Trial Outcomes & Findings for Randomized Investigation of Chest Pain Diagnostic Strategies (NCT NCT01035047)
NCT ID: NCT01035047
Last Updated: 2018-09-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Index Hospitalization through 90 days
Results posted on
2018-09-10
Participant Flow
Recruitment occurred in the Emergency Department (ED) at Wake Forest Baptist Medical Center from March 2010 to June 2011.
No participants were excluded from the trial prior to treatment assignment.
Participant milestones
| Measure |
CDU-CMR Protocol
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
COMPLETED
|
52
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Investigation of Chest Pain Diagnostic Strategies
Baseline characteristics by cohort
| Measure |
CDU-CMR Protocol
n=52 Participants
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 Participants
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
59 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Index Hospitalization through 90 daysPopulation: Data from all participants was used in the primary outcome analysis.
Outcome measures
| Measure |
CDU-CMR Protocol
n=52 Participants
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 Participants
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.
|
7 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Duration of Index Hospitalization, an average of 1-2 daysPopulation: Data from all participants was used in outcome analysis.
Outcome measures
| Measure |
CDU-CMR Protocol
n=52 Participants
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 Participants
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Length of Stay
|
21.1 hours
Interval 14.8 to 25.2
|
26.3 hours
Interval 22.7 to 44.8
|
SECONDARY outcome
Timeframe: Index Hospitalization discharge through 90 daysPopulation: Data from all participants was used in outcome analysis.
Outcome measures
| Measure |
CDU-CMR Protocol
n=52 Participants
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 Participants
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Acute Coronary Syndrome
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Index Hospitalization through 90 daysPopulation: Data from all participants was used for outcome analysis.
Outcome measures
| Measure |
CDU-CMR Protocol
n=52 Participants
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 Participants
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Mortality
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Index Hospitalization through 90 daysPopulation: Data from all participants was used for outcome analysis
Outcome measures
| Measure |
CDU-CMR Protocol
n=52 Participants
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 Participants
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Stress Testing-related Adverse Event
|
1 participants
|
0 participants
|
Adverse Events
CDU-CMR Protocol
Serious events: 14 serious events
Other events: 18 other events
Deaths: 0 deaths
Inpatient Care
Serious events: 15 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDU-CMR Protocol
n=52 participants at risk
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 participants at risk
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Cardiac disorders
Readmission for chest pain.
|
15.4%
8/52 • Number of events 15 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
17.0%
9/53 • Number of events 16 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Admission for syncope.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
Admission for dyspnea.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Pulseless Electrical Activity (PEA) Arrest
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Psychiatric disorders
Admission for overdose with suicidal ideation and worsening depression
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Surgical and medical procedures
Admission for laparoscopic radical prostatectomy
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Gastrointestinal disorders
Admission for abdominal pain, nausea, vomiting, and diarrhea.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Gastrointestinal disorders
Admission for abdominal pain.
|
1.9%
1/52 • Number of events 2 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
Admission for motor vehicle collision (MVC)
|
3.8%
2/52 • Number of events 2 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Underwent cardiac magnetic resonance imaging with evolving myocardial infarction
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Admission for atrial fibrillation.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Admission for palpitations and wide-complex tachycardia.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Admission for palpitations and atrial flutter with rapid ventricular rate.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Surgical and medical procedures
Admission for celiac arteriogram and stenting.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
Admission for shortness of breath, dysphagia, and chest pain.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
Admission for shortness of breath.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
Developed cerebral vascular accident (CVA) after dobutamine stress echocardiogram
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
Admission for pneumothorax after lung biopsy.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung biopsy positive for small cell undifferentiated carcinoma
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Admission for chemotherapy and radiation therapy
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
Admission for cough, chest pain, and pain with swallowing
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
Admission for cough and shortness of breath
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Blood and lymphatic system disorders
Admission for angioedema
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
Admission for dizziness
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
Admission for lower extremity pain and suspected septic hip
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Endocrine disorders
Admission for severe lactic acidosis secondary to diabetic ketoacidosis (DKA)
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Psychiatric disorders
Involuntary admission for psychiatric illness
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 2 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
Admission for seizure, altered consciousness, and facial fractures.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Admission for left arm numbness and chest pressure.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Surgical and medical procedures
Admission for symptomatic cholelithiasis and laparoscopic cholecystectomy.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
Admission for dizziness and presyncopal episodes
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Acute coronary syndrome after discharge within 90 days of index.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
5.7%
3/53 • Number of events 3 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
Other adverse events
| Measure |
CDU-CMR Protocol
n=52 participants at risk
Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
|
Inpatient Care
n=53 participants at risk
This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
|
|---|---|---|
|
Gastrointestinal disorders
ED visit for abdominal pain, constipation, and chest pain.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
ED visit for syncopal episode.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
ED visit for drainage from navel and facial numbness
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
ED visit for chest pain.
|
5.8%
3/52 • Number of events 3 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
5.7%
3/53 • Number of events 3 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Gastrointestinal disorders
ED visit for abdominal pain.
|
7.7%
4/52 • Number of events 4 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
3.8%
2/53 • Number of events 3 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Surgical and medical procedures
Negative exercise stress echocardiogram performed
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Renal and urinary disorders
ED visit for urinary frequency
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Renal and urinary disorders
ED visit for urinary frequency, hyperglycemia, and polydypsia
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for back pain and rib pain
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for back pain and hip pain
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Endocrine disorders
ED visit for abnormal glucose, diabetes, and hypertension
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
General disorders
ED visit for high blood pressure
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
Early termination of cardiac MRI due to concern for extensive coronary artery disease
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Gastrointestinal disorders
ED visit for lower abdominal pain and rectal bleeding
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Metabolism and nutrition disorders
ED visit for near syncope and mild dehydration
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
ED visit for palpitations
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Social circumstances
ED visit for intoxication
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Infections and infestations
ED visit for deep facial abscess.
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for left knee injury
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Cardiac disorders
ED visit for chest pain and intoxication
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Nervous system disorders
ED visit for headache
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
ED visit for dyspnea and generalized weakness
|
1.9%
1/52 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
0.00%
0/53 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for upper extremity pain
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Gastrointestinal disorders
ED visit for abdominal pain, vomiting, and diarrhea
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Infections and infestations
ED visit for bartholin's gland cyst.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for 5th metatarsal fracture and abrasion of the right knee
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for knee pain and chest pain.
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for back pain
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Investigations
Left against medical advice (AMA) from the ED during index hospitalization
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Gastrointestinal disorders
ED visit for vomiting
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Respiratory, thoracic and mediastinal disorders
ED visit for dyspnea
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for injury to nose and face
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Vascular disorders
ED visit for weakness and numbness
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for motor vehicle collision (MVC)
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Musculoskeletal and connective tissue disorders
ED visit for lower extremity pain and trouble walking
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
|
Psychiatric disorders
ED visit for depression
|
0.00%
0/52 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
1.9%
1/53 • Number of events 1 • 1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place