| Primary | Percentage of Participants With Major Molecular Response (MMR) at Month 12 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Month 12 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| | 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 |
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| 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%. | z-test, 1-sided | | <0.0001 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Percentage of Participants With Major Molecular Response (MMR) by Month 12 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Major Molecular Response (MMR) by Month 18 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Up to Month 18 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Up to Month 12 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Probability of Maintaining Major Molecular Response (MMR) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Probability of Maintaining Complete Cytogenetic Response (CCyR) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Cumulative Incidence of Event Free Survival (EFS) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Probability of Overall Survival (OS) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Trough Plasma Concentrations of Bosutinib | | 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. | Posted | | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | | Pre-dose on Day 1, Day 28, Day 56, Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary and Analysis of Trough Bosutinib Plasma Concentration by Major Molecular Response (MMR) Response | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28, Day 56 and Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary and Analysis of Trough Bosutinib Plasma Concentration by CCyR Response | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28, Day 56 and Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary of Trough Bosutinib Plasma Concentration by Total Bilirubin | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28, Day 56 and Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary of Trough Bosutinib Plasma Concentration by Creatinine Clearance | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28, Day 56 and Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary of Trough Bosutinib Plasma Concentration by Aspartate Aminotransferase | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28, Day 56 and Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary of Trough Bosutinib Plasma Concentration by Alanine Aminotransferase | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28, Day 56 and Day 84 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Diarrhea | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 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 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Nausea | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 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 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Vomiting | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 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 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Summary and Analysis of Trough Bosutinib Plasma Levels by Presence/Absence Grade 1: Thrombocytopenia | 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. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | 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 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | 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 | 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. | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants With Laboratory Abnormalities, Chemistry: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4 | 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. | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants With Laboratory Abnormalities, Hematology: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 or 4 | 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. | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants With Laboratory Abnormalities, Coagulation: National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) Grade 3 | Coagulation parameters include: APTT prolonged (Grade 3: >2.5*ULN and hemorrhage), and INR increased (Grade 3 >2.5*ULN). | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | From first dose and up to 12 March 2019; maximum of 22 months, approximately | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants With Clinically Significant Vital Signs Findings | 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. | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 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). | As-treated population included all enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | From first dose and up to 28 days after the last dose of study drug (maximum up to 45 months) | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants Assessed for Left Ventricular Ejection Fraction | Interpretation categories included: a) normal, b) abnormal, not clinically significant and c) abnormal, clinically significant. | 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. | Posted | | Count of Participants | | Participants | | At end of treatment for patients who discontinued treatment post initial dose (up to 12 March 2019) | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Major Molecular Response (MMR) at Months 3, 6, 9 and 18 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Month 3, 6, 9 and 18 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Molecular Response 1 (MR1) at Month 3 | MR1 is defined as <= 10% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Molecular Response 2 (MR2) at Month 6 | MR2 is defined as <= 1% BCR-ABL with a minimum of 3,000 ABL transcripts assessed by the central laboratory. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Month 6 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Molecular Response 4.0 (MR4.0) and Molecular Response 4.5 (MR4.5) at Months 3, 6, 9 and 12 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Months 3, 6, 9 and 12 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Cumulative Incidence of Major Molecular Response (MMR) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Cumulative Incidence of Molecular Response 4.0 (MR4.0) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Cumulative Incidence of Molecular Response 4.5 (MR4.5) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Cumulative Incidence of Complete Cytogenetic Response (CCyR) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Up to Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Cumulative Incidence of Transformation to Accelerated Phase (AP) and Blast Phase (BP) at Month 36 | 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. | 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. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Month 36 | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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| Secondary | Number of Participants With BCR-ABL Mutation at Treatment Discontinuation | 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. | 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. | Posted | | Count of Participants | | Participants | | Maximum up to 44 months of treatment | | | | ID | Title | Description |
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| OG000 | Bosutinib | 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. |
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