000 OG002

Secondary

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination

eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.

The mITT population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment; n=the number of participants analyzed at that time point in the respective arms.

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Secondary

Time to First Occurrence or Worsening of Hypertension

The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.

The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).

Posted

Number

days

Baseline up to Month 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002

Secondary

Time to First Occurrence or Worsening of Back and/or Flank Pain

The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.

Posted

Number

days

Baseline up to Month 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Secondary

Time to First Occurrence of Gross Hematuria

Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.

Posted

Number

days

Baseline up to Month 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day

Secondary

Time to First Occurrence of Proteinuria

Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.

Posted

Number

days

Baseline up to Month 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day

Secondary

Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days

ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.

Posted

Number

days

Baseline up to Month 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002

Secondary

Number of Participants With High Blood Urea Nitrogen (BUN) Levels

A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day

Secondary

Number of Participants With High Serum Creatinine (SCr) Levels

A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day

Secondary

Maximum Observed Plasma Concentration (Cmax) of Bosutinib

The pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms per milliliter (ng/mL)

Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib

The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.

Posted

Median

Full Range

hours

Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.

Secondary

Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib

Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*hr/mL

Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002

Secondary

Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib

The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.

Secondary

Apparent Oral Clearance (CL/F) of Bosutinib

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

L/hr

Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Secondary

Apparent Volume of Distribution (Vz/F) of Bosutinib

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore Vz/F was not reported.

Posted

Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Secondary

Terminal Elimination Half-Life (t1/2) of Bosutinib

t1/2 is the time measured for the plasma concentration to decrease by one half.

Posted

Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day

Secondary

Observed Accumulation Ratio (Rac) of Bosutinib

Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).

The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
OG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.

Secondary

Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25

The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.

Posted

Mean

Standard Deviation

units on a scale

Baseline and end of ITPV (Month 25)

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to 30 days after last study drug administration

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Other Pre-specified

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to 30 days after last study drug administration

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day

Other Pre-specified

Number of Participants With Potentially Clinically Significant Vital Signs Findings

Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.

The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.

Posted

Number

participants

Baseline up to 30 days after last study drug administration

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Other Pre-specified

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings

ECGs were centrally evaluated. ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (≥)300 milliseconds (msec) or ≥25% increase when baseline is greater than (>)200 msec and ≥50% increase when baseline is less than or equal to (≤)200 msec; QRS interval ≥200 msec or ≥25%/50% increase from baseline; and QTcF ≥450 msec or ≥30 msec increase.

The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.

Posted

Number

participants

Baseline up to 30 days after last study drug administration

ID	Title	Description
OG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
OG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0007 affected58 at risk EG0014 affected31 at risk EG0025 affected24 at risk EG0032 affected56 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected31 at risk EG0021 affected24 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0022 affected24 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected31 at risk EG0022 affected24 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0004 affected58 at risk EG0018 affected31 at risk EG0022 affected24 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0005 affected58 at risk EG0017 affected31 at risk EG0028 affected24 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected31 at risk EG0021 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG00026 affected58 at risk EG00126 affected31 at risk EG00218 affected24 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0006 affected58 at risk EG0012 affected31 at risk EG0023 affected24 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG00021 affected58 at risk EG00115 affected31 at risk EG00213 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0006 affected58 at risk EG00111 affected31 at risk EG0029 affected24 at risk EG003
Asthenia	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected31 at risk EG0023 affected24 at risk EG003
Chest pain	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0012 affected31 at risk EG0020 affected24 at risk EG003
Fatigue	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0004 affected58 at risk EG0018 affected31 at risk EG0022 affected24 at risk EG003
Influenza-like illness	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0023 affected24 at risk EG003
Oedema peripheral	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0021 affected24 at risk EG003
Pain	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Pyrexia	General disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0013 affected31 at risk EG0022 affected24 at risk EG003
Hepatocellular injury	Hepatobiliary disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0020 affected24 at risk EG003
Bronchitis	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected31 at risk EG0022 affected24 at risk EG003
Cystitis	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected31 at risk EG0023 affected24 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected31 at risk EG0021 affected24 at risk EG003
Influenza	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected31 at risk EG0021 affected24 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG00012 affected58 at risk EG0013 affected31 at risk EG0028 affected24 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected31 at risk EG0023 affected24 at risk EG003
Rhinitis	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected31 at risk EG0022 affected24 at risk EG003
Sinusitis	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0006 affected58 at risk EG0014 affected31 at risk EG0027 affected24 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0008 affected58 at risk EG0012 affected31 at risk EG0022 affected24 at risk EG003
Vaginal infection	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected28 at risk EG0010 affected14 at risk EG0020 affected15 at risk EG003
Viral infection	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected31 at risk EG0021 affected24 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected31 at risk EG0021 affected24 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG00018 affected58 at risk EG00116 affected31 at risk EG00212 affected24 at risk EG003
Amylase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0014 affected31 at risk EG0023 affected24 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG00017 affected58 at risk EG00111 affected31 at risk EG0026 affected24 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG00011 affected58 at risk EG0013 affected31 at risk EG0026 affected24 at risk EG003
Blood creatinine increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0022 affected24 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected31 at risk EG0020 affected24 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected31 at risk EG0020 affected24 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0004 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected31 at risk EG0022 affected24 at risk EG003
Lipase increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0005 affected58 at risk EG0016 affected31 at risk EG0026 affected24 at risk EG003
Weight increased	Investigations	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected31 at risk EG0023 affected24 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0014 affected31 at risk EG0024 affected24 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected31 at risk EG0022 affected24 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0005 affected58 at risk EG0010 affected31 at risk EG0021 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0009 affected58 at risk EG0012 affected31 at risk EG0021 affected24 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG00010 affected58 at risk EG0015 affected31 at risk EG0020 affected24 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected31 at risk EG0020 affected24 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected31 at risk EG0022 affected24 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Dizziness	Nervous system disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0007 affected58 at risk EG0012 affected31 at risk EG0024 affected24 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected31 at risk EG0020 affected24 at risk EG003
Headache	Nervous system disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0009 affected58 at risk EG0013 affected31 at risk EG0022 affected24 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected31 at risk EG0020 affected24 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0004 affected58 at risk EG0013 affected31 at risk EG0021 affected24 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected31 at risk EG0022 affected24 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0022 affected24 at risk EG003
Amenorrhoea	Reproductive system and breast disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected28 at risk EG0011 affected14 at risk EG0020 affected15 at risk EG003
Vaginal inflammation	Reproductive system and breast disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected28 at risk EG0010 affected14 at risk EG0021 affected15 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0013 affected31 at risk EG0023 affected24 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0005 affected58 at risk EG0012 affected31 at risk EG0021 affected24 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0004 affected58 at risk EG0010 affected31 at risk EG0020 affected24 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected31 at risk EG0023 affected24 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected31 at risk EG0022 affected24 at risk EG003
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0012 affected31 at risk EG0021 affected24 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected31 at risk EG0020 affected24 at risk EG003
Hypertension	Vascular disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0008 affected58 at risk EG0013 affected31 at risk EG0025 affected24 at risk EG003
Hypotension	Vascular disorders	MedDRA (v17.0)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected31 at risk EG0023 affected24 at risk EG003

ID	Term
D007690	Polycystic Kidney Diseases
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D000015	Abnormalities, Multiple
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D000072661	Ciliopathies
D030342	Genetic Diseases, Inborn

ID	Title	Description
BG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
BG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
BG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
BG003	Placebo	Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bosutinib 200 mg/Day	Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.	12	58	56	58
EG001	Bosutinib 400 mg/Day	Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.	4	31	30	31
EG002	Bosutinib 400/200 mg/Day	Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.	6	24	23	24
EG003	Placebo	Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.	5	56	50	56