Trial Outcomes & Findings for Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures (NCT NCT01898208)

Results Overview

Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

743 participants

Primary outcome timeframe

Approximately 4 days after enrollment

Results posted on

2016-03-15

Participant Flow

Subjects were recruited at the Mayo Clinic in Rochester, Minnesota from August 2013 to March 2014.

Participant milestones

Participant milestones
Measure	Control Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Overall Study STARTED	247	247	249
Overall Study COMPLETED	207	198	212
Overall Study NOT COMPLETED	40	49	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Overall Study Positive blood culture	17	23	15
Overall Study Death/comfort care within 24 hours	10	9	8
Overall Study Negative Gram Stain	6	9	6
Overall Study Non-Blood Specimens in Bottles	3	5	4
Overall Study System/Technical Error	1	2	3
Overall Study Lost to Follow-up	3	1	1

Baseline Characteristics

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.	Total n=617 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 19.32 • n=5 Participants	61.4 years STANDARD_DEVIATION 21.22 • n=7 Participants	61.2 years STANDARD_DEVIATION 20.08 • n=5 Participants	61.4 years STANDARD_DEVIATION 20.17 • n=4 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	82 Participants n=7 Participants	85 Participants n=5 Participants	232 Participants n=4 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	116 Participants n=7 Participants	127 Participants n=5 Participants	385 Participants n=4 Participants
Region of Enrollment United States	207 participants n=5 Participants	198 participants n=7 Participants	212 participants n=5 Participants	617 participants n=4 Participants

PRIMARY outcome

Timeframe: Approximately 4 days after enrollment

Population: Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)

Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Duration of Antimicrobial Therapy (Hours) Vancomycin (van), all subjects (n=132, 101, 124)	44 hours Interval 22.0 to 72.0	42 hours Interval 21.0 to 93.0	42 hours Interval 19.0 to 90.0
Duration of Antimicrobial Therapy (Hours) Van, organisms not requiring van (n=56, 56,57)	8.2 hours Interval 0.0 to 26.0	0 hours Interval 0.0 to 16.0	0 hours Interval 0.0 to 3.0
Duration of Antimicrobial Therapy (Hours) Van-susceptible enterococci (n=8, 8, 16)	20 hours Interval 1.0 to 59.0	70 hours Interval 48.0 to 88.0	82 hours Interval 40.0 to 96.0
Duration of Antimicrobial Therapy (Hours) Van, Methicillin-susceptible S.aureus(n=13,13,16)	23 hours Interval 20.0 to 53.0	11 hours Interval 0.0 to 26.0	8 hours Interval 0.0 to 44.0
Duration of Antimicrobial Therapy (Hours) Nafcillin, oxacillin, or cefazolin (n=20, 16, 14)	42 hours Interval 24.0 to 57.0	71 hours Interval 51.0 to 79.0	85 hours Interval 42.0 to 92.0
Duration of Antimicrobial Therapy (Hours) Piperacillin-tazobactam (n=77, 65, 72)	56 hours Interval 39.0 to 82.0	44 hours Interval 27.0 to 74.0	45 hours Interval 19.0 to 78.0
Duration of Antimicrobial Therapy (Hours) Cefepime (n=62, 52, 67	55 hours Interval 28.0 to 96.0	71 hours Interval 43.0 to 96.0	58 hours Interval 32.0 to 96.0

SECONDARY outcome

Timeframe: Approximately 14 days after positive blood culture

Population: Not all subjects were not on active therapy at enrollment, and also subjects with contaminated blood cultures were excluded. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship): (n=45, 41, 37)

From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Time From Positive Gram Stain to First Active Antibiotic	11 hours Interval 2.0 to 51.0	6 hours Interval 2.0 to 31.0	4 hours Interval 2.0 to 20.0

SECONDARY outcome

Timeframe: Positive Gram stain, 96 hours after enrollment

Population: Not all subjects experienced de-escalation or escalation of their antibiotics. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship).

De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=247 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=249 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics Time to first approp. de-escalation(n=121,112,111)	34 hours Interval 21.0 to 55.0	38 hours Interval 22.0 to 66.0	21 hours Interval 7.0 to 37.0
Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics Time to first appropriate escalation (40,38,44)	24 hours Interval 3.0 to 67.0	6 hours Interval 2.0 to 36.0	5 hours Interval 2.0 to 22.0

SECONDARY outcome

Timeframe: Within 14 days after positive blood culture

Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours	75 Percentage of blood cultures	89 Percentage of blood cultures	92 Percentage of blood cultures

SECONDARY outcome

Timeframe: Approximately 14 days after positive blood culture

Population: The number of subjects analyzed per arm differs from the number of subjects who completed the study because this outcome measure includes only the subset of subjects who had organisms represented on the rapid multiplex PCR (rmPCR) panel.

Outcome measures

Outcome measures
Measure	Control n=169 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=147 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=165 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Time to Pathogen Identification	22.3 hours Interval 17.0 to 28.0	1.3 hours Interval 0.9 to 1.6	1.3 hours Interval 0.9 to 1.6

SECONDARY outcome

Timeframe: 3 Days after enrollment

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment	147 participants	131 participants	146 participants

SECONDARY outcome

Timeframe: Participants were followed for the duration of hospital stay, approximately 15 days

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Length of Entire Hospitalization (Days)	8 days Interval 5.0 to 15.0	8 days Interval 5.0 to 15.0	8 days Interval 5.0 to 16.0

SECONDARY outcome

Timeframe: 30 days after positive blood culture

If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
All-cause and Attributable Mortality All-cause mortality	22 participants	20 participants	18 participants
All-cause and Attributable Mortality Attributable mortality	7 participants	7 participants	2 participants

SECONDARY outcome

Timeframe: Approximately 14 days after positive blood culture

This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events	3 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: Approximately within 72 hours of positive blood culture

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment	49.8 percentage of participants	49 percentage of participants	45.3 percentage of participants

SECONDARY outcome

Timeframe: Approximately 7 days after positive blood culture and for duration of entire hospitalization

Population: The number of subjects analyzed per arm is different than the number of subjects who completed the study because outpatients and a few subjects without final billing data available were excluded.

Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.

Outcome measures

Outcome measures
Measure	Control n=191 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=171 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=182 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject Overall Hospitalization Costs	65,450 dollars Standard Deviation 128,686	66,887 dollars Standard Deviation 117,832	68,729 dollars Standard Deviation 134,215
Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject Laboratory Test Cost	5,377 dollars Standard Deviation 10,115	5,680 dollars Standard Deviation 8,872	5,743 dollars Standard Deviation 9,809
Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject Antimicrobials Costs	2,194 dollars Standard Deviation 4,175	1,932 dollars Standard Deviation 3,175	1,741 dollars Standard Deviation 2,748

OTHER_PRE_SPECIFIED outcome

Timeframe: within 14 days of positive blood culture until ICU discharge

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Length of Intensive Care Unit Stay	3 days Interval 2.0 to 4.0	2 days Interval 1.0 to 5.0	3 days Interval 2.0 to 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 30 days after positive blood culture

Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.

Outcome measures

Outcome measures
Measure	Control n=207 Participants Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 Participants Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 Participants Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment	7.2 percentage of participants	8.1 percentage of participants	9.9 percentage of participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

FilmArray Test

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

FilmArray Plus Antimicrobial Stewardship

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=207 participants at risk Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.	FilmArray Test n=198 participants at risk Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.	FilmArray Plus Antimicrobial Stewardship n=212 participants at risk Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Immune system disorders Myelosuppression	0.00% 0/207 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/198 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.47% 1/212 • Number of events 1 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.
Hepatobiliary disorders Hepatitis	0.48% 1/207 • Number of events 1 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/198 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/212 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.
Renal and urinary disorders Renal insufficiency	0.48% 1/207 • Number of events 1 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/198 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/212 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.
Skin and subcutaneous tissue disorders Rash	0.48% 1/207 • Number of events 1 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	1.0% 2/198 • Number of events 2 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/212 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.
Nervous system disorders Seizures	0.00% 0/207 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.51% 1/198 • Number of events 1 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/212 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.
Cardiac disorders Prolonged QTc interval	0.00% 0/207 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.00% 0/198 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.	0.47% 1/212 • Number of events 1 All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.

Additional Information

Ritu Banerjee, M.D., Ph.D.

Mayo Clinic

Phone: 507-284-6904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place