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| Name | Class |
|---|---|
| pH Associates | UNKNOWN |
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The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Myeloid Leukaemia | Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib | Drug | Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (<) 450*10^9 per liter, white blood cells count <10*10^9 per liter, no immature granulocytes and <5 percent (%) basophils on differential and a non-palpable spleen. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Partial Haematological Response (PHR) | Haematological response used blood sample of the participants to evaluate response to treatment for CML. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator. | Baseline up to 5.5 years |
| Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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CML out-patient clinics
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Liverpool Hospital | Liverpool | Merseyside | L7 8XP | United Kingdom | ||
| Hammersmith Hospital |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bosutinib | Participants with Philadelphia chromosome-positive chronic myeloid leukemia (CML) receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 milligram (mg), were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved Summary of Product Characteristics (SmPC). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bosutinib | Participants with Philadelphia chromosome-positive CML receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 mg, were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved SmPC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (<) 450*10^9 per liter, white blood cells count <10*10^9 per liter, no immature granulocytes and <5 percent (%) basophils on differential and a non-palpable spleen. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
Baseline up to 5.5 years
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosutinib | Participants with Philadelphia chromosome-positive CML receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 mg, were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved SmPC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C471992 | bosutinib |
Not provided
Not provided
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|
| Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with <0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with <0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with >32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. | Baseline up to 5.5 years |
| Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (<=) 0.1% on the IS. | Baseline up to 5.5 years |
Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. |
| Baseline up to 5.5 years |
| Progression-free Survival (PFS) | PFS was defined as the duration between initiation of Bosutinib therapy and date of progression estimated by the treating physician or death of participant (all causes combined). Progression was defined as change from chronic phase of CML (CP-CML) to accelerated phase of CML (AP-CML) or to blast crisis of CML (BC-CML). CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. Participants who were alive at the date of last assessment were censored on the date of data collection. | Year 1, 2, 3 |
| Overall Survival (OS) | OS was defined as the duration from initiation of Bosutinib therapy to date of death (all causes combined). For participants who were alive or lost to follow-up (LTFU), overall survival was censored on the date of data collection or date LTFU, respectively. | From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3 |
| Percentage of Participants With Disease Progression | Progression was defined as change from CP-CML to AP-CML or to BC-CML. CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. | Year 1, 2, 3 |
| Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Baseline up to 5.5 years |
| Cross-Intolerance Between Bosutinib and Previous Therapy | Cross-intolerance was defined as percentage of participants who permanently discontinued bosutinib due to an adverse event which also resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib). | Baseline up to 5.5 years |
| Mean Dose of Bosutinib at Initiation of Treatment | Baseline up to 5.5 years |
| Relative Bosutinib Dose Intensity | Relative dose intensity was defined as the percentage of daily dose received over the expected daily dose of the study drug. | Baseline up to 5.5 years |
| Duration of Bosutinib Therapy | The duration from initiation of Bosutinib therapy up to the end of Bosutinib therapy was reported in this outcome measure. | Baseline up to 5.5 years |
| London |
| W12 0HS |
| United Kingdom |
| Nottingham University Hospital | Nottingham | NG5 1PB | United Kingdom |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With Cumulative Partial Haematological Response (PHR) | Haematological response used blood sample of the participants to evaluate response to treatment for CML. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with <0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with <0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with >32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Primary | Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (<=) 0.1% on the IS. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Secondary | Percentage of Participants With Treatment Related Adverse Events (AEs) | Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Secondary | Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3 | Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the duration between initiation of Bosutinib therapy and date of progression estimated by the treating physician or death of participant (all causes combined). Progression was defined as change from chronic phase of CML (CP-CML) to accelerated phase of CML (AP-CML) or to blast crisis of CML (BC-CML). CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. Participants who were alive at the date of last assessment were censored on the date of data collection. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Median | 95% Confidence Interval | years | Year 1, 2, 3 |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the duration from initiation of Bosutinib therapy to date of death (all causes combined). For participants who were alive or lost to follow-up (LTFU), overall survival was censored on the date of data collection or date LTFU, respectively. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Median | 95% Confidence Interval | years | From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3 |
|
|
|
| Secondary | Percentage of Participants With Disease Progression | Progression was defined as change from CP-CML to AP-CML or to BC-CML. CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure and number analyzed (n) signifies those participants who were evaluable at specified time points only. | Posted | Number | percentage of participants | Year 1, 2, 3 |
|
|
|
| Secondary | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Secondary | Cross-Intolerance Between Bosutinib and Previous Therapy | Cross-intolerance was defined as percentage of participants who permanently discontinued bosutinib due to an adverse event which also resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib). | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Number | percentage of participants | Baseline up to 5.5 years |
|
|
|
| Secondary | Mean Dose of Bosutinib at Initiation of Treatment | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Mean | Standard Deviation | milligram per day | Baseline up to 5.5 years |
|
|
|
| Secondary | Relative Bosutinib Dose Intensity | Relative dose intensity was defined as the percentage of daily dose received over the expected daily dose of the study drug. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Number | percentage of daily dose | Baseline up to 5.5 years |
|
|
|
| Secondary | Duration of Bosutinib Therapy | The duration from initiation of Bosutinib therapy up to the end of Bosutinib therapy was reported in this outcome measure. | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | Posted | Median | Full Range | months | Baseline up to 5.5 years |
|
|
|
| 17 |
| 87 |
| 81 |
| 87 |
| Creatinine increased | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Alopecia | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Asthenia | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Chest pain | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Fatigue | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Oedema | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Pain | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Pyrexia | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Other | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Hepatobiliary disorders | No coding dictionary | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | No coding dictionary | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | No coding dictionary | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | No coding dictionary | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | No coding dictionary | Non-systematic Assessment |
|
| Headache | Nervous system disorders | No coding dictionary | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Pregnancy | Reproductive system and breast disorders | No coding dictionary | Non-systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | No coding dictionary | Non-systematic Assessment |
|
| Diseases of the eye | Eye disorders | No coding dictionary | Non-systematic Assessment |
|
| Lack of efficacy | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Haematological - not determined | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Creatinine increased | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | No coding dictionary | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Alopecia | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Asthenia | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Chest pain | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Fatigue | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Oedema | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Pain | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Pyrexia | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Other | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Hepatobiliary disorders | No coding dictionary | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | No coding dictionary | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | No coding dictionary | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | No coding dictionary | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | No coding dictionary | Non-systematic Assessment |
|
| Headache | Nervous system disorders | No coding dictionary | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Lack of efficacy | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Haematological - not determined | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Depression | Nervous system disorders | No coding dictionary | Non-systematic Assessment |
|
| Diseases of the eye | Eye disorders | No coding dictionary | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | No coding dictionary | Non-systematic Assessment |
|
| Altered skin sensation | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Breaking nails | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | No coding dictionary | Non-systematic Assessment |
|
| Exostosis - benign growths of bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | No coding dictionary | Non-systematic Assessment |
|
| Fever | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Flu like symptoms | Infections and infestations | No coding dictionary | Non-systematic Assessment |
|
| Medication error | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Rigors associates with extreme tiredness and thirst | General disorders | No coding dictionary | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Sleep disturbance | Nervous system disorders | No coding dictionary | Non-systematic Assessment |
|
| General disorders | No coding dictionary | Non-systematic Assessment |
|
| Unusual taste in mouth | Gastrointestinal disorders | No coding dictionary | Non-systematic Assessment |
|
| Vitamin D deficiency | Musculoskeletal and connective tissue disorders | No coding dictionary | Non-systematic Assessment |
|
| Weight gain | General disorders | No coding dictionary | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 3 year |
|
|
| Title | Measurements |
|---|---|
|
| Participant request |
|
| Death |
|
| Disease progression |
|
| Other |
|