Trial Outcomes & Findings for MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy) (NCT NCT03712280)
NCT ID: NCT03712280
Last Updated: 2021-07-20
Results Overview
This test measures the level of ammonia in your blood. Ammonia, also known as NH3, is a waste product made by your body during the digestion of protein. Normally, ammonia is processed in the liver, where it is changed into another waste product called urea. Urea is passed from the body in urine. If your body cannot process or eliminate ammonia, a lab test of a blood sample shows it has built up in the bloodstream. High ammonia levels in the blood can lead to serious health problems, including hepatic encephalopathy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline, Day 5
Results posted on
2021-07-20
Participant Flow
All 50 participants were enrolled in the United States and Puerto Rico
Participant milestones
| Measure |
Group A: MNK6106 2 Grams (Tid)
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
13
|
13
|
|
Overall Study
Safety Population
|
12
|
11
|
13
|
12
|
|
Overall Study
Modified Intent to Treat Population
|
12
|
11
|
13
|
12
|
|
Overall Study
Completed 5 Day Treatment
|
11
|
11
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
11
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group A: MNK6106 2 Grams (Tid)
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
|---|---|---|---|---|
|
Overall Study
Randomized, but not treated due to Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Participant or Caregiver
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Baseline characteristics by cohort
| Measure |
Group A: MNK6106 2 Grams (Tid)
n=12 Participants
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
n=11 Participants
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
n=13 Participants
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
n=12 Participants
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 7.95 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 9.09 • n=4 Participants
|
57.2 years
STANDARD_DEVIATION 8.84 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
48 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 5Population: modified Intent to Treat (mITT)
This test measures the level of ammonia in your blood. Ammonia, also known as NH3, is a waste product made by your body during the digestion of protein. Normally, ammonia is processed in the liver, where it is changed into another waste product called urea. Urea is passed from the body in urine. If your body cannot process or eliminate ammonia, a lab test of a blood sample shows it has built up in the bloodstream. High ammonia levels in the blood can lead to serious health problems, including hepatic encephalopathy.
Outcome measures
| Measure |
Group A: MNK6106 2 Grams (Tid)
n=12 Participants
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
n=11 Participants
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
n=13 Participants
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
n=12 Participants
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
|---|---|---|---|---|
|
Ammonia Plasma Levels at Baseline and Day 5
Baseline
|
70.4 μmol/L
Standard Deviation 23.4
|
91.4 μmol/L
Standard Deviation 35.0
|
92.6 μmol/L
Standard Deviation 34.7
|
78.1 μmol/L
Standard Deviation 25.0
|
|
Ammonia Plasma Levels at Baseline and Day 5
Day 5/Pre-Dose in the Morning
|
72.7 μmol/L
Standard Deviation 21.8
|
63.9 μmol/L
Standard Deviation 16.9
|
74.9 μmol/L
Standard Deviation 21.9
|
75.8 μmol/L
Standard Deviation 31.3
|
|
Ammonia Plasma Levels at Baseline and Day 5
Day 5/4 Hours Post Morning Dose
|
69.8 μmol/L
Standard Deviation 27.7
|
60.9 μmol/L
Standard Deviation 13.3
|
73.0 μmol/L
Standard Deviation 11.5
|
71.6 μmol/L
Standard Deviation 29.5
|
SECONDARY outcome
Timeframe: within 15 daysPopulation: Safety Population
End of trial is defined as 7 (+/-3) days after last study treatment
Outcome measures
| Measure |
Group A: MNK6106 2 Grams (Tid)
n=12 Participants
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
n=11 Participants
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
n=13 Participants
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
n=12 Participants
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events by the End of the Trial
Affected by Serious Adverse Events
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events by the End of the Trial
Affected by Any Non-serious Adverse Event
|
5 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events by the End of the Trial
Affected by Non-serious Adverse Events in the 5% Reporting Threshold
|
5 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
Adverse Events
Group A: MNK6106 2 Grams (Tid)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B: MNK6106 4 Grams (Bid)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group C: MNK6106 4 Grams (Tid)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Group D: Rifaximin 550 mg (Bid)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: MNK6106 2 Grams (Tid)
n=12 participants at risk
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
n=11 participants at risk
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
n=13 participants at risk
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
n=12 participants at risk
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
Other adverse events
| Measure |
Group A: MNK6106 2 Grams (Tid)
n=12 participants at risk
Participants receive 2 (1 gm) tablets of MNK6106 three times daily (tid) for 5 days
|
Group B: MNK6106 4 Grams (Bid)
n=11 participants at risk
Participants receive 4 (1 gm) tablets of MNK6106 twice daily (bid) for 5 days
|
Group C: MNK6106 4 Grams (Tid)
n=13 participants at risk
Participants receive 4 (1 gm) tablets of MNK6106 tid for 5 days
|
Group D: Rifaximin 550 mg (Bid)
n=12 participants at risk
Participants receive 1 (500 mg) tablet of rifaximin bid for 5 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
9.1%
1/11 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 2 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
15.4%
2/13 • Number of events 4 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 3 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
15.4%
2/13 • Number of events 3 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
General disorders
Fatigue
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
9.1%
1/11 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
9.1%
1/11 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Investigations
Urine output decreased
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
9.1%
1/11 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
15.4%
2/13 • Number of events 2 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
7.7%
1/13 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/11 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
18.2%
2/11 • Number of events 2 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
0.00%
0/13 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
16.7%
2/12 • Number of events 2 • within 15 days
All serious adverse events are reported. Non-Serious Treatment-Emergent Adverse Events reported by 5% or more participants in any treatment group are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place