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The purpose of this study was to determine clinical efficacy and safety of ruxolitinib (INCB018424), a small molecule Janus kinase 2 (JAK2)-inhibitor, in patients with refractory or relapsed multiple myeloma.
The protocol was originally designed as a Simon two stage but after it was determined that the initial 13 patients enrolled did not meet the definition of a 'responder' according to the International Uniform Response Criteria for multiple myeloma the protocol was amended to allow patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or had withdrawn consent to have 40 mg of dexamethasone added to their dose of ruxolitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib then Ruxolitinib + Dexamethasone | Experimental | Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib 25 mg | Drug | Ruxolitinib was supplied as 5 and 25 mg tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma | A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h). | Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma | Progressive Disease requires 1 or more of the following: Increase of ≥ 25% from baseline in: Serum M-component and/or (increase ≥ 0.5 g/dL). Urine M-component and/or (increase ≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be > l0 mg/dL. Bone marrow plasma cell percentage ≥ 10%. Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sundar Jagannath, MD | St. Vincent's Comprehensive Cancer Center, New York, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highland | California | 92346 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib Then Ruxolitinib + Dexamethasone | Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexamethasone 40 mg | Drug | Dexamethasone was obtained commercially by Investigators in tablet strengths of 20 or 40 mg. |
|
| Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months). |
| Boynton Beach |
| Florida |
| 33435 |
| United States |
| New York | New York | 10011 | United States |
| Received Ruxolitinib |
|
| Received Ruxolitinib + Dexamethasone |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib Then Ruxolitinib + Dexamethasone | Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Stage I: Relatively few cancer cells have spread throughout the body. Levels of red blood cells and calcium in the blood are normal. No bone tumors. M-protein in the blood or urine is very low. Possibly no symptoms of disease. Stage II: A moderate number of cancer cells have spread throughout the body. Stage III: A large number of cancer cells have spread throughout the body. There may be 1 or more of the following:
| Count of Participants | Participants |
| ||||||||||||||||||||||
| Stage of multiple myeloma at initial diagnosis | Number | 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 Responders According to the International Uniform Response Criteria for Multiple Myeloma | A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h). | Intent-to-treat population: All patients who were enrolled and took at least 1 dose of study medication. | Posted | Number | participants | Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months). |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma | Progressive Disease requires 1 or more of the following: Increase of ≥ 25% from baseline in: Serum M-component and/or (increase ≥ 0.5 g/dL). Urine M-component and/or (increase ≥ 200 mg/24 h). In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be > l0 mg/dL. Bone marrow plasma cell percentage ≥ 10%. Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia. | Intent-to-treat population. This outcome measure was not analyzed as no patients achieved a response. | Posted | Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months). |
|
Baseline to end of study
Safety population: All subjects who were enrolled and took 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 | Ruxolitinib | Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent. | 6 | 13 | 11 | 13 | ||
| EG001 | Ruxolitinib + Dexamethasone | Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit. | 6 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hilar lymphadenopathy | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Oral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Sputum culture positive | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Iron overload | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 855 463-3463 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| III |
|
| Unknown |
|
| Units | Counts |
|---|---|
| Participants |
|