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A Phase II Trial of Regadenoson in Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT01788631
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
Boston Children's Hospital
La Jolla Institute for Allergy & Immunology
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Children's Hospital Medical Center, Cincinnati
University of Illinois at Chicago
Medical College of Wisconsin
Duke University
Johns Hopkins University
Wayne State University
Baylor College of Medicine
UCSF Benioff Children's Hospital Oakland
Information provided by (Responsible Party):
David G. Nathan, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Sickle Cell Anemia
Interventions Drug: Regadenoson
Drug: Placebo
Enrollment 100
Recruitment Details Between July 2013 and November 2016, 4,940 hospital admissions were screened to enroll 100 study subjects. Patients were recruited at the time of sickle cell vaso-occlusive crises in outpatient clinics, emergency departments, and inpatient units.
Pre-assignment Details Prior to study arm randomization and assignment, patients were screened using the following testing methods: Confirmation of sickle cell genotype, complete blood count with differential, chemistry, coagulation testing (Including PTT, and INR), and pregnancy testing for female participants.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Period Title: Overall Study
Started 52 44
Randomized 53 47
Completed 49 43
Not Completed 3 1
Arm/Group Title Regadenoson Arm Placebo Arm Total
Hide Arm/Group Description

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Total of all reporting groups
Overall Number of Baseline Participants 53 47 100
Hide Baseline Analysis Population Description
All enrolled patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 53 participants 47 participants 100 participants
25
(10 to 54)
26
(13 to 56)
25
(10 to 56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 47 participants 100 participants
Female 22 24 46
Male 31 23 54
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 47 participants 100 participants
53 47 100
1.Primary Outcome
Title Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More
Hide Description To determine if infusional Regadenoson reduced iNKT cell activation among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo by 70% or greater.
Time Frame Baseline-End of study infusion over 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients with baseline and end of infusion blood samples.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Measure Type: Count of Participants
Unit of Measure: Participants
21
  42.9%
10
  23.3%
2.Secondary Outcome
Title Length of Hospital Stay
Hide Description To determine if regadenoson reduces length of hospital stay among individuals admitted with SCA and pain or ACS compared to placebo
Time Frame Hospital Presentation- Hospital Discharge, assessed up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had baseline and end of infusion blood samples.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Median (Full Range)
Unit of Measure: Days
3.96
(2.23 to 19.25)
3.99
(2.34 to 30.40)
3.Secondary Outcome
Title Number of Participants With an Improvement in Respiratory Symptoms
Hide Description To determine if regadenoson improved respiratory symptoms among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo. Patients were classified as having an improvement in respiratory symptoms if they experienced any of the following outcomes:(1) respiratory rate decreased by 25% from baseline or normalized (≤20 bpm) or (2) degree of hypoxia (SpO2) on room air increased by 10% from baseline or normalized (≥92%) or (3) thoracic pain improved by 3 points from baseline on a 10-point visual analog scale.
Time Frame Baseline-End of study infusion over 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had baseline and end of infusion blood samples.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Measure Type: Count of Participants
Unit of Measure: Participants
10
  20.4%
9
  20.9%
4.Secondary Outcome
Title Opioid Use
Hide Description To determine if regadenoson reduces opioid use among individuals with SCA and pain or ACS compared to placebo.
Time Frame Baseline-End of study infusion over 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had baseline and end of infusion blood samples.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Median (Full Range)
Unit of Measure: mg/kg/hr
0.03
(0.00 to 0.50)
0.04
(0.00 to 0.36)
5.Secondary Outcome
Title Level of Inflammatory Markers (A2A)
Hide Description To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.
Time Frame Baseline-End of study infusion over 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had baseline and end of infusion blood samples.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Median (Full Range)
Unit of Measure: A2A levels as percent of baseline
86.39
(35.3 to 316.67)
100.95
(17.44 to 404.66)
6.Secondary Outcome
Title Level of Inflammatory Markers (IL-4)
Hide Description To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.
Time Frame Baseline-End of study infusion over 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had baseline and end of infusion blood samples.
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Median (Full Range)
Unit of Measure: IL-4 levels as percent of baseline
85.89
(33.51 to 389.76)
100.91
(17.35 to 351.09)
7.Secondary Outcome
Title Level of Inflammatory Markers (IFN-gamma)
Hide Description To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.
Time Frame Baseline-End of study infusion over 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had baseline and end of treatment samples
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description:

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Overall Number of Participants Analyzed 49 43
Median (Full Range)
Unit of Measure: IFN-gamma levels as percent of baseline
97.38
(42.50 to 293.83)
105.66
(28.01 to 420.99)
Time Frame Adverse events were assessed from the time patients presented to the emergency department for their vaso-occlusive crisis through 30 days post- hospital discharge.
Adverse Event Reporting Description For this study, all adverse events Grade 3 and above were categorized as serious adverse events.
 
Arm/Group Title Regadenoson Arm Placebo Arm
Hide Arm/Group Description

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

All-Cause Mortality
Regadenoson Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/44 (0.00%) 
Hide Serious Adverse Events
Regadenoson Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   14/52 (26.92%)   16/44 (36.36%) 
Blood and lymphatic system disorders     
Anemia  1  2/52 (3.85%)  0/44 (0.00%) 
Cardiac disorders     
Chest pain - cardiac  1  1/52 (1.92%)  0/44 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/52 (1.92%)  0/44 (0.00%) 
Diarrhea  1  1/52 (1.92%)  0/44 (0.00%) 
Gastrointestinal disorders - Other, specify  1  0/52 (0.00%)  1/44 (2.27%) 
General disorders     
General disorders and administration site conditions - Other, specify  1  2/52 (3.85%)  0/44 (0.00%) 
Non-cardiac chest pain  1  1/52 (1.92%)  2/44 (4.55%) 
Pain  1  0/52 (0.00%)  3/44 (6.82%) 
Infections and infestations     
Tooth infection  1  1/52 (1.92%)  0/44 (0.00%) 
Investigations     
Blood bilirubin increased  1  0/52 (0.00%)  1/44 (2.27%) 
Hemoglobin increased  1  1/52 (1.92%)  0/44 (0.00%) 
Neutrophil count decreased  1  1/52 (1.92%)  0/44 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/52 (1.92%)  0/44 (0.00%) 
Avascular necrosis  1  0/52 (0.00%)  1/44 (2.27%) 
Back pain  1  4/52 (7.69%)  4/44 (9.09%) 
Chest wall pain  1  0/52 (0.00%)  1/44 (2.27%) 
Pain in extremity  1  7/52 (13.46%)  8/44 (18.18%) 
Nervous system disorders     
Headache  1  1/52 (1.92%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  0/52 (0.00%)  1/44 (2.27%) 
Pleuritic pain  1  0/52 (0.00%)  1/44 (2.27%) 
Pneumonitis  1  1/52 (1.92%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/52 (0.00%)  2/44 (4.55%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regadenoson Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   44/52 (84.62%)   35/44 (79.55%) 
Blood and lymphatic system disorders     
Anemia  1  4/52 (7.69%)  5/44 (11.36%) 
Blood and lymphatic system disorders - Other, specify  1  2/52 (3.85%)  0/44 (0.00%) 
Hemolysis  1  0/52 (0.00%)  1/44 (2.27%) 
Cardiac disorders     
Atrioventricular block first degree  1  0/52 (0.00%)  1/44 (2.27%) 
Cardiac disorders - Other, specify  1  1/52 (1.92%)  2/44 (4.55%) 
Palpitations  1  0/52 (0.00%)  2/44 (4.55%) 
Sinus tachycardia  1  3/52 (5.77%)  3/44 (6.82%) 
Ventricular tachycardia  1  1/52 (1.92%)  0/44 (0.00%) 
Eye disorders     
Blurred vision  1  0/52 (0.00%)  1/44 (2.27%) 
Dry eye  1  0/52 (0.00%)  1/44 (2.27%) 
Eye disorders - Other, specify  1  1/52 (1.92%)  0/44 (0.00%) 
Photophobia  1  0/52 (0.00%)  1/44 (2.27%) 
Scleral disorder  1  2/52 (3.85%)  1/44 (2.27%) 
Gastrointestinal disorders     
Abdominal pain  1  1/52 (1.92%)  4/44 (9.09%) 
Constipation  1  7/52 (13.46%)  6/44 (13.64%) 
Diarrhea  1  4/52 (7.69%)  3/44 (6.82%) 
Ileus  1  0/52 (0.00%)  1/44 (2.27%) 
Nausea  1  5/52 (9.62%)  11/44 (25.00%) 
Stomach pain  1  1/52 (1.92%)  0/44 (0.00%) 
Vomiting  1  5/52 (9.62%)  11/44 (25.00%) 
General disorders     
Chills  1  0/52 (0.00%)  1/44 (2.27%) 
Edema limbs  1  2/52 (3.85%)  0/44 (0.00%) 
Fatigue  1  3/52 (5.77%)  0/44 (0.00%) 
Fever  1  7/52 (13.46%)  6/44 (13.64%) 
General disorders and administration site conditions - Other, specify  1  0/52 (0.00%)  1/44 (2.27%) 
Infusion related reaction  1  1/52 (1.92%)  0/44 (0.00%) 
Infusion site extravasation  1  1/52 (1.92%)  0/44 (0.00%) 
Localized edema  1  1/52 (1.92%)  0/44 (0.00%) 
Non-cardiac chest pain  1  0/52 (0.00%)  4/44 (9.09%) 
Pain  1  3/52 (5.77%)  2/44 (4.55%) 
Infections and infestations     
Infections and infestations - Other, specify  1  1/52 (1.92%)  2/44 (4.55%) 
Upper respiratory infection  1  1/52 (1.92%)  1/44 (2.27%) 
Urinary tract infection  1  2/52 (3.85%)  0/44 (0.00%) 
Vaginal infection  1  1/52 (1.92%)  0/44 (0.00%) 
Investigations     
Platelet count decreased  1  1/52 (1.92%)  0/44 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  2/52 (3.85%)  1/44 (2.27%) 
Hypokalemia  1  0/52 (0.00%)  1/44 (2.27%) 
Hypomagnesemia  1  2/52 (3.85%)  1/44 (2.27%) 
Hyponatremia  1  0/52 (0.00%)  1/44 (2.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/52 (1.92%)  1/44 (2.27%) 
Arthritis  1  1/52 (1.92%)  0/44 (0.00%) 
Back pain  1  5/52 (9.62%)  4/44 (9.09%) 
Chest wall pain  1  1/52 (1.92%)  2/44 (4.55%) 
Generalized muscle weakness  1  1/52 (1.92%)  0/44 (0.00%) 
Myalgia  1  0/52 (0.00%)  1/44 (2.27%) 
Pain in extremity  1  10/52 (19.23%)  7/44 (15.91%) 
Nervous system disorders     
Dizziness  1  3/52 (5.77%)  0/44 (0.00%) 
Headache  1  6/52 (11.54%)  10/44 (22.73%) 
Lethargy  1  2/52 (3.85%)  0/44 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/52 (0.00%)  1/44 (2.27%) 
Delirium  1  0/52 (0.00%)  1/44 (2.27%) 
Hallucinations  1  1/52 (1.92%)  0/44 (0.00%) 
Renal and urinary disorders     
Hematuria  1  0/52 (0.00%)  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  0/52 (0.00%)  1/44 (2.27%) 
Allergic rhinitis  1  1/52 (1.92%)  2/44 (4.55%) 
Atelectasis  1  1/52 (1.92%)  0/44 (0.00%) 
Cough  1  3/52 (5.77%)  2/44 (4.55%) 
Dyspnea  1  1/52 (1.92%)  0/44 (0.00%) 
Epistaxis  1  0/52 (0.00%)  1/44 (2.27%) 
Hoarseness  1  1/52 (1.92%)  0/44 (0.00%) 
Hypoxia  1  2/52 (3.85%)  3/44 (6.82%) 
Nasal congestion  1  3/52 (5.77%)  1/44 (2.27%) 
Pleural effusion  1  1/52 (1.92%)  0/44 (0.00%) 
Productive cough  1  1/52 (1.92%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  5/52 (9.62%)  3/44 (6.82%) 
Retinoic acid syndrome  1  1/52 (1.92%)  0/44 (0.00%) 
Sore throat  1  1/52 (1.92%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders     
Bullous dermatitis  1  1/52 (1.92%)  0/44 (0.00%) 
Dry skin  1  1/52 (1.92%)  0/44 (0.00%) 
Pruritus  1  8/52 (15.38%)  4/44 (9.09%) 
Rash maculo-papular  1  1/52 (1.92%)  0/44 (0.00%) 
Skin and subcutaneous tissue disorders - Other, specify  1  1/52 (1.92%)  1/44 (2.27%) 
Skin/subcutaneous tissue disorders; Other, specify  1  1/52 (1.92%)  0/44 (0.00%) 
Skin ulceration  1  1/52 (1.92%)  0/44 (0.00%) 
Vascular disorders     
Flushing  1  0/52 (0.00%)  1/44 (2.27%) 
Hypertension  1  2/52 (3.85%)  2/44 (4.55%) 
Thromboembolic event  1  0/52 (0.00%)  1/44 (2.27%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David G. Nathan
Organization: Dana-Farber Cancer Institute
Phone: 61746322155
EMail: David_Nathan@dfci.harvard.edu
Layout table for additonal information
Responsible Party: David G. Nathan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01788631    
Other Study ID Numbers: 13-005
1P50HL110790-01 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2013
First Posted: February 11, 2013
Results First Submitted: September 19, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018