Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001421-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
| PPD Development, LP | INDUSTRY |
| Molecular MD | UNKNOWN |
| European Organisation for Research and Treatment of Cancer - EORTC |
Not provided
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The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.
Primary Purpose: Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib | Experimental | Dasatinib 50, 80, 100, 140, 180 mg tablets by mouth, once daily, up to 60 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Molecular Response (MMR) Rate | Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts < 0.1% on the International Scale [IS]) at 12 months after Dasatinib discontinuation without restarting Dasatinib | At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) Rate | Event-free survival (EFS) rate is defined as the percentage of surviving participants with no loss of Major Molecular Response (MMR) at the specified timepoints after dasatinib discontinuation. MMR is defined as BCR-ABL transcripts < 0.1% IS. Loss of MMR is defined per the European LeukemiaNet (ELN) definition of progression. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC): Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes ≥ 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood ≥ 20%,or platelets < 100 x 10^9 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM ≥ 30%, or extramedullary blast cell involvement (with exception of spleen and liver) The date of progression is defined as the date any of the above criteria is first met. Participants who have not progressed will be censored on the date of last examination. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
Signed Written Informed Consent
Target Population
Age and Reproductive Status
Exclusion Criteria:
Target Disease Exceptions
Medical History and Concurrent Diseases
Prior or concurrent malignancy, except the following:
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy in case re-initiation of dasatinib is needed.
Uncontrolled or significant cardiovascular disease
Subjects with prior history of pericardial effusion or pleural effusion that required thoracentesis are excluded. Subjects with prior history of pericardial or pleural effusion that was clinically manageable and a maintained CMR for ≥ 1 year on a stable dose of dasatinib are allowed.
History of significant bleeding disorder unrelated to CML
Allergies and Adverse Drug Reaction
a. Subjects with known hypersensitivity to excipients of Dasatinib tablets
Sex and Reproductive Status
Other Exclusion Criteria
Additional Criteria for Patients Eligible to Restart Dasatinib
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0006 | Duarte | California | 91010 | United States | ||
| Local Institution - 0029 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37246588 | Derived | Shah NP, Garcia-Gutierrez V, Jimenez-Velasco A, Larson SM, Saussele S, Rea D, Mahon FX, Levy MY, Gomez-Casares MT, Mauro MJ, Sy O, Martin-Regueira P, Lipton JH. Treatment-free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: Final 5-year analysis of DASFREE. Br J Haematol. 2023 Sep;202(5):942-952. doi: 10.1111/bjh.18883. Epub 2023 May 29. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total | Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2017 | Sep 20, 2018 |
| NETWORK |
| MultiPharma | UNKNOWN |
| Steering Committee | UNKNOWN |
Not provided
Not provided
Not provided
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| From 12 months after Dasatinib treatment discontinuation to every 12 months thereafter (up to approximately 60 months) |
| Relapse-Free Survival (RFS) Rate | RFS is the percentage of participants who did not relapse at the specified timepoints. Participants who did not relapse were censored on the date of their last molecular assessment. Relapse is defined as any of the following events while on study: the loss of Major Molecular Response (MMR), loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. MMR is defined as BCR-ABL transcripts < 0.1% IS. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample based on evaluation of at least 20 metaphases. CCyR is defined as 0% Ph+ cells in metaphase in BM. CHR is obtained when all the following criteria are met in peripheral blood (PB) sampling: white blood cell ≤10,000/mm3; Platelets < 450,000/mm3; PB basophils <5%; No blasts or promyelocytes in PB; <5% myelocytes plus metamyelocytes in PB; No extramedullary involvement (including no hepatomegaly or splenomegaly). | From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months) |
| Progression Free Survival (PFS) Rate | Progression free survival (PFS) is defined as the percentage of participants who experienced death (due to any cause) or accelerated phase, or blast crisis. Participants who neither progress nor die will be censored on the date of their last molecular assessment. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes >= 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood >= 20%,or platelets < 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM >= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver) | From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months) |
| Number of Participants Who Experience Intermittent Loss of Complete Molecular Response (CMR) (MR4.5) But no Loss of Major Molecular Response (MMR) | The number of participants who did not lose major molecular response (MMR) 60 months after discontinuing study treatment who were in MR4.5 at the time of discontinuation and lost MR4.5. Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (Q-PCR). MMR is defined as BCR-ABL transcripts < 0.1% Internal Standard (IS). CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response. | 60 months after last dose |
| Number of Participants Who Did Not Experience Loss of Complete Molecular Response (CMR) (MR4.5) and Major Molecular Response (MMR) | Assessment of BCR-ABL kinetics in patients who are in CMR (MR4.5) or less when transcript levels are still measurable. CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response. | From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months) |
| Time to Transformation to Accelerated Phase/Blast Crisis (AP/BC) | Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date. | From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months) |
| Overall Survival (OS) | Overall survival (OS) is defined as the time from dasatinib treatment discontinuation to the date of death (due to any cause) or last known alive date. Participants who do not die will be censored on their last known alive date. | From 12 months after Dasatinib treatment discontinuation to the date of death or last known alive date (up to approximately 82 months) |
| Progression Free Survival | Progression-free survival (PFS) is defined as the time from treatment discontinuation to the date of progression or death (due to any cause), whichever occurs first. Participants who neither progress nor die will be censored on the date of their last molecular assessment. | From treatment discontinuation to the date of progression or death due to any cause, whichever occurs first (up to 82 months) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Local Institution - 0001 | San Franisco | California | 94143 | United States |
| Local Institution - 0013 | Chicago | Illinois | 60611 | United States |
| Local Institution - 0024 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0028 | New York | New York | 10032 | United States |
| Local Institution - 0011 | Dallas | Texas | 75246 | United States |
| Local Institution - 0023 | Houston | Texas | 77030-4000 | United States |
| Local Institution - 0005 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0012 | Paris | 75475 | France |
| Local Institution - 0003 | Pessac | 33604 | France |
| Local Institution - 0030 | Pierre-Bénite | 69495 | France |
| Local Institution - 0002 | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution - 0019 | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Local Institution - 0026 | Aachen | D-52074 | Germany |
| Local Institution - 0020 | Berlin | 13353 | Germany |
| Local Institution - 0021 | Mannheim | 68167 | Germany |
| Local Institution - 0022 | Ulm | 89081 | Germany |
| Local Institution - 0025 | Catania | 95123 | Italy |
| Local Institution - 0017 | Florence | 50134 | Italy |
| Local Institution - 0027 | Naples | 80131 | Italy |
| Local Institution - 0015 | Orbassano | 10143 | Italy |
| Local Institution - 0018 | Roma | 00144 | Italy |
| Local Institution - 0016 | Rome | 00161 | Italy |
| Local Institution - 0014 | Oviedo | Principality of Asturias | 33011 | Spain |
| Local Institution - 0009 | Las Palmas de Gran Canaria | 35010 | Spain |
| Local Institution - 0010 | Madrid | 28034 | Spain |
| Local Institution - 0008 | Málaga | 29010 | Spain |
| BMS Clinical Trial Patient Recruiting | View source |
| Restart Treatment | Restarted treatment due to failure to maintain MMR levels of BCL-ABL |
|
| Discontinued Study Treatment After Restart |
|
| COMPLETED | Completed study |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total | Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Major Molecular Response (MMR) Rate | Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts < 0.1% on the International Scale [IS]) at 12 months after Dasatinib discontinuation without restarting Dasatinib | All enrolled participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018) |
|
|
| |||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) Rate | Event-free survival (EFS) rate is defined as the percentage of surviving participants with no loss of Major Molecular Response (MMR) at the specified timepoints after dasatinib discontinuation. MMR is defined as BCR-ABL transcripts < 0.1% IS. Loss of MMR is defined per the European LeukemiaNet (ELN) definition of progression. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC): Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes ≥ 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood ≥ 20%,or platelets < 100 x 10^9 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM ≥ 30%, or extramedullary blast cell involvement (with exception of spleen and liver) The date of progression is defined as the date any of the above criteria is first met. Participants who have not progressed will be censored on the date of last examination. | All enrolled participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From 12 months after Dasatinib treatment discontinuation to every 12 months thereafter (up to approximately 60 months) |
| |||||||||||||||||||||||||||
| Secondary | Relapse-Free Survival (RFS) Rate | RFS is the percentage of participants who did not relapse at the specified timepoints. Participants who did not relapse were censored on the date of their last molecular assessment. Relapse is defined as any of the following events while on study: the loss of Major Molecular Response (MMR), loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. MMR is defined as BCR-ABL transcripts < 0.1% IS. Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample based on evaluation of at least 20 metaphases. CCyR is defined as 0% Ph+ cells in metaphase in BM. CHR is obtained when all the following criteria are met in peripheral blood (PB) sampling: white blood cell ≤10,000/mm3; Platelets < 450,000/mm3; PB basophils <5%; No blasts or promyelocytes in PB; <5% myelocytes plus metamyelocytes in PB; No extramedullary involvement (including no hepatomegaly or splenomegaly). | All enrolled participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months) |
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Rate | Progression free survival (PFS) is defined as the percentage of participants who experienced death (due to any cause) or accelerated phase, or blast crisis. Participants who neither progress nor die will be censored on the date of their last molecular assessment. Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes >= 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood >= 20%,or platelets < 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM >= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver) | All enrolled participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From 12 months after Dasatinib treatment discontinuation to every 6 months thereafter (up to approximately 60 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Intermittent Loss of Complete Molecular Response (CMR) (MR4.5) But no Loss of Major Molecular Response (MMR) | The number of participants who did not lose major molecular response (MMR) 60 months after discontinuing study treatment who were in MR4.5 at the time of discontinuation and lost MR4.5. Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (Q-PCR). MMR is defined as BCR-ABL transcripts < 0.1% Internal Standard (IS). CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response. | Participants with no loss of major molecular response (MMR) | Posted | Count of Participants | Participants | 60 months after last dose |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Did Not Experience Loss of Complete Molecular Response (CMR) (MR4.5) and Major Molecular Response (MMR) | Assessment of BCR-ABL kinetics in patients who are in CMR (MR4.5) or less when transcript levels are still measurable. CMR (MR4.5) defined as ≤ 0.0032% (IS) or ≥ 4.5 log reduction of BCR-ABL transcript levels molecular response. | All enrolled participants | Posted | Count of Participants | Participants | From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Transformation to Accelerated Phase/Blast Crisis (AP/BC) | Time to Transformation to AP/BC is defined as the rate at which participants experienced transformation to accelerated phase/blast crisis (AP/BC) since discontinuation. Participants who did not develop to AP, late phase, or BC phase were censored on their last molecular measurement date. | All enrolled participants | Posted | Median | 95% Confidence Interval | Months | From 12 months after Dasatinib treatment discontinuation to 5 years after the first visit of the last enrolled participant (up to approximately 82 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) is defined as the time from dasatinib treatment discontinuation to the date of death (due to any cause) or last known alive date. Participants who do not die will be censored on their last known alive date. | All enrolled participants | Posted | Median | 95% Confidence Interval | Months | From 12 months after Dasatinib treatment discontinuation to the date of death or last known alive date (up to approximately 82 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression-free survival (PFS) is defined as the time from treatment discontinuation to the date of progression or death (due to any cause), whichever occurs first. Participants who neither progress nor die will be censored on the date of their last molecular assessment. | All enrolled participants | Posted | Median | 95% Confidence Interval | Months | From treatment discontinuation to the date of progression or death due to any cause, whichever occurs first (up to 82 months) |
|
|
Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 85 months)
The number at Risk for All-Cause Mortality represents all enrolled Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication during re-treatment.
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 | Total | Prior to study entry participants received dasatinib as treatment for a minimum of 2 years. Upon enrollment dasatinib will be discontinued. Dasatinib will be restarted if major molecular response is lost during the off-treatment period at the dose level received before study entry. The participant will remain on treatment for the duration of the study. | 1 | 84 | 8 | 47 | 42 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| External ear cellulitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Polychondritis | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2018 | Oct 31, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Asian |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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