Trial Outcomes & Findings for A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial (NCT NCT04786600)

NCT ID: NCT04786600

Last Updated: 2025-07-01

Results Overview

Determine the overall survival

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 580 days
• Results posted on: 2025-07-01

Participant Flow

Participant milestones

Measure	ctDNA Assay-guided Intervention Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.	Arm Not Assigned Subjects in this group were not assigned to an arm due to withdrawing from the study before they could be randomized.
Overall Study STARTED	1	3	2
Overall Study COMPLETED	1	3	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial

Baseline characteristics by cohort

Measure	ctDNA Assay-guided Intervention n=1 Participants Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention n=3 Participants Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.	Arm Not Assigned n=2 Participants Subjects in this group were not assigned to an arm due to going on study, but were not randomized to either protocol arm due to withdrawal from the study prior to randomization.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	47 years n=5 Participants	63 years n=7 Participants	55.5 years n=5 Participants	57.83 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: 580 days

Determine the overall survival

Outcome measures

Measure	ctDNA Assay-guided Intervention n=1 Participants Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention n=3 Participants Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
Overall Survival	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 year

Compare the proportion of subjects who receive ctDNA-guided treatment and scan-guided treatment that achieve each RECIST v1.1 response category (complete response, partial response, stable disease, and progressive disease) as their best response while on study treatment. Complete response is defined as the disappearance of all target lesions (any pathological lymph nodes must have reduction in short axis to <10 mm). Partial response is defined as least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of 1 or more new lesions is also considered progression. Stable disease is defined as either sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	ctDNA Assay-guided Intervention n=1 Participants Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention n=3 Participants Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
Best Overall Treatment Response Progressive disease	1 Participants	3 Participants
Best Overall Treatment Response Stable disease	0 Participants	0 Participants
Best Overall Treatment Response Partial response	0 Participants	0 Participants
Best Overall Treatment Response Complete response	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Determine progression-free survival

Outcome measures

Measure	ctDNA Assay-guided Intervention n=1 Participants Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention n=3 Participants Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
Progression-free Survival	0 Participants	0 Participants

Adverse Events

ctDNA Assay-guided Intervention

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Scan-guided Intervention

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Measure	ctDNA Assay-guided Intervention n=1 participants at risk Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention n=3 participants at risk Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
Infections and infestations Abdominal infection	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Vascular disorders Thromboembolic event	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.

Other adverse events

Measure	ctDNA Assay-guided Intervention n=1 participants at risk Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.	Scan-guided Intervention n=3 participants at risk Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Acidosis	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Alkaline phosphatase increased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Alanine aminotransferase increased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Blood and lymphatic system disorders Anemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	100.0% 3/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Anorexia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	100.0% 3/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Blood and lymphatic system disorders Decreased absolute basophils	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Blood and lymphatic system disorders Decreased C02 total	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Blood and lymphatic system disorders Decreased eosinophils	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Blood and lymphatic system disorders Increased serum chloride	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Blood bilirubin increased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Creatinine increased	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Gastrointestinal disorders Diarrhea	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
General disorders Fatigue	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	100.0% 3/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
General disorders Fever	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Nervous system disorders Headache	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Renal and urinary disorders Hematuria	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Vascular disorders Hypotension	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations INR increased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Psychiatric disorders Insomnia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Psychiatric disorders Anxiety	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Nervous system disorders Dizziness	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Gastrointestinal disorders Nausea	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Lymphocyte count decreased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Lymphopenia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Neutrophil count decreased	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Platelet count decreased	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Renal and urinary disorders Proteinuria	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	66.7% 2/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Infections and infestations Skin infection	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Vascular disorders Thromboembolic event	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Troponin increased	100.0% 1/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	33.3% 1/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations White blood cell decreased	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	100.0% 3/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Investigations Weight loss	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	100.0% 3/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
General disorders Edema limbs	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.
Ear and labyrinth disorders Ear pain	0.00% 0/1 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.	0.00% 0/3 • Adverse events were collected from the date of randomization until 30 days after the last study visit. Adverse event data were collected for a maximum of 580 days. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the date of randomization until 30 days after the last study visit. Adverse events were assessed by physical examination, labs, and subject self-reports. Adverse events are not reported for subjects in the "Arm Not Assigned" group because adverse events were only collected for randomized subjects from the date of randomization until 30 days after the last study visit.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: allisonallegra3@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place