Trial Outcomes & Findings for Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B (NCT NCT02881008)
NCT ID: NCT02881008
Last Updated: 2018-09-19
Results Overview
HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 12 compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
12 week
Results posted on
2018-09-19
Participant Flow
Participant milestones
| Measure |
Arm A
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Arm A
n=8 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
n=8 Participants
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
n=8 Participants
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
n=8 Participants
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
n=8 Participants
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
36.4 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
34.5 years
STANDARD_DEVIATION 6.7 • n=8 Participants
|
37.4 years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
46 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
48 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weekPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 12 compared to baseline.
Outcome measures
| Measure |
Arm A
n=8 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
n=8 Participants
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
n=8 Participants
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
n=8 Participants
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
n=8 Participants
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With HBsAg Response at 12 Week of Therapy
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg.
HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 24 compared to baseline.
Outcome measures
| Measure |
Arm A
n=8 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With HBsAg Response at 24 Week of Therapy
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.
HBV DNA response is defined as persistent reduction of HBV DNA by \>1 log IU/ml or negativation at week 12 compared to baseline.
Outcome measures
| Measure |
Arm A
n=8 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
n=8 Participants
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
n=8 Participants
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
n=8 Participants
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
n=8 Participants
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With HBV DNA Response at Week 12 of Therapy
|
2 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only patients with abnormal ALT levels at baseline were included in data analysis.
Biochemical response is defined as normalization of ALT level at week 12 compared to baseline.
Outcome measures
| Measure |
Arm A
n=7 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=7 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
n=8 Participants
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
n=7 Participants
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
n=4 Participants
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
n=6 Participants
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With Biochemical Response at 12 Weeks of Therapy
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Virological cccDNA response was to be estimated only for patients of group F administered 24-week therapy with Myrcludex B in the dose of 10 mg and to whom liver biopsy during screening period and at week 24 was performed.
Virological cccDNA response is defined as reduction of intrahepatic cccDNA by 0.5 logs in comparison to baseline at week 24.
Outcome measures
| Measure |
Arm A
n=5 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With cccDNA Response at 24 Week of Therapy
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg.
HBV DNA response is defined as persistent reduction of HBV DNA by \>1 log IU/ml or negativation at week 24 compared to baseline.
Outcome measures
| Measure |
Arm A
n=8 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With HBV DNA Response at Week 24 of Therapy
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg. Only patients with abnormal ALT levels at baseline were included in data analysis.
Biochemical response is defined as normalization of ALT level at week 24 compared to baseline.
Outcome measures
| Measure |
Arm A
n=7 Participants
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=6 Participants
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Proportion of Patients With Biochemical Response at 24 Weeks of Therapy
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm C
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm E
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm F
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=8 participants at risk
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 participants at risk
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
n=8 participants at risk
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
n=8 participants at risk
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
n=8 participants at risk
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
n=8 participants at risk
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
Other adverse events
| Measure |
Arm A
n=8 participants at risk
Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm B
n=8 participants at risk
Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm C
n=8 participants at risk
Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm D
n=8 participants at risk
Entecavir 0.5 mg daily for 24 weeks
|
Arm E
n=8 participants at risk
Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period
|
Arm F
n=8 participants at risk
Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Injection site dermatitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
37.5%
3/8 • Number of events 5
|
|
General disorders
Injection site reaction
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Pyrexia
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Influenza
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Amylase increased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Eosinophilia
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Body temperature increased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Lipase increased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Weight decreased
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Somnolence
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER