Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006181-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
| PPD Development, LP | INDUSTRY |
| Molecular MD | UNKNOWN |
| MultiPharma |
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Imatinib (≥400 mg) | Active Comparator | Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months |
|
| Arm 2: Dasatinib (100 mg) | Active Comparator | Dasatinib 100 mg tablet by mouth QD up to 60 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug |
|
| |
| Dasatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment | Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals. P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks). | At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Major Molecular Response (MMR) | Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0004 | Anaheim | California | 92801 | United States | ||
| Local Institution - 0006 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32265500 | Derived | Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
260 participants treated
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Imatinib (≥400 mg) | Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. |
| FG001 | Arm 2: Dasatinib (100 mg) | Dasatinib 100 mg tablet by mouth QD up to 60 months |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Mar 9, 2018 | Nov 8, 2018 |
Not provided
| UNKNOWN |
| Q2 Solutions | INDUSTRY |
| Donald E. Morisky | UNKNOWN |
| MD Anderson Symptom Inventory (MDASI-CML) | UNKNOWN |
| OBiS, Inc | UNKNOWN |
| Steering Committee | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| From randomization to study completion. Approximately 115 months |
| Time to Molecular Response (MR)^4.5 | Time to Molecular Response (MR)^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease <= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with >= 32,000 ABL transcripts. | From randomization to study completion. Approximately 115 months |
| Progression Free Survival (PFS) | PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored. Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment. Accelerated phase of CML:
Blast phase of CML
| From randomization to study completion. Approximately 115 months |
| Overall Survival (OS) | OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive. | From randomization to study completion. Approximately 115 months |
| Fontana |
| California |
| 92335 |
| United States |
| University Of Southern California University Hospital | Los Angeles | California | 90033 | United States |
| Local Institution - 0110 | Roseville | California | 95661 | United States |
| Local Institution - 0112 | San Jose | California | 95119 | United States |
| Local Institution - 0009 | Vallejo | California | 94589-2441 | United States |
| Local Institution - 0078 | Whittier | California | 90603 | United States |
| Local Institution - 0089 | Southington | Connecticut | 06489 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Northern Indiana Cancer Research Consortium | Crown Point | Indiana | 46307 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| University Of Iowa | Iowa City | Iowa | 52242 | United States |
| Local Institution - 0010 | Rochester | Minnesota | 55905 | United States |
| Local Institution - 0002 | Cincinnati | Ohio | 45242 | United States |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 0001 | Nashville | Tennessee | 37203-1625 | United States |
| Michael E Debakey VAMC | Houston | Texas | 77030 | United States |
| Institute of Oncology Hematology Biomedical Research | Laredo | Texas | 78041 | United States |
| Edwards Comprehensive Cancer Center | Huntington | West Virginia | 25701 | United States |
| Local Institution - 0005 | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution - 0093 | La Plata | Buenos Aires | 0 | Argentina |
| Local Institution - 0080 | Ramos MejÃa | Buenos Aires | 1221 | Argentina |
| Local Institution - 0049 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Local Institution - 0051 | Buenos Aires | 4102-4200 | Argentina |
| Local Institution - 0057 | Buenos Aires | C1114AAN | Argentina |
| Local Institution - 0100 | Corrientes | CP3400 | Argentina |
| Local Institution - 0026 | Innsbruck | Tyrol | 6020 | Austria |
| Local Institution - 0022 | Wels | Upper Austria | 4600 | Austria |
| Local Institution | Fürstenfeld | 8280 | Austria |
| Local Institution - 0043 | Graz | 8036 | Austria |
| Local Institution - 0024 | Linz | 4010 | Austria |
| Local Institution - 0023 | Vienna | 1090 Wien | Austria |
| Local Institution - 0065 | Bruges | B-8000 | Belgium |
| Local Institution - 0099 | Merksem | 2170 | Belgium |
| Local Institution | Yvoir | 5530 | Belgium |
| Local Institution - 0083 | Goiânia | Goiás | 74605-020 | Brazil |
| Local Institution | Curitiba | Paraná | 80060-900 | Brazil |
| Local Institution - 0063 | Campinas | São Paulo | 13083-970 | Brazil |
| Local Institution | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Local Institution - 0059 | São Paulo | São Paulo | 08270-070 | Brazil |
| Local Institution - 0062 | Rio de Janeiro | 20211-030 | Brazil |
| Local Institution - 0058 | Rio de Janeiro | 20231-050 | Brazil |
| Local Institution - 0111 | Rio de Janeiro | 20231-050 | Brazil |
| Local Institution - 0020 | Saint John | New Brunswick | E2L 4L2 | Canada |
| Local Institution - 0071 | Beijing | Beijing Municipality | 100044 | China |
| Local Institution - 0086 | Beijing | Beijing Municipality | 100071 | China |
| Local Institution - 0070 | Fuzhou | Fujian | 350001 | China |
| Local Institution - 0103 | Shenzhen | Guandong | 518035 | China |
| Local Institution - 0082 | Guangzhou | Guangdong | 510080 | China |
| Local Institution - 0074 | Guangzhou | Guangdong | 510515 | China |
| Local Institution - 0084 | Haerbin | Heilongjiang | 150010 | China |
| Local Institution - 0102 | Wuhan | Hubei | 430030 | China |
| Local Institution - 0073 | Nanjing | Jiangsu | 210029 | China |
| Local Institution - 0077 | Suzhou | Jiangsu | 215000 | China |
| Local Institution - 0094 | Shenyang | Liaoning | 110001 | China |
| Local Institution - 0088 | Xi'an | Shan3xi | 710000 | China |
| Local Institution - 0101 | Jinan | Shandong | 250012 | China |
| Local Institution - 0075 | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0069 | Tianjin | Tianjin Municipality | 300020 | China |
| Local Institution - 0072 | Hangzhou | 310003 | China |
| Local Institution - 0076 | Shanghai | 200025 | China |
| Local Institution - 0096 | Wuhan | 430030 | China |
| Local Institution - 0032 | Brno | Czech Republic | 625 00 | Czechia |
| Local Institution | Hradec Králové | 500 05 | Czechia |
| Local Institution | Olomouc | 775 20 | Czechia |
| Local Institution | Prague | 100 34 | Czechia |
| Local Institution - 0067 | Prague | 12808 | Czechia |
| Local Institution - 0045 | Le Chesnay | 78157 | France |
| Local Institution - 0041 | Lille | 59037 | France |
| Local Institution | Nantes | 44000 | France |
| Local Institution | Pierre-Bénite | 69495 | France |
| Local Institution - 0038 | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution | Budapest | 1083 | Hungary |
| Local Institution - 0104 | Szeged | 6725 | Hungary |
| Local Institution - 0106 | Brescia | Province Of Brescia | 25123 | Italy |
| Local Institution | Bari | 70124 | Italy |
| Local Institution | Bologna | 40138 | Italy |
| Local Institution | Catania | 95124 | Italy |
| Local Institution - 0027 | Florence | 50134 | Italy |
| Local Institution - 0046 | Monza | 20900 | Italy |
| Local Institution | Naples | 80131 | Italy |
| Local Institution - 0025 | Orbassano | 10143 | Italy |
| Local Institution - 0021 | Roma | 00144 | Italy |
| Local Institution - 0033 | Rome | 00161 | Italy |
| Local Institution - 0048 | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Local Institution - 0047 | Gdansk | 80-952 | Poland |
| Local Institution - 0098 | Katowice | 40-032 | Poland |
| Local Institution - 0064 | Warsaw | 02-776 | Poland |
| Local Institution - 0039 | Seoul | 06351 | South Korea |
| Local Institution - 0050 | Seoul | 137-701 | South Korea |
| Local Institution - 0040 | Seoul | 138-736 | South Korea |
| Local Institution - 0017 | A Couruna | 15706 | Spain |
| Local Institution - 0018 | L'Hospitalet Del Llobregat | 08908 | Spain |
| Local Institution - 0015 | Las Palmas de Gran Canaria | 35010 | Spain |
| Local Institution - 0012 | Madrid | 28007 | Spain |
| Local Institution - 0013 | Salamanca | 37007 | Spain |
| Local Institution - 0011 | Toledo | 45004 | Spain |
| Local Institution - 0055 | Muang | Chiang Mai | 50200 | Thailand |
| Local Institution | Bangkok | 10400 | Thailand |
| Local Institution - 0052 | Khon Kaen | 40002 | Thailand |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
|
| Crossed Over to Dasatinib |
|
| COMPLETED | Completed = Continuing in Treatment Period |
|
| NOT COMPLETED |
|
|
All Randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 2: Dasatinib (100 mg) | Dasatinib 100 mg tablet by mouth QD up to 60 months |
| BG001 | Arm 1: Imatinib (≥400 mg) | Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All Randomized Participants | Median | Full Range | years |
| ||||||||||||||
| Sex: Female, Male | All Randomized Participants | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | All Randomized Participants | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | All Randomized Participants | 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 | Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment | Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals. P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks). | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of Patients | At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Time to Major Molecular Response (MMR) | Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR. | All Randomized Participants | Posted | Median | 95% Confidence Interval | Months | From randomization to study completion. Approximately 115 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Molecular Response (MR)^4.5 | Time to Molecular Response (MR)^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease <= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with >= 32,000 ABL transcripts. | All Randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to study completion. Approximately 115 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored. Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment. Accelerated phase of CML:
Blast phase of CML
| All randomized participants with a progression event | Posted | Median | 95% Confidence Interval | Months | From randomization to study completion. Approximately 115 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive. | All randomized participants who died | Posted | Median | 95% Confidence Interval | Months | From randomization to study completion. Approximately 115 months |
|
|
From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized 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
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 | Arm 1: Imatinib | Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months. | 1 | 86 | 11 | 86 | 68 | 86 |
| EG001 | Arm 2: Dasatinib | Dasatinib 100 mg tablet by mouth QD up to 60 months | 11 | 174 | 48 | 171 | 159 | 171 |
| EG002 | Dasatinib After Crossover From Imatinib | Dasatinib 100 mg tablet by mouth QD | 4 | 46 | 8 | 46 | 42 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | 24.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | 24.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | 24.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Gingival cyst | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Salivary gland cyst | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Tuberculosis of central nervous system | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Paternal exposure timing unspecified | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Central nervous system leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia transformation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Glomerulonephritis chronic | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Nausea | 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 |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 24.1 | Systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Weight increased | Investigations | 24.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | 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 |
| |
| Muscle spasms | 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 |
| |
| 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 | Mar 9, 2018 | Nov 8, 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 |
|---|---|
| D000068877 | Imatinib Mesylate |
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|
|