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Trial record 20 of 637 for:    Russian Federation | Chile

Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

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ClinicalTrials.gov Identifier: NCT00574873
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : November 5, 2012
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Myeloid Leukemia
Interventions Drug: Bosutinib
Drug: imatinib
Enrollment 502
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily. Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Period Title: Overall Study
Started 250 252
Treated 248 251
Completed 12 1
Not Completed 238 251
Reason Not Completed
Withdrawal by Subject             18             19
Investigator request             18             8
Death             15             14
Lost to Follow-up             14             5
Other             40             4
Discontinuation of study by sponsor             5             199
Blank, site closed per local regulations             2             2
Extension Study             126             0
Arm/Group Title Bosutinib Imatinib Total
Hide Arm/Group Description Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily. Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 250 252 502
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population - included all participants who were randomized to test article.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 250 participants 252 participants 502 participants
47.4  (14.39) 45.6  (14.80) 46.5  (14.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants 252 participants 502 participants
Female
101
  40.4%
117
  46.4%
218
  43.4%
Male
149
  59.6%
135
  53.6%
284
  56.6%
1.Primary Outcome
Title Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
Hide Description Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.
Time Frame Year 1 (48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - included all participants who were randomized to test article.
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description:
Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Overall Number of Participants Analyzed 250 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
70.0
(64.3 to 75.7)
68.3
(62.5 to 74.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bosutinib, Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.667
Comments p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.
Method Stratified Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Major Molecular Response (MMR) at Year 1
Hide Description Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to [≥] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.
Time Frame Year 1 (48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description:
Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Overall Number of Participants Analyzed 250 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
38.0
(32.0 to 44.0)
25.4
(20.0 to 30.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bosutinib, Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.
Method Stratified Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks
Hide Description

The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment.

CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or <1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.

The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1.

Time Frame 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of participants from ITT population who had CCyR.
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description:
Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Overall Number of Participants Analyzed 197 204
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
92.9
(87.8 to 95.9)
88.9
(83.2 to 92.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bosutinib, Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.31 to 1.31
Estimation Comments Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.
4.Secondary Outcome
Title Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks
Hide Description

The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment.

CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, absolute neutrophil count ≥1.0*10^9/L, platelets ≥100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly).

The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1.

Time Frame 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of participants from ITT population who had CHR.
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description:
Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Overall Number of Participants Analyzed 219 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
91.6
(86.5 to 94.9)
86.0
(80.7 to 90.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bosutinib, Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.32 to 1.08
Estimation Comments Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.
5.Secondary Outcome
Title Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks
Hide Description

The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment.

Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.

The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2.

Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of participants from ITT population who had MMR.
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description:
Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Overall Number of Participants Analyzed 168 170
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
94.7
(89.6 to 97.3)
98.0
(93.8 to 99.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bosutinib, Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.25
Confidence Interval (2-Sided) 95%
0.90 to 11.72
Estimation Comments Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.
6.Secondary Outcome
Title Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks
Hide Description

The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant.

Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets <100*10^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas).

Time to transformation was calculated as weeks = ([date of first documented occurrence of the event - date of randomization] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray’s method.

Time Frame 192 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description:
Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
Overall Number of Participants Analyzed 250 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
1.6
(0.6 to 4.3)
4.4
(2.5 to 7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bosutinib, Imatinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.13 to 1.29
Estimation Comments The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Bosutinib Imatinib
Hide Arm/Group Description Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily. Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
All-Cause Mortality
Bosutinib Imatinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bosutinib Imatinib
Affected / at Risk (%) Affected / at Risk (%)
Total   90/248 (36.29%)   57/251 (22.71%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  5/248 (2.02%)  7/251 (2.79%) 
Anaemia * 1  6/248 (2.42%)  8/251 (3.19%) 
Neutropenia * 1  2/248 (0.81%)  5/251 (1.99%) 
Iron deficiency anaemia * 1  1/248 (0.40%)  0/251 (0.00%) 
Leukocytosis * 1  1/248 (0.40%)  0/251 (0.00%) 
Leukopenia * 1  0/248 (0.00%)  1/251 (0.40%) 
Cardiac disorders     
Coronary artery disease * 1  3/248 (1.21%)  0/251 (0.00%) 
Arteriosclerosis coronary artery * 1  1/248 (0.40%)  1/251 (0.40%) 
Pericardial effusion * 1  5/248 (2.02%)  0/251 (0.00%) 
Angina pectoris * 1  0/248 (0.00%)  1/251 (0.40%) 
Atrial fibrillation * 1  1/248 (0.40%)  0/251 (0.00%) 
Atrioventricular block complete * 1  0/248 (0.00%)  1/251 (0.40%) 
Bundle branch block right * 1  1/248 (0.40%)  0/251 (0.00%) 
Cardiac failure * 1  0/248 (0.00%)  1/251 (0.40%) 
Cardiac failure congestive * 1  2/248 (0.81%)  0/251 (0.00%) 
Pericarditis * 1  2/248 (0.81%)  0/251 (0.00%) 
Ear and labyrinth disorders     
Deafness unilateral * 1  1/248 (0.40%)  0/251 (0.00%) 
Vertigo * 1  0/248 (0.00%)  1/251 (0.40%) 
Endocrine disorders     
Goitre * 1  0/248 (0.00%)  1/251 (0.40%) 
Eye disorders     
Vitreous haemorrhage * 1  0/248 (0.00%)  1/251 (0.40%) 
Visual impairment * 1  1/248 (0.40%)  1/251 (0.40%) 
Cataract * 1  1/248 (0.40%)  1/251 (0.40%) 
Glaucoma * 1  1/248 (0.40%)  0/251 (0.00%) 
Retinopathy * 1  1/248 (0.40%)  0/251 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  9/248 (3.63%)  0/251 (0.00%) 
Pancreatitis * 1  1/248 (0.40%)  3/251 (1.20%) 
Vomiting * 1  3/248 (1.21%)  2/251 (0.80%) 
Gastritis * 1  2/248 (0.81%)  0/251 (0.00%) 
Abdominal pain lower * 1  0/248 (0.00%)  1/251 (0.40%) 
Anal fistula * 1  1/248 (0.40%)  0/251 (0.00%) 
Enteritis * 1  1/248 (0.40%)  0/251 (0.00%) 
Gastric haemorrhage * 1  1/248 (0.40%)  0/251 (0.00%) 
Gastric ulcer * 1  2/248 (0.81%)  0/251 (0.00%) 
Gastrointestinal disorder * 1  1/248 (0.40%)  0/251 (0.00%) 
Gastrointestinal necrosis * 1  1/248 (0.40%)  0/251 (0.00%) 
Mesenteric artery embolism * 1  1/248 (0.40%)  0/251 (0.00%) 
Nausea * 1  1/248 (0.40%)  2/251 (0.80%) 
Pancreatitis acute * 1  1/248 (0.40%)  0/251 (0.00%) 
Peritoneal haemorrhage * 1  0/248 (0.00%)  1/251 (0.40%) 
Rectal haemorrhage * 1  0/248 (0.00%)  1/251 (0.40%) 
Small intestinal obstruction * 1  1/248 (0.40%)  1/251 (0.40%) 
Upper gastrointestinal haemorrhage * 1  0/248 (0.00%)  1/251 (0.40%) 
Alcoholic pancreatitis * 1  0/248 (0.00%)  1/251 (0.40%) 
Faecaloma * 1  1/248 (0.40%)  0/251 (0.00%) 
Proctitis * 1  0/248 (0.00%)  1/251 (0.40%) 
Rectal polyp * 1  1/248 (0.40%)  0/251 (0.00%) 
Umbilical hernia * 1  1/248 (0.40%)  0/251 (0.00%) 
Gastritis haemorrhagic * 1  1/248 (0.40%)  0/251 (0.00%) 
Abdominal pain * 1  3/248 (1.21%)  1/251 (0.40%) 
General disorders     
Pyrexia * 1  7/248 (2.82%)  2/251 (0.80%) 
Generalised oedema * 1  0/248 (0.00%)  1/251 (0.40%) 
Oedema * 1  0/248 (0.00%)  1/251 (0.40%) 
Pain * 1  1/248 (0.40%)  0/251 (0.00%) 
Disease progression * 1  0/248 (0.00%)  1/251 (0.40%) 
Sudden death * 1  1/248 (0.40%)  0/251 (0.00%) 
Hepatobiliary disorders     
Drug-induced liver injury * 1  1/248 (0.40%)  0/251 (0.00%) 
Cholecystitis chronic * 1  1/248 (0.40%)  0/251 (0.00%) 
Cholelithiasis * 1  1/248 (0.40%)  1/251 (0.40%) 
Allergic hepatitis * 1  0/248 (0.00%)  1/251 (0.40%) 
Cholecystitis * 1  0/248 (0.00%)  1/251 (0.40%) 
Gallbladder polyp * 1  1/248 (0.40%)  0/251 (0.00%) 
Immune system disorders     
Anaphylactic shock * 1  2/248 (0.81%)  0/251 (0.00%) 
Drug hypersensitivity * 1  1/248 (0.40%)  0/251 (0.00%) 
Infections and infestations     
Pneumonia * 1  8/248 (3.23%)  1/251 (0.40%) 
Bronchitis * 1  2/248 (0.81%)  1/251 (0.40%) 
Gastroenteritis * 1  3/248 (1.21%)  1/251 (0.40%) 
Infected dermal cyst * 1  1/248 (0.40%)  1/251 (0.40%) 
Appendicitis perforated * 1  1/248 (0.40%)  0/251 (0.00%) 
Atypical pneumonia * 1  1/248 (0.40%)  0/251 (0.00%) 
Bronchiolitis * 1  1/248 (0.40%)  0/251 (0.00%) 
Cellulitis * 1  2/248 (0.81%)  0/251 (0.00%) 
Clostridium difficile infection * 1  1/248 (0.40%)  0/251 (0.00%) 
Dengue fever * 1  0/248 (0.00%)  1/251 (0.40%) 
Enterocolitis infectious * 1  1/248 (0.40%)  0/251 (0.00%) 
Infection * 1  1/248 (0.40%)  0/251 (0.00%) 
Lobar pneumonia * 1  1/248 (0.40%)  0/251 (0.00%) 
Pharyngitis * 1  1/248 (0.40%)  0/251 (0.00%) 
Salmonella bacteraemia * 1  1/248 (0.40%)  0/251 (0.00%) 
Salpingo-oophoritis * 1  1/248 (0.40%)  0/251 (0.00%) 
Tooth abscess * 1  1/248 (0.40%)  0/251 (0.00%) 
Tooth infection * 1  1/248 (0.40%)  0/251 (0.00%) 
Arthritis bacterial * 1  1/248 (0.40%)  0/251 (0.00%) 
Cellulitis of male external genital organ * 1  1/248 (0.40%)  0/251 (0.00%) 
Dermatitis infected * 1  1/248 (0.40%)  0/251 (0.00%) 
Eczema infected * 1  1/248 (0.40%)  0/251 (0.00%) 
Gastroenteritis rotavirus * 1  0/248 (0.00%)  1/251 (0.40%) 
Gastrointestinal infection * 1  1/248 (0.40%)  0/251 (0.00%) 
Hepatitis A * 1  1/248 (0.40%)  0/251 (0.00%) 
Hepatitis B * 1  0/248 (0.00%)  1/251 (0.40%) 
Hepatitis E * 1  0/248 (0.00%)  1/251 (0.40%) 
Infectious colitis * 1  1/248 (0.40%)  0/251 (0.00%) 
Intrauterine infection * 1  0/248 (0.00%)  1/251 (0.40%) 
Malaria * 1  1/248 (0.40%)  0/251 (0.00%) 
Parotitis * 1  0/248 (0.00%)  1/251 (0.40%) 
Pharyngotonsillitis * 1  1/248 (0.40%)  0/251 (0.00%) 
Salmonellosis * 1  1/248 (0.40%)  0/251 (0.00%) 
Subcutaneous abscess * 1  0/248 (0.00%)  1/251 (0.40%) 
Urinary tract infection * 1  1/248 (0.40%)  0/251 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  0/248 (0.00%)  1/251 (0.40%) 
Concussion * 1  0/248 (0.00%)  1/251 (0.40%) 
Contusion * 1  1/248 (0.40%)  1/251 (0.40%) 
Exposure via father * 1  0/248 (0.00%)  1/251 (0.40%) 
Facial bones fracture * 1  1/248 (0.40%)  0/251 (0.00%) 
Gun shot wound * 1  0/248 (0.00%)  1/251 (0.40%) 
Laceration * 1  0/248 (0.00%)  1/251 (0.40%) 
Limb injury * 1  0/248 (0.00%)  1/251 (0.40%) 
Lower limb fracture * 1  1/248 (0.40%)  0/251 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  7/248 (2.82%)  0/251 (0.00%) 
Aspartate aminotransferase increased * 1  4/248 (1.61%)  0/251 (0.00%) 
Blood creatinine increased * 1  1/248 (0.40%)  0/251 (0.00%) 
Blood lactate dehydrogenase increased * 1  1/248 (0.40%)  0/251 (0.00%) 
Platelet count decreased * 1  1/248 (0.40%)  0/251 (0.00%) 
Blood creatine phosphokinase increased * 1  0/248 (0.00%)  1/251 (0.40%) 
Hepatitis C antibody positive * 1  0/248 (0.00%)  1/251 (0.40%) 
Lipase increased * 1  1/248 (0.40%)  0/251 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/248 (0.81%)  0/251 (0.00%) 
Hypokalaemia * 1  0/248 (0.00%)  1/251 (0.40%) 
Cell death * 1  0/248 (0.00%)  1/251 (0.40%) 
Fluid overload * 1  0/248 (0.00%)  1/251 (0.40%) 
Gout * 1  1/248 (0.40%)  0/251 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain * 1  0/248 (0.00%)  1/251 (0.40%) 
Myalgia * 1  0/248 (0.00%)  1/251 (0.40%) 
Back pain * 1  2/248 (0.81%)  2/251 (0.80%) 
Intervertebral disc disorder * 1  2/248 (0.81%)  0/251 (0.00%) 
Osteoarthritis * 1  0/248 (0.00%)  1/251 (0.40%) 
Pain in extremity * 1  0/248 (0.00%)  1/251 (0.40%) 
Spinal osteoarthritis * 1  1/248 (0.40%)  0/251 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Blast cell crisis * 1  1/248 (0.40%)  1/251 (0.40%) 
Chronic myeloid leukaemia transformation * 1  0/248 (0.00%)  1/251 (0.40%) 
Malignant melanoma * 1  1/248 (0.40%)  0/251 (0.00%) 
Metastases to bone * 1  0/248 (0.00%)  1/251 (0.40%) 
Adenocarcinoma gastric * 1  2/248 (0.81%)  0/251 (0.00%) 
Basal cell carcinoma * 1  1/248 (0.40%)  1/251 (0.40%) 
Bladder squamous cell carcinoma stage unspecified * 1  1/248 (0.40%)  0/251 (0.00%) 
Blast crisis in myelogenous leukaemia * 1  0/248 (0.00%)  1/251 (0.40%) 
Chronic lymphocytic leukaemia * 1  0/248 (0.00%)  1/251 (0.40%) 
Invasive ductal breast carcinoma * 1  1/248 (0.40%)  0/251 (0.00%) 
Rectal cancer recurrent * 1  0/248 (0.00%)  1/251 (0.40%) 
Renal cancer * 1  0/248 (0.00%)  1/251 (0.40%) 
Nervous system disorders     
Cerebral haemorrhage * 1  1/248 (0.40%)  0/251 (0.00%) 
Cerebrovascular accident * 1  0/248 (0.00%)  1/251 (0.40%) 
Carotid artery aneurysm * 1  0/248 (0.00%)  1/251 (0.40%) 
Carpal tunnel syndrome * 1  1/248 (0.40%)  0/251 (0.00%) 
Headache * 1  1/248 (0.40%)  0/251 (0.00%) 
Lumbar radiculopathy * 1  0/248 (0.00%)  1/251 (0.40%) 
Central nervous system haemorrhage * 1  0/248 (0.00%)  1/251 (0.40%) 
Dizziness * 1  1/248 (0.40%)  0/251 (0.00%) 
Seizure * 1  2/248 (0.81%)  0/251 (0.00%) 
Syncope * 1  1/248 (0.40%)  1/251 (0.40%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 1  2/248 (0.81%)  1/251 (0.40%) 
Psychiatric disorders     
Depression * 1  1/248 (0.40%)  1/251 (0.40%) 
Dissociative disorder * 1  1/248 (0.40%)  0/251 (0.00%) 
Anxiety * 1  1/248 (0.40%)  0/251 (0.00%) 
Disorientation * 1  1/248 (0.40%)  0/251 (0.00%) 
Hallucination * 1  1/248 (0.40%)  0/251 (0.00%) 
Renal and urinary disorders     
Urinary retention * 1  0/248 (0.00%)  1/251 (0.40%) 
Renal failure * 1  1/248 (0.40%)  0/251 (0.00%) 
Acute kidney injury * 1  5/248 (2.02%)  0/251 (0.00%) 
Calculus bladder * 1  0/248 (0.00%)  1/251 (0.40%) 
Calculus urinary * 1  1/248 (0.40%)  0/251 (0.00%) 
Haematuria * 1  1/248 (0.40%)  0/251 (0.00%) 
Nephrotic syndrome * 1  0/248 (0.00%)  1/251 (0.40%) 
Reproductive system and breast disorders     
Menstruation irregular * 1  0/248 (0.00%)  1/251 (0.40%) 
Metrorrhagia * 1  1/248 (0.40%)  0/251 (0.00%) 
Ovarian cyst * 1  1/248 (0.40%)  0/251 (0.00%) 
Vaginal haemorrhage * 1  0/248 (0.00%)  1/251 (0.40%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease * 1  2/248 (0.81%)  0/251 (0.00%) 
Pleural effusion * 1  11/248 (4.44%)  0/251 (0.00%) 
Acute pulmonary oedema * 1  2/248 (0.81%)  0/251 (0.00%) 
Bronchiectasis * 1  1/248 (0.40%)  0/251 (0.00%) 
Bronchitis chronic * 1  1/248 (0.40%)  0/251 (0.00%) 
Chronic obstructive pulmonary disease * 1  1/248 (0.40%)  0/251 (0.00%) 
Lung disorder * 1  1/248 (0.40%)  0/251 (0.00%) 
Pleuritic pain * 1  1/248 (0.40%)  0/251 (0.00%) 
Vocal cord polyp * 1  1/248 (0.40%)  0/251 (0.00%) 
Pneumonitis * 1  1/248 (0.40%)  0/251 (0.00%) 
Pulmonary hypertension * 1  2/248 (0.81%)  0/251 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/248 (0.40%)  0/251 (0.00%) 
Rash maculo-papular * 1  1/248 (0.40%)  0/251 (0.00%) 
Social circumstances     
Pregnancy of partner * 1  1/248 (0.40%)  0/251 (0.00%) 
Surgical and medical procedures     
Cyst removal * 1  1/248 (0.40%)  0/251 (0.00%) 
Vascular disorders     
Haemorrhage * 1  1/248 (0.40%)  0/251 (0.00%) 
Hypertension * 1  1/248 (0.40%)  0/251 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bosutinib Imatinib
Affected / at Risk (%) Affected / at Risk (%)
Total   235/248 (94.76%)   238/251 (94.82%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  70/248 (28.23%)  72/251 (28.69%) 
Anaemia * 1  63/248 (25.40%)  58/251 (23.11%) 
Neutropenia * 1  35/248 (14.11%)  78/251 (31.08%) 
Leukopenia * 1  24/248 (9.68%)  57/251 (22.71%) 
Lymphopenia * 1  8/248 (3.23%)  16/251 (6.37%) 
Eye disorders     
Eyelid oedema * 1  3/248 (1.21%)  20/251 (7.97%) 
Periorbital oedema * 1  4/248 (1.61%)  38/251 (15.14%) 
Gastrointestinal disorders     
Diarrhoea * 1  174/248 (70.16%)  69/251 (27.49%) 
Nausea * 1  87/248 (35.08%)  93/251 (37.05%) 
Vomiting * 1  86/248 (34.68%)  42/251 (16.73%) 
Abdominal pain upper * 1  38/248 (15.32%)  21/251 (8.37%) 
Abdominal pain * 1  34/248 (13.71%)  19/251 (7.57%) 
Dyspepsia * 1  22/248 (8.87%)  17/251 (6.77%) 
Abdominal distension * 1  8/248 (3.23%)  13/251 (5.18%) 
Constipation * 1  13/248 (5.24%)  12/251 (4.78%) 
Toothache * 1  13/248 (5.24%)  4/251 (1.59%) 
General disorders     
Fatigue * 1  38/248 (15.32%)  33/251 (13.15%) 
Pyrexia * 1  44/248 (17.74%)  34/251 (13.55%) 
Oedema peripheral * 1  14/248 (5.65%)  32/251 (12.75%) 
Asthenia * 1  23/248 (9.27%)  23/251 (9.16%) 
Oedema * 1  14/248 (5.65%)  16/251 (6.37%) 
Face oedema * 1  5/248 (2.02%)  15/251 (5.98%) 
Infections and infestations     
Upper respiratory tract infection * 1  33/248 (13.31%)  24/251 (9.56%) 
Nasopharyngitis * 1  26/248 (10.48%)  28/251 (11.16%) 
Bronchitis * 1  14/248 (5.65%)  14/251 (5.58%) 
Influenza * 1  23/248 (9.27%)  11/251 (4.38%) 
Pharyngitis * 1  13/248 (5.24%)  4/251 (1.59%) 
Investigations     
Alanine aminotransferase increased * 1  85/248 (34.27%)  27/251 (10.76%) 
Aspartate aminotransferase increased * 1  70/248 (28.23%)  28/251 (11.16%) 
Lipase increased * 1  47/248 (18.95%)  29/251 (11.55%) 
Blood creatine phosphokinase increased * 1  23/248 (9.27%)  58/251 (23.11%) 
Blood alkaline phosphatase increased * 1  18/248 (7.26%)  11/251 (4.38%) 
Blood creatinine increased * 1  14/248 (5.65%)  16/251 (6.37%) 
Weight increased * 1  6/248 (2.42%)  24/251 (9.56%) 
Gamma-glutamyltransferase increased * 1  16/248 (6.45%)  5/251 (1.99%) 
Amylase increased * 1  27/248 (10.89%)  16/251 (6.37%) 
Haemoglobin decreased * 1  5/248 (2.02%)  14/251 (5.58%) 
Weight decreased * 1  16/248 (6.45%)  3/251 (1.20%) 
Metabolism and nutrition disorders     
Hypophosphataemia * 1  26/248 (10.48%)  55/251 (21.91%) 
Decreased appetite * 1  22/248 (8.87%)  8/251 (3.19%) 
Hypokalaemia * 1  8/248 (3.23%)  22/251 (8.76%) 
Hyperglycaemia * 1  6/248 (2.42%)  16/251 (6.37%) 
Hypocalcaemia * 1  11/248 (4.44%)  17/251 (6.77%) 
Hypomagnesaemia * 1  5/248 (2.02%)  16/251 (6.37%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  13/248 (5.24%)  61/251 (24.30%) 
Arthralgia * 1  24/248 (9.68%)  34/251 (13.55%) 
Bone pain * 1  10/248 (4.03%)  25/251 (9.96%) 
Myalgia * 1  16/248 (6.45%)  31/251 (12.35%) 
Pain in extremity * 1  18/248 (7.26%)  24/251 (9.56%) 
Back pain * 1  20/248 (8.06%)  21/251 (8.37%) 
Nervous system disorders     
Headache * 1  33/248 (13.31%)  34/251 (13.55%) 
Dizziness * 1  23/248 (9.27%)  28/251 (11.16%) 
Psychiatric disorders     
Insomnia * 1  10/248 (4.03%)  13/251 (5.18%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  30/248 (12.10%)  31/251 (12.35%) 
Dyspnoea * 1  24/248 (9.68%)  9/251 (3.59%) 
Oropharyngeal pain * 1  12/248 (4.84%)  15/251 (5.98%) 
Pleural effusion * 1  14/248 (5.65%)  1/251 (0.40%) 
Skin and subcutaneous tissue disorders     
Rash * 1  64/248 (25.81%)  49/251 (19.52%) 
Pruritus * 1  16/248 (6.45%)  16/251 (6.37%) 
Alopecia * 1  13/248 (5.24%)  9/251 (3.59%) 
Vascular disorders     
Hypertension * 1  20/248 (8.06%)  14/251 (5.58%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00574873     History of Changes
Other Study ID Numbers: 3160A4-3000
B1871008 ( Other Identifier: Alias Study Number )
2007-003780-50 ( EudraCT Number )
First Submitted: December 13, 2007
First Posted: December 17, 2007
Results First Submitted: October 4, 2012
Results First Posted: November 5, 2012
Last Update Posted: January 8, 2019