Trial Outcomes & Findings for The SHUNT-V Study for Varices (NCT NCT03583996)
NCT ID: NCT03583996
Last Updated: 2025-04-11
Results Overview
The primary objective of this study is to measure the subjects' liver function using DSI ≤18.3 for those that are not likely to have large esophageal varices.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
306 participants
Primary outcome timeframe
1 day
Results posted on
2025-04-11
Participant Flow
A total of 367 subjects were screened for the study.
A total of 306 subjects were enrolled in the study. For the analyses of all primary, secondary, and exploratory endpoints, only subjects who completed the HepQuant SHUNT Test and esophagogastroduodenoscopy (EGD) examination (N=280) were considered.
Participant milestones
| Measure |
Open Label
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 24-13C-cholic acid (13C cholate) mixed with Albumin via IV push, and 40mg of 2,2,4,4-D4-cholic acid (d4 cholate) mixed with juice orally, both doses given simultaneously one time.
HepQuant SHUNT Liver Diagnostic Test: One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with chronic liver disease (CLD) and undergoing a standard of care EGD. The SHUNT test was completed prior to the EGD. Each subject received an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate.
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|---|---|
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Overall Study
STARTED
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280
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Overall Study
COMPLETED
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280
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incomplete data entry
Baseline characteristics by cohort
| Measure |
Open Label
n=280 Participants
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
HepQuant SHUNT Liver Diagnostic Test: One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test was completed prior to the EGD. Each subject received an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate.
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|---|---|
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Age, Continuous
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60.8 years
STANDARD_DEVIATION 10.44 • n=280 Participants
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Sex: Female, Male
Female
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140 Participants
n=280 Participants
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Sex: Female, Male
Male
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140 Participants
n=280 Participants
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|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
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1 Participants
n=280 Participants
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Race/Ethnicity, Customized
Race · Asian
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1 Participants
n=280 Participants
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Race/Ethnicity, Customized
Race · Black or African American
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14 Participants
n=280 Participants
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Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
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0 Participants
n=280 Participants
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Race/Ethnicity, Customized
Race · White
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257 Participants
n=280 Participants
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Race/Ethnicity, Customized
Race · Other
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7 Participants
n=280 Participants
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Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
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44 Participants
n=280 Participants
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Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
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236 Participants
n=280 Participants
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Body Mass Index (BMI)
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33.48 kg/m^2
STANDARD_DEVIATION 7.865 • n=278 Participants • Incomplete data entry
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Child-Pugh Score
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5.4 units on a scale
STANDARD_DEVIATION 0.84 • n=277 Participants • Incomplete data entry
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MELD Score
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8.2 units on a scale
STANDARD_DEVIATION 2.66 • n=264 Participants • Incomplete data entry
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PRIMARY outcome
Timeframe: 1 dayPopulation: Of the 280 subjects who completed the HepQuant SHUNT Test and EGD examination, 275 had both HepQuant SHUNT Test and EGD results.
The primary objective of this study is to measure the subjects' liver function using DSI ≤18.3 for those that are not likely to have large esophageal varices.
Outcome measures
| Measure |
Open Label
n=275 Participants
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
HepQuant SHUNT Liver Diagnostic Test: One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test was completed prior to the EGD. Each subject received an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate.
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|---|---|
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Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices
Large varices and DSI > 18.3
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33 Participants
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Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices
Large varices and DSI <= 18.3
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3 Participants
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Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices
No large varices and DSI > 18.3
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171 Participants
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Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices
No large varices and DSI <= 18.3
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68 Participants
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SECONDARY outcome
Timeframe: 1 dayPopulation: Of the 280 subjects who had the HepQuant SHUNT Test and EGD examination, 275 subjects had both HepQuant SHUNT Test and EGD.
Logistic regression analysis of DSI as predictor of large varices
Outcome measures
| Measure |
Open Label
n=275 Participants
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
HepQuant SHUNT Liver Diagnostic Test: One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test was completed prior to the EGD. Each subject received an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate.
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|---|---|
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DSI and Probability of Large Esophageal Varices
Large varices and DSI > 18.3
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33 Participants
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DSI and Probability of Large Esophageal Varices
Large varices and DSI <= 18.3
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3 Participants
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DSI and Probability of Large Esophageal Varices
No large varices and DSI > 18.3
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171 Participants
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DSI and Probability of Large Esophageal Varices
No large varices and DSI <= 18.3
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68 Participants
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Adverse Events
Open Label
Serious events: 5 serious events
Other events: 40 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open Label
n=297 participants at risk
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
HepQuant SHUNT Liver Diagnostic Test: One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test was completed prior to the EGD. Each subject received an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate.
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|---|---|
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Cardiac disorders
Coronary Artery Disease
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Respiratory, thoracic and mediastinal disorders
Pleural Effusion
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Infections and infestations
Peritonitis Bacterial
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Infections and infestations
Septic Shock
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Metabolism and nutrition disorders
Hyperosmolar State
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Nervous system disorders
Metabolic Encephalopathy
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Other adverse events
| Measure |
Open Label
n=297 participants at risk
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
HepQuant SHUNT Liver Diagnostic Test: One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test was completed prior to the EGD. Each subject received an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate.
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|---|---|
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General disorders
Infusion site bruising
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1.7%
5/297 • Number of events 8 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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General disorders
Catheter site bruise
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1.0%
3/297 • Number of events 3 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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General disorders
Infusion site pain
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Injury, poisoning and procedural complications
Contusion
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0.67%
2/297 • Number of events 2 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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Gastrointestinal disorders
Abdominal pain upper
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1.0%
3/297 • Number of events 3 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
3/297 • Number of events 3 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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|
Musculoskeletal and connective tissue disorders
Pain in extremity
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0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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|
Vascular disorders
Flushing
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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|
General disorders
Fatigue
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
General disorders
Pyrexia
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
General disorders
Vessel puncture site bruise
|
0.34%
1/297 • Number of events 2 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
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|
Injury, poisoning and procedural complications
Fall
|
1.0%
3/297 • Number of events 5 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.67%
2/297 • Number of events 2 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Gastrointestinal disorders
Constipation
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/297 • Number of events 2 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
1/297 • Number of events 2 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Infections and infestations
Corona virus infection
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Infections and infestations
Nasopharyngitis
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Infections and infestations
Otitis media acute
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Nervous system disorders
Headache
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Psychiatric disorders
Confusional state
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Psychiatric disorders
Drug abuse
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Ear and labyrinth disorders
Ear pain
|
0.34%
1/297 • Number of events 2 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Eye disorders
Eye pain
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Immune system disorders
Food allergy
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Investigations
Coronavirus test positive
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.34%
1/297 • Number of events 1 • Information regarding adverse events (AE) and/or serious adverse events (SAE) were recorded during Visit 2 (HepQuant SHUNT Test Administration, <=28 days after enrollment) and Visit 3 (Post-Test Follow-up, 2 to 30 days after Visit 2). AEs and SAEs related to the performance of the EGD were recorded (note: findings of the EGD were NOT recorded as AEs).
AEs/SAEs had their relationship to HepQuant SHUNT Liver Diagnostic Kit assessed by the clinician who examines and evaluates the participant based on temporal relationship and clinical judgment. Only 11 of the AEs below were related to HepQuant SHUNT test, and none of the intervention-related AEs were serious. Note: there were 297 subjects in the Safety Set which is different from the number of subjects that completed the study. All subjects in the Safety Set underwent the HepQuant SHUNT test.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place