Trial Outcomes & Findings for N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure (NCT NCT00248625)
NCT ID: NCT00248625
Last Updated: 2016-07-28
Results Overview
Spontaneous survival without transplant plus survival following transplantation
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
184 participants
Primary outcome timeframe
One year following randomization
Results posted on
2016-07-28
Participant Flow
Participants were from an established registry of children with acute liver failure. Entry criteria: children \<18 years, absence of a known chronic liver disease, biochemical evidence of acute liver injury, and a liver-based coagulopathy. Evidence of hepatic encephalopathy was required if the prothrombin time (PT) was between 15-19.9 seconds
Participant milestones
| Measure |
Placebo
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.
Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications.
|
N-acetylcysteine (NAC)
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.
N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
|
Overall Study
COMPLETED
|
92
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.
Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications.
|
N-acetylcysteine (NAC)
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.
N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
Baseline characteristics by cohort
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
92 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.7 years
n=5 Participants
|
4.5 years
n=7 Participants
|
4.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
68 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=5 Participants
|
21 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Coma Grade of Hepatic Encephalopathy
0-1
|
65 participants
n=5 Participants
|
68 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Coma Grade of Hepatic Encephalopathy
2-4
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year following randomizationPopulation: All participants who were enrolled in the study were included in the survival analysis
Spontaneous survival without transplant plus survival following transplantation
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Survival
|
68 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: One year following randomizationPopulation: All participants enrolled in study
Survival without liver transplantation
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Spontaneous Recovery
|
33 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Within 1 year of randomizationOutcome measures
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Cumulative Percent Incidence of Transplantation by 1 Year
|
45 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to hospital dischargePopulation: All participants enrolled in study with hospital stay information, 2 participants (1 in each arm) did not have hospital discharge information.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=91 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=91 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Length of Hospital Stay
|
103 days
Interval 13.0 to 103.0
|
21 days
Interval 9.0 to 103.0
|
SECONDARY outcome
Timeframe: Within 7 days of randomizationThe length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Categorized Length of ICU Stay
1 day
|
3 participants
|
4 participants
|
|
Categorized Length of ICU Stay
0 days
|
29 participants
|
34 participants
|
|
Categorized Length of ICU Stay
2 days
|
3 participants
|
4 participants
|
|
Categorized Length of ICU Stay
3 days
|
2 participants
|
0 participants
|
|
Categorized Length of ICU Stay
4 days
|
1 participants
|
3 participants
|
|
Categorized Length of ICU Stay
5 days
|
4 participants
|
3 participants
|
|
Categorized Length of ICU Stay
6 days
|
5 participants
|
3 participants
|
|
Categorized Length of ICU Stay
7 days
|
9 participants
|
14 participants
|
|
Categorized Length of ICU Stay
underwent LTx w/i 7 days of randomization
|
28 participants
|
22 participants
|
|
Categorized Length of ICU Stay
died w/o LTx w/i 7 days of randomization
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Within 7 days of randomizationOutcome measures
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Number of Organ Systems Failing
0
|
44 participants
|
46 participants
|
|
Number of Organ Systems Failing
1
|
21 participants
|
23 participants
|
|
Number of Organ Systems Failing
2
|
15 participants
|
12 participants
|
|
Number of Organ Systems Failing
3
|
11 participants
|
8 participants
|
|
Number of Organ Systems Failing
4
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Within 7 days of randomizationPopulation: All enrolled participants where coma grade could be assessed. Four participants (two in each randomization arm) could not have coma grade assessed during the 7 days after randomization.
West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants \> 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing.
Outcome measures
| Measure |
N-acetylcysteine (NAC)
n=90 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=90 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Highest Coma Grade of Hepatic Encephalopathy
0
|
28 participants
|
27 participants
|
|
Highest Coma Grade of Hepatic Encephalopathy
I
|
16 participants
|
21 participants
|
|
Highest Coma Grade of Hepatic Encephalopathy
II
|
20 participants
|
19 participants
|
|
Highest Coma Grade of Hepatic Encephalopathy
III
|
15 participants
|
17 participants
|
|
Highest Coma Grade of Hepatic Encephalopathy
IV
|
11 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Within 7 days of randomizationOutcome measures
| Measure |
N-acetylcysteine (NAC)
n=92 Participants
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
|
Placebo
n=92 Participants
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study
|
|---|---|---|
|
Infectious Complication
|
20 Participants
|
21 Participants
|
Adverse Events
N-acetylcysteine (NAC)
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N-acetylcysteine (NAC)
n=92 participants at risk
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days
N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
|
Placebo
n=92 participants at risk
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Infections and infestations
Bacteremia
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Cardiac disorders
Bradycardiac episode
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Endocrine disorders
Hypoglycemia
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Aplastic Anemia
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Infections and infestations
Epstein-Barr virus
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Infections and infestations
Fever, chills, sinusitis
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Gastrointestinal disorders
Small intestine ulcerations
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
General disorders
Fever
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Cardiac disorders
Bigeminy
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
Other adverse events
| Measure |
N-acetylcysteine (NAC)
n=92 participants at risk
Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days
N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge.
|
Placebo
n=92 participants at risk
Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive
Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.
|
|---|---|---|
|
Infections and infestations
Infection
|
12.0%
11/92 • Seven day randomization treatment period
Regular investigator assessment
|
8.7%
8/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
4/92 • Seven day randomization treatment period
Regular investigator assessment
|
2.2%
2/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Cardiac disorders
Arrhythmia
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
4.3%
4/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Eye disorders
Dilated and fixed pupils
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Vascular disorders
Hypertension
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
0.00%
0/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
General disorders
Sleepiness
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
|
General disorders
High Fever
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
1.1%
1/92 • Seven day randomization treatment period
Regular investigator assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place