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The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Azacitidine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Azacitidine | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Survival (RFS) | The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment. | Approximately 17.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from randomization to death from any cause and will be calculated using the randomization date and date of death, or date of last follow-up for censored participants. All participants will be followed until dropout, death, or study termination. Participants who dropout or are alive at study termination will have their OS times censored at the time of last contact, as appropriate. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria 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 - 0011 | Huntsville | Alabama | 35801 | United States | ||
| Local Institution - 0017 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
19 Participants randomized and treated
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 | CC-486, 200mg taken for the first 14 days of each 28-day treatment cycle |
| FG001 | Treatment 2 | Placebo, 200mg taken for the first 14 days of each 28-day treatment cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
Not provided
Not provided
Not provided
| 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 | Jun 27, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Specified dose of specified days |
|
| Approximately 17.7 months |
| Time to Relapse From CR or CRi | The interval from the date of randomization to the date of documented relapse after CR or CRi, as defined according to the IWG AML response criteria. Time to relapse will be analyzed using a competing risk analysis where death without documented relapse is treated as a competing risk for relapse from CR/CRi. Similar censoring rules as in primary analysis of RFS will be applied. | Approximately 17.7 months |
| Time to Discontinuation | The interval from the date of randomization to the date of discontinuation from IP. Subjects who are ongoing in treatment at the time of study closure will be censored at the date of last visit. | Approximately 17.7 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Approximately 17.7 months |
| Number of Participants With Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination | Approximately 17.7 months |
| Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs include the following: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, temperature and weight. | Approximately 17.7 months |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Examinations | Approximately 17.7 months |
| Number of Participants Who Received Concomitant Medication | Concomitant medications are defined as non-study medications that are started after the date of randomization but before the end of the study treatment period or started on or before the date of randomization but ended or remain ongoing during the study treatment period. | Approximately 17.7 months |
| Mean Change From Baseline in Facit-Fatigue Scale | The FACIT-Fatigue Scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during usual daily activities over the past week. The level of fatigue is measured on a five-point Likert scale (0 = not at all fatigued to 4 = very much fatigued). It has scores that range from 0 to 52, with higher scores indicating less fatigue. Quality of life (QoL)scores on these FACIT scales significantly decline as patient performance status worsens. | From C1D1 to C12D1 (approximately 336 days) |
| Mean Change From Baseline in EQ-5D-5L | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. The lower the score the better. | From C1D1 to C12D1 (approximately 336 days) |
| Pharmacokinetic Evaluation: CMax | Cmax is defined as maximum plasma concentration of the drug. | on C1D1 (after first dose on day 1) |
| Pharmacokinetic Evaluation: Tmax | Tmax is defined is the time to maximum plasma concentration | on C1D1 (after first dose on day 1) |
| Pharmacokinetic Evaluation: AUC(0-T) | Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration. | on C1D1 (after first dose on day 1) |
| Pharmacokinetic Evaluation: AUC(INF) | on C1D1 (after first dose on day 1) |
| Pharmacokinetic Evaluation: T-Half | the time required for the amount or concentration of a drug to decrease by one-half | on C1D1 (after first dose on day 1) |
| Pharmacokinetic Evaluation: CLT/F(INF) | the volume of plasma from which a substance is completely removed per unit time. | on C1D1 (after first dose on day 1) |
| Pharmacokinetic Evaluation: Vz/F | the amount of drug in the body to the concentration of drug measured in a biological fluid | on C1D1 (after first dose on day 1) |
| Nagoya |
| Aichi-ken |
| 453-8511 |
| Japan |
| Local Institution - 0023 | Nagoya | Aichi-ken | 4668560 | Japan |
| Local Institution - 0009 | Toyoake | Aichi-ken | 470-1192 | Japan |
| Local Institution - 0022 | Aomori | Aomori | 0308553 | Japan |
| Local Institution - 0005 | Kamogawa | Chiba | 2968602 | Japan |
| Local Institution - 0003 | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution - 0010 | Matsuyama | Ehime | 7900826 | Japan |
| Local Institution - 0020 | Yoshida Gun | Fukui | 9101193 | Japan |
| Local Institution - 0016 | Fukuoka | Fukuoka | 810-8539 | Japan |
| Local Institution - 0014 | Ōgaki | Gifu | 503-8502 | Japan |
| Local Institution - 0001 | Maebashi | Gunma | 3710821 | Japan |
| Local Institution - 0004 | Sapporo | Hokkaido | 0640804 | Japan |
| Local Institution - 0019 | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Local Institution - 0012 | Isehara | Kanagawa | 2591193 | Japan |
| Local Institution - 0006 | Sagamihara-shi | Kanagawa | 2520375 | Japan |
| Local Institution - 0013 | Yokohama | Kanagawa | 236-0004 | Japan |
| Local Institution - 0015 | Sendai | Miyagi | 9808574 | Japan |
| Local Institution - 0026 | Osaka | Osaka | 5300012 | Japan |
| Local Institution - 0021 | Ōsaka-sayama | Osaka | 5898511 | Japan |
| Local Institution - 0031 | Shimotsuke | Tochigi | 329-0498 | Japan |
| Local Institution - 0032 | Bunkyo Ku | Tokyo | 1138677 | Japan |
| Local Institution - 0002 | Shinagawa | Tokyo | 141-8625 | Japan |
| Local Institution - 0030 | Shinjuku-ku | Tokyo | 1600023 | Japan |
| Local Institution - 0029 | Sumida Ku | Tokyo | 1308575 | Japan |
| Local Institution - 0018 | Fukuoka | 810-8563 | Japan |
| Local Institution - 0027 | Fukuoka | 8120033 | Japan |
| Local Institution - 0008 | Nagasaki | 8528511 | Japan |
| Local Institution - 0025 | Okayama | 7000914 | Japan |
| Local Institution - 0028 | Saitama | 330-8503 | Japan |
| Local Institution - 0007 | Yamagata | 990-9585 | Japan |
| COMPLETED | = Ongoing Treatment |
|
| NOT COMPLETED |
|
|
| Follow Up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 | CC-486, 200mg taken for the first 14 days of each 28-day treatment cycle |
| BG001 | Treatment 2 | Placebo, 200mg taken for the first 14 days of each 28-day treatment cycle |
| 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 | 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 | Recurrence Free Survival (RFS) | The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment. | All Treated Participants | Posted | Median | Full Range | Months | Approximately 17.7 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The time from randomization to death from any cause and will be calculated using the randomization date and date of death, or date of last follow-up for censored participants. All participants will be followed until dropout, death, or study termination. Participants who dropout or are alive at study termination will have their OS times censored at the time of last contact, as appropriate. | All Treated Participants | Posted | Median | Full Range | Months | Approximately 17.7 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Relapse From CR or CRi | The interval from the date of randomization to the date of documented relapse after CR or CRi, as defined according to the IWG AML response criteria. Time to relapse will be analyzed using a competing risk analysis where death without documented relapse is treated as a competing risk for relapse from CR/CRi. Similar censoring rules as in primary analysis of RFS will be applied. | All Treated Participants | Posted | Median | Full Range | Months | Approximately 17.7 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Discontinuation | The interval from the date of randomization to the date of discontinuation from IP. Subjects who are ongoing in treatment at the time of study closure will be censored at the date of last visit. | All Treated Participants | Posted | Median | Full Range | Months | Approximately 17.7 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | All Treated Participants | Posted | Count of Participants | Participants | Approximately 17.7 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination | All Treated Participants | Posted | Count of Participants | Participants | Approximately 17.7 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs include the following: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, temperature and weight. | All Treated Participants | Posted | Count of Participants | Participants | Approximately 17.7 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Examinations | All Treated Participants | Posted | Count of Participants | Participants | Approximately 17.7 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Received Concomitant Medication | Concomitant medications are defined as non-study medications that are started after the date of randomization but before the end of the study treatment period or started on or before the date of randomization but ended or remain ongoing during the study treatment period. | All Treated Participants | Posted | Count of Participants | Participants | Approximately 17.7 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Facit-Fatigue Scale | The FACIT-Fatigue Scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during usual daily activities over the past week. The level of fatigue is measured on a five-point Likert scale (0 = not at all fatigued to 4 = very much fatigued). It has scores that range from 0 to 52, with higher scores indicating less fatigue. Quality of life (QoL)scores on these FACIT scales significantly decline as patient performance status worsens. | All Treated Participants | Posted | Mean | Standard Deviation | Score on a Scale | From C1D1 to C12D1 (approximately 336 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in EQ-5D-5L | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. The lower the score the better. | All Treated Participants | Posted | Mean | Standard Deviation | Score on a Scale | From C1D1 to C12D1 (approximately 336 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: CMax | Cmax is defined as maximum plasma concentration of the drug. | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | on C1D1 (after first dose on day 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: Tmax | Tmax is defined is the time to maximum plasma concentration | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Median | Full Range | hours (h) | on C1D1 (after first dose on day 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: AUC(0-T) | Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration. | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | on C1D1 (after first dose on day 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: AUC(INF) | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | on C1D1 (after first dose on day 1) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: T-Half | the time required for the amount or concentration of a drug to decrease by one-half | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Median | Full Range | hours (h) | on C1D1 (after first dose on day 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: CLT/F(INF) | the volume of plasma from which a substance is completely removed per unit time. | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | on C1D1 (after first dose on day 1) |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Evaluation: Vz/F | the amount of drug in the body to the concentration of drug measured in a biological fluid | Due to limited data collection only 1 participant had data collected on C1D1. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | on C1D1 (after first dose on day 1) |
|
|
Adverse Events and Serious Adverse Events: (From first dose to last dose + 28 days): Approximately 18.7 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 | Treatment 1 | CC-486, 200mg taken for the first 14 days of each 28-day treatment cycle | 1 | 12 | 4 | 12 | 12 | 12 |
| EG001 | Treatment 2 | Placebo, 200mg taken for the first 14 days of each 28-day treatment cycle | 2 | 7 | 2 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoglobulinaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Trichoglossia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Chillblains | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour marker abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | 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 |
| Jan 22, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C000709231 | cc-486 |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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