Trial Outcomes & Findings for 13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF (NCT NCT02786836)
NCT ID: NCT02786836
Last Updated: 2020-12-22
Results Overview
Peak PDR is the maximal percent dose recovery (PDR) rate which reflects the maximum rate of metabolism of 13C-methacetin measured as the change in 13CO2 / 12CO2 (normal carbon dioxide) ratio after ingestion of 13C-methacetin normalized using the patient's height and weight. The distributions of mean PDR Peak values were compared between TFS (transplant free survival) and non-TFS (death/transplant) at Day 21.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
76 participants
Primary outcome timeframe
Days 1 and 21
Results posted on
2020-12-22
Participant Flow
Patients with acute liver failure (ALF) who were enrolled into the ALF Study Group Registry at 11 participating investigative U.S. sites were screened for eligibility. In March 2018, patients with acute liver injury (ALI) not related to acetaminophen overdose (APAP) and enrolled into the ALFSG Registry were included and screened for eligibility.
Participant milestones
| Measure |
13C-Methacetin Breath Test (MBT)
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® molecular correlation spectrometry (MCS) device. After completion of the baseline segment, one 75 milligram (mg) dose of 13C-Methacetin (test substrate) mixed into 150 milliliters (ml) of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 (carbon-13 dioxide) over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 for up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
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|---|---|
|
Overall Study
STARTED
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76
|
|
Overall Study
Eligible Patients Enrolled Into the Stud
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76
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
13C-Methacetin Breath Test (MBT)
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® molecular correlation spectrometry (MCS) device. After completion of the baseline segment, one 75 milligram (mg) dose of 13C-Methacetin (test substrate) mixed into 150 milliliters (ml) of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 (carbon-13 dioxide) over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 for up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Liver Transplantation
|
2
|
|
Overall Study
Device or Pharmacy Issues
|
3
|
Baseline Characteristics
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
Baseline characteristics by cohort
| Measure |
13C-Methacetin Breath Test (MBT)
n=62 Participants
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 for up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
|
|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
|
Day 1 MBT measured for a minimum of 30 minutes after ingestion of the 13C-Methacetin solution
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 21Population: Eligible patients enrolled into the study with available Day 1 13C-MBT results and 21-day outcome.
Peak PDR is the maximal percent dose recovery (PDR) rate which reflects the maximum rate of metabolism of 13C-methacetin measured as the change in 13CO2 / 12CO2 (normal carbon dioxide) ratio after ingestion of 13C-methacetin normalized using the patient's height and weight. The distributions of mean PDR Peak values were compared between TFS (transplant free survival) and non-TFS (death/transplant) at Day 21.
Outcome measures
| Measure |
13C-Methacetin Breath Test (MBT)
n=35 Participants
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes.
|
|---|---|
|
Peak Percent Dose Recovery (PDR) Value
Mean Peak PDR for TFS subjects at Day 21
|
10.2 percentage per hour
Standard Deviation 7.8
|
|
Peak Percent Dose Recovery (PDR) Value
Mean Peak PDR for non-TFS subjects at Day 21
|
1.9 percentage per hour
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: The first MBT reading either on Day 1 or Day 2 and Day 21Population: Eligible patients enrolled into the study with available Day 1 or Day 2 13C-MBT results and 21-day outcome.
This outcome is similar to the peak PDR defined in the primary outcome but as a secondary we are looking at Day 1 or Day 2 peak PDR values. Peak PDR is the maximal percent dose recovery (PDR) rate which reflects the maximum rate of metabolism of 13C-methacetin measured as the change in 13CO2 / 12CO2 ratio after ingestion of 13C-methacetin normalized using the patient's height and weight. The distributions of mean PDR Peak values were compared between TFS and non-TFS (death/transplant) at Day 21.
Outcome measures
| Measure |
13C-Methacetin Breath Test (MBT)
n=56 Participants
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes.
|
|---|---|
|
Peak Percent Dose Recovery (PDR) Value
Day 1 or 2 MBT & Day 21 TFS
|
9.1 percentage per hour
Standard Deviation 6.8
|
|
Peak Percent Dose Recovery (PDR) Value
Day 1 or 2 MBT & Day 21 non-TFS
|
2.3 percentage per hour
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: The first MBT reading either on Day 1 or Day 2 and Day 21Population: Eligible patients enrolled into the study with the initial 13C-MBT conducted on Day 1 or Day 2, and 21 day outcome.
The relationship between the cPDR (cumulative PDR of metabolized 13C-Methacetin 20 minutes after ingestion) in single time points of MBT measurements and TFS and non-TFS (death/transplant) at Day 21.
Outcome measures
| Measure |
13C-Methacetin Breath Test (MBT)
n=56 Participants
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes.
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|---|---|
|
Cumulative Percent Dose Recovery 20 (cPDR20) Value
Day 1 or 2 MBT/transplant free survival at Day 21
|
1.4 percentage per hour
Standard Deviation 1.3
|
|
Cumulative Percent Dose Recovery 20 (cPDR20) Value
Day 1 or 2 MBT & Day 21 non-TFS
|
0.2 percentage per hour
Standard Deviation .2
|
Adverse Events
13C-Methacetin Breath Test (MBT)
Serious events: 28 serious events
Other events: 40 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
13C-Methacetin Breath Test (MBT)
n=62 participants at risk
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
|
|---|---|
|
Hepatobiliary disorders
Acute hepatic failure
|
22.6%
14/62 • Number of events 14 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Nervous system disorders
Brain injury
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Hepatobiliary disorders
Liver injury
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
General disorders
Multiple organ dysfunction syndrome
|
11.3%
7/62 • Number of events 7 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Nervous system disorders
Presyncope
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Surgical and medical procedures
Transplant
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
Other adverse events
| Measure |
13C-Methacetin Breath Test (MBT)
n=62 participants at risk
For each MBT, a baseline measurement was taken for up to 15 minutes using a nasal cannula retrieval device for non-intubated patients or an airway adapter connection to the endotracheal tube of intubated patients that was connected to the Breath ID® MCS device. After completion of the baseline segment, one 75 mg dose of 13C-Methacetin (test substrate) mixed into 150 ml of water was orally ingested by non-intubated patients or administered via nasoenteric tube to intubated patients. The BreathID® MCS device measured expired 13CO2 over a period of up to 60 minutes. A maximum of 5 daily tests were administered on study days 1, 2, 3, 5 and 7 up to 1 hour after test substrate administration. Patients were contacted 21 days following study enrollment to determine vital status and to check for the development of serious adverse events.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Infections and infestations
Haemophilus infection
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Nervous system disorders
Headache
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Infections and infestations
Infection
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Hepatobiliary disorders
Jaundice
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Infections and infestations
Lung infection
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Psychiatric disorders
Mental status changes
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
3/62 • Number of events 3 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Odynophagia
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Cardiac disorders
Tachycardia
|
3.2%
2/62 • Number of events 2 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/62 • Number of events 1 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
5/62 • Number of events 5 • Serious adverse events (SAE), suspected adverse reactions (SAR) and unanticipated adverse device effects (UADE) were collected from the initiation of the first MBT through study completion (e.g. Day 21, death, liver transplant or withdrawal of consent). Non-serious adverse events (AE) and adverse device effects (ADE) were collected from from the initiation of the first MBT through Day 7.
ADEs caused by insufficiencies/inadequacies in instructions for use, deployment, implantation, installation, operation, investigational medical device malfunction, and event as a result of user error or intentional misuse. UADEs caused by/associated with a device, if effect, problem, or death was not previously identified in nature, severity, or degree of incidence in investigational plan/application on health/safety; life-threatening; or problem related to subject rights, safety, or welfare.
|
Additional Information
William M. Lee, MD
UT Southwestern Medical Center at Dallas
Phone: (214) 645-6110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place