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This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mavacamten (MYK-461) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mavacamten | Drug | mavacamten capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that:
| From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks) |
| Number of Participants Who Had Cardiovascular Death | Number of participants who had died due to cardiovascular reasons. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants Who Experienced Sudden Death | Number of participants who experienced sudden death | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants Who Were Hospitalized for Cardiovascular Reasons. | Number of participants who were hospitalized for cardiovascular reasons. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50% |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0003 | Scottsdale | Arizona | 85259 | United States | ||
| Local Institution - 0001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38591260 | Derived | Masri A, Lester SJ, Stendahl JC, Hegde SM, Sehnert AJ, Balaratnam G, Shah A, Fox S, Wang A. Long-Term Safety and Efficacy of Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy: Interim Results of the PIONEER-OLE Study. J Am Heart Assoc. 2024 Apr 16;13(8):e030607. doi: 10.1161/JAHA.123.030607. Epub 2024 Apr 9. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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13 Participants enrolled and treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Mavacamtem | Mavacamtem |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2021 |
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Number of participants with heart failure due to systolic dysfunction, defined as asymptomatic LVEF < 50% |
| From first dose to end of study, (approximately 260 weeks) |
| Number of Participants With LVEF < 50% as Measured by Echocardiography. | Number of participants with LVEF < 50% as measured by echocardiography. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants Who Were Experienced Myocardial Infarction | Number of participants who experienced myocardial infarction. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants With Ventricular Arrhythmias. | Types of Ventricular Arrhythmias measured in this endpoint will be: Ventricular Tachycardia Ventricular Fibrilation Ventricular Flutter | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants Who Experienced Syncope | Number of participants who experienced syncope. Syncope will be defined as participants who experienced dizziness or orthostatic hypotension. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants Who Experienced Seizures | Number of participants who were experienced seizures. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants Who Were Experienced Strokes | Number of participants who were experienced strokes. | From first dose to end of study, (approximately 260 weeks) |
| Number of Participants With a Change in QT and QTcF Intervals. | Number of participants with a change in QTcF intervals. QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR/1000) RR = Respiration rate QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec | From first dose to end of study, (approximately 260 weeks) |
| Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time | Number of participants with changes of Post-exercise left ventricular outflow tract (LVOT) gradient over time | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 |
| Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time | Resting left ventricular outflow tract (LVOT) gradient over time | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 |
| Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time | Post Valsalva left ventricular outflow tract (LVOT) gradient over time | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 |
| Participants With >= 1 NYHA Function Class Improvement | Participants with >= 1 NYHA function class improvement. The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
| Mean Change From Baseline in the Overall KCCQ PRO Score. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered 23-item questionnaire questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Overall KCCQ Pro score is the average of all the domains, symptom frequency and symptom burden scores, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status. | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
| Mean Change From Baseline in Serum NT-proBNP. | Mean change from baseline in Serum N-terminal pro B-type natriuretic peptide levels. | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
| Number of Participants Who Received Septal Reduction Therapy | Number of participants who received septal reduction therapy | 252 weeks |
| Plasma Concentration of Mavacamen Overtime | Plasma concentration of Mavacamen overtime | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
| New Haven |
| Connecticut |
| 06520-8017 |
| United States |
| Local Institution - 0004 | Durham | North Carolina | 27710 | United States |
| Local Institution - 0002 | Portland | Oregon | 97239 | United States |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mavacamtem | Mavacamtem |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events | AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that:
| All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks) |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Had Cardiovascular Death | Number of participants who had died due to cardiovascular reasons. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Sudden Death | Number of participants who experienced sudden death | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Were Hospitalized for Cardiovascular Reasons. | Number of participants who were hospitalized for cardiovascular reasons. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50% | Number of participants with heart failure due to systolic dysfunction, defined as asymptomatic LVEF < 50% | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With LVEF < 50% as Measured by Echocardiography. | Number of participants with LVEF < 50% as measured by echocardiography. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Were Experienced Myocardial Infarction | Number of participants who experienced myocardial infarction. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Ventricular Arrhythmias. | Types of Ventricular Arrhythmias measured in this endpoint will be: Ventricular Tachycardia Ventricular Fibrilation Ventricular Flutter | All treated participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Syncope | Number of participants who experienced syncope. Syncope will be defined as participants who experienced dizziness or orthostatic hypotension. | All treated participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced Seizures | Number of participants who were experienced seizures. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Were Experienced Strokes | Number of participants who were experienced strokes. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Change in QT and QTcF Intervals. | Number of participants with a change in QTcF intervals. QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR/1000) RR = Respiration rate QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec | All treated participants | Posted | Count of Participants | Participants | From first dose to end of study, (approximately 260 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time | Number of participants with changes of Post-exercise left ventricular outflow tract (LVOT) gradient over time | Safety Analysis Population | Posted | Count of Participants | Participants | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time | Resting left ventricular outflow tract (LVOT) gradient over time | Safety Analysis Population | Posted | Count of Participants | Participants | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time | Post Valsalva left ventricular outflow tract (LVOT) gradient over time | Safety Analysis Population | Posted | Count of Participants | Participants | At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Participants With >= 1 NYHA Function Class Improvement | Participants with >= 1 NYHA function class improvement. The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Safety Analysis Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
|
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| Primary | Mean Change From Baseline in the Overall KCCQ PRO Score. | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered 23-item questionnaire questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Overall KCCQ Pro score is the average of all the domains, symptom frequency and symptom burden scores, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status. | Safety Analysis Population | Posted | Mean | Standard Deviation | Scores on a Scale | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
|
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| Primary | Mean Change From Baseline in Serum NT-proBNP. | Mean change from baseline in Serum N-terminal pro B-type natriuretic peptide levels. | Safety Analysis Population | Posted | Mean | Standard Deviation | ng/L | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
|
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| Primary | Number of Participants Who Received Septal Reduction Therapy | Number of participants who received septal reduction therapy | All Treated Participants | Posted | Count of Participants | Participants | 252 weeks |
|
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| Primary | Plasma Concentration of Mavacamen Overtime | Plasma concentration of Mavacamen overtime | PK Analysis Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252 |
|
|
Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mavacamten | Mavacamtem | 0 | 13 | 5 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mitral valve incompetence | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Cardiac flutter | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
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| Thyroid mass | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
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| Eyelid ptosis | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Biliary obstruction | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Prostate infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Post procedural constipation | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Post procedural hypotension | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Cortisol decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Drug level increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Troponin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Vitamin D decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Insulin resistance | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| Cluster headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness exertional | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Facial spasm | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Ophthalmic migraine | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | 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 | 1-855-907-3286 | Clinical.Trials@bms.com |
| Nov 5, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605992 | MYK-461 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Denominators |
|---|
| Categories |
|---|
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| Categories |
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| Title |
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| Denominators |
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| Categories |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
| Ventricular Tachycardia |
| |||||
| Ventricular Fibrilation |
| |||||
| Ventricular Flutter |
| |||||
| Torsades De Pointe |
|
| Title | Denominators | Categories |
|---|
| Dizziness |
| |||||
| Orthostatic Hypotension |
|
| Categories |
|---|
|
| Denominators |
|---|
| Categories |
|---|
|
|
| Title | Denominators | Categories |
|---|
| Baseline |
|
| ||||||||
| Week 4 |
|
| ||||||||
| Week 48 |
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| ||||||||
| Week 72 |
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| ||||||||
| Week 156 |
|
| ||||||||
| Week 204 |
|
| ||||||||
| Week 252 |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Baseline |
|
| ||||||||
| Week 4 |
|
| ||||||||
| Week 48 |
|
| ||||||||
| Week 72 |
|
| ||||||||
| Week 156 |
|
| ||||||||
| Week 204 |
|
| ||||||||
| Week 252 |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Baseline |
|
| ||||||||
| Week 4 |
|
| ||||||||
| Week 48 |
|
| ||||||||
| Week 72 |
|
| ||||||||
| Week 156 |
|
| ||||||||
| Week 204 |
|
| ||||||||
| Week 252 |
|
|
|
|
| Title | Denominators | Categories |
|---|
| Change from baseline at week 4 |
|
| ||||
| Change from baseline at week 8 |
|
| ||||
| Change from baseline at week 24 |
|
| ||||
| Change from baseline at week 48 |
|
| ||||
| Change from baseline at week 72 |
|
| ||||
| Change from baseline at week 96 |
|
| ||||
| Change from baseline at week 120 |
|
| ||||
| Change from baseline at week 144 |
|
| ||||
| Change from baseline at week 156 |
|
| ||||
| Change from baseline at week 180 |
|
| ||||
| Change from baseline at week 204 |
|
| ||||
| Change from baseline at week 228 |
|
| ||||
| Change from baseline at week 252 |
|
|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
| Week 4 |
|
| ||||
| Week 8 |
|
| ||||
| Week 24 |
|
| ||||
| Week 48 |
|
| ||||
| Week 72 |
|
| ||||
| Week 96 |
|
| ||||
| Week 120 |
|
| ||||
| Week 144 |
|
| ||||
| Week 156 |
|
| ||||
| Week 180 |
|
| ||||
| Week 204 |
|
| ||||
| Week 228 |
|
| ||||
| Week 252 |
|
|