Trial Outcomes & Findings for Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH) (NCT NCT02855164)
NCT ID: NCT02855164
Last Updated: 2021-09-05
Results Overview
Number of Nonalcoholic steatohepatitis (NASH) patients with TEAEs
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
350 participants
Primary outcome timeframe
End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)
Results posted on
2021-09-05
Participant Flow
In total, 411 subjects were screened in Parts A and B of the study together. Of these, 198 subjects were deemed eligible to participate in the study and were subsequently randomized
In Part A, 77 were randomized at baseline to receive tropifexor 10 μg (n=14), 30μg (n=16), 60 μg (n=16) or 90 μg (n=15) or placebo (n=16) In Part B, 121 were randomized at baseline to receive tropifexor 90 μg (n=70) and 60 μg (n=21) or placebo (n=30) 780 were screened in Part C. Of these 152 met eligibility criteria and were randomized to receive tropifexor 140 μg (n=50) or 200 μg (n=51) or placebo (n=51)
Participant milestones
| Measure |
LJN452 10 μg
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A + B)
|
Placebo A+B
Placebo A+B
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LJN452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Parts A + B (Randomized Set)
STARTED
|
14
|
16
|
37
|
85
|
46
|
0
|
0
|
0
|
|
Parts A + B (Randomized Set)
COMPLETED
|
14
|
16
|
36
|
77
|
45
|
0
|
0
|
0
|
|
Parts A + B (Randomized Set)
NOT COMPLETED
|
0
|
0
|
1
|
8
|
1
|
0
|
0
|
0
|
|
Part C (Randomized Set)
STARTED
|
0
|
0
|
0
|
0
|
0
|
50
|
51
|
51
|
|
Part C (Randomized Set)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
38
|
37
|
44
|
|
Part C (Randomized Set)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
14
|
7
|
Reasons for withdrawal
| Measure |
LJN452 10 μg
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A + B)
|
Placebo A+B
Placebo A+B
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LJN452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Parts A + B (Randomized Set)
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
|
Parts A + B (Randomized Set)
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Parts A + B (Randomized Set)
Adverse Event
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Part C (Randomized Set)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
5
|
9
|
2
|
|
Part C (Randomized Set)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Part C (Randomized Set)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Part C (Randomized Set)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
5
|
4
|
3
|
Baseline Characteristics
FAS
Baseline characteristics by cohort
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A + B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LJN452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo C
n=51 Participants
Placebo (Part C)
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
Parts A + B · <=18 years
|
0 Participants
n=14 Participants • FAS
|
0 Participants
n=16 Participants • FAS
|
0 Participants
n=37 Participants • FAS
|
0 Participants
n=85 Participants • FAS
|
0 Participants
n=46 Participants • FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
n=198 Participants • FAS
|
|
Age, Categorical
Parts A + B · Between 18 and 65 years
|
14 Participants
n=14 Participants • FAS
|
14 Participants
n=16 Participants • FAS
|
33 Participants
n=37 Participants • FAS
|
72 Participants
n=85 Participants • FAS
|
41 Participants
n=46 Participants • FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
174 Participants
n=198 Participants • FAS
|
|
Age, Categorical
Parts A + B · >=65 years
|
0 Participants
n=14 Participants • FAS
|
2 Participants
n=16 Participants • FAS
|
4 Participants
n=37 Participants • FAS
|
13 Participants
n=85 Participants • FAS
|
5 Participants
n=46 Participants • FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
24 Participants
n=198 Participants • FAS
|
|
Age, Categorical
Part C · <=18 years
|
—
|
—
|
—
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
n=50 Participants • FAS
|
0 Participants
n=51 Participants • FAS
|
0 Participants
n=51 Participants • FAS
|
0 Participants
n=152 Participants • FAS
|
|
Age, Categorical
Part C · Between 18 and 65 years
|
—
|
—
|
—
|
0 Participants
FAS
|
—
|
40 Participants
n=50 Participants • FAS
|
41 Participants
n=51 Participants • FAS
|
43 Participants
n=51 Participants • FAS
|
124 Participants
n=152 Participants • FAS
|
|
Age, Categorical
Part C · >=65 years
|
—
|
—
|
—
|
0 Participants
FAS
|
—
|
10 Participants
n=50 Participants • FAS
|
10 Participants
n=51 Participants • FAS
|
8 Participants
n=51 Participants • FAS
|
28 Participants
n=152 Participants • FAS
|
|
Age, Continuous
Parts A + B
|
48 years
STANDARD_DEVIATION 11.7 • n=14 Participants • Full Analysis Set
|
49 years
STANDARD_DEVIATION 14.4 • n=16 Participants • Full Analysis Set
|
50 years
STANDARD_DEVIATION 12.5 • n=37 Participants • Full Analysis Set
|
51 years
STANDARD_DEVIATION 13.4 • n=85 Participants • Full Analysis Set
|
51 years
STANDARD_DEVIATION 12.3 • n=46 Participants • Full Analysis Set
|
—
|
—
|
—
|
51 years
STANDARD_DEVIATION 12.8 • n=198 Participants • Full Analysis Set
|
|
Age, Continuous
Part C
|
—
|
—
|
—
|
—
|
—
|
56 years
STANDARD_DEVIATION 11.41 • n=50 Participants • Full Analysis Set
|
55 years
STANDARD_DEVIATION 10.8 • n=51 Participants • Full Analysis Set
|
54 years
STANDARD_DEVIATION 11.0 • n=51 Participants • Full Analysis Set
|
55 years
STANDARD_DEVIATION 11.0 • n=152 Participants • Full Analysis Set
|
|
Sex: Female, Male
Parts A + B · Female
|
9 Participants
n=14 Participants • FAS
|
7 Participants
n=16 Participants • FAS
|
20 Participants
n=37 Participants • FAS
|
47 Participants
n=85 Participants • FAS
|
21 Participants
n=46 Participants • FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
104 Participants
n=198 Participants • FAS
|
|
Sex: Female, Male
Parts A + B · Male
|
5 Participants
n=14 Participants • FAS
|
9 Participants
n=16 Participants • FAS
|
17 Participants
n=37 Participants • FAS
|
38 Participants
n=85 Participants • FAS
|
25 Participants
n=46 Participants • FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
94 Participants
n=198 Participants • FAS
|
|
Sex: Female, Male
Part C · Female
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
36 Participants
n=50 Participants • FAS
|
29 Participants
n=51 Participants • FAS
|
32 Participants
n=51 Participants • FAS
|
97 Participants
n=152 Participants • FAS
|
|
Sex: Female, Male
Part C · Male
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
0 Participants
FAS
|
14 Participants
n=50 Participants • FAS
|
22 Participants
n=51 Participants • FAS
|
19 Participants
n=51 Participants • FAS
|
55 Participants
n=152 Participants • FAS
|
|
Race/Ethnicity, Customized
Caucasian (Parts A + B)
|
12 Participants
n=14 Participants • FAS
|
11 Participants
n=16 Participants • FAS
|
24 Participants
n=37 Participants • FAS
|
50 Participants
n=85 Participants • FAS
|
25 Participants
n=46 Participants • FAS
|
—
|
—
|
—
|
122 Participants
n=198 Participants • FAS
|
|
Race/Ethnicity, Customized
Black (Parts A + B)
|
0 Participants
n=14 Participants • FAS
|
0 Participants
n=16 Participants • FAS
|
0 Participants
n=37 Participants • FAS
|
1 Participants
n=85 Participants • FAS
|
0 Participants
n=46 Participants • FAS
|
—
|
—
|
—
|
1 Participants
n=198 Participants • FAS
|
|
Race/Ethnicity, Customized
Asian (Parts A + B)
|
2 Participants
n=14 Participants • FAS
|
5 Participants
n=16 Participants • FAS
|
12 Participants
n=37 Participants • FAS
|
31 Participants
n=85 Participants • FAS
|
20 Participants
n=46 Participants • FAS
|
—
|
—
|
—
|
70 Participants
n=198 Participants • FAS
|
|
Race/Ethnicity, Customized
Pacific Islander (Parts A + B)
|
0 Participants
n=14 Participants • FAS
|
0 Participants
n=16 Participants • FAS
|
0 Participants
n=37 Participants • FAS
|
0 Participants
n=85 Participants • FAS
|
1 Participants
n=46 Participants • FAS
|
—
|
—
|
—
|
1 Participants
n=198 Participants • FAS
|
|
Race/Ethnicity, Customized
Other (Parts A + B)
|
0 Participants
n=14 Participants • FAS
|
0 Participants
n=16 Participants • FAS
|
0 Participants
n=37 Participants • FAS
|
2 Participants
n=85 Participants • FAS
|
0 Participants
n=46 Participants • FAS
|
—
|
—
|
—
|
2 Participants
n=198 Participants • FAS
|
|
Race/Ethnicity, Customized
Unknown (Parts A+B)
|
0 Participants
n=14 Participants • FAS
|
1 Participants
n=16 Participants • FAS
|
1 Participants
n=37 Participants • FAS
|
1 Participants
n=85 Participants • FAS
|
—
|
—
|
—
|
—
|
3 Participants
n=152 Participants • FAS
|
|
Race/Ethnicity, Customized
Caucasian (Part C)
|
—
|
—
|
—
|
—
|
—
|
37 Participants
n=50 Participants • FAS
|
38 Participants
n=51 Participants • FAS
|
38 Participants
n=51 Participants • FAS
|
113 Participants
n=152 Participants • FAS
|
|
Race/Ethnicity, Customized
Black (Part C)
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=50 Participants • FAS
|
0 Participants
n=51 Participants • FAS
|
1 Participants
n=51 Participants • FAS
|
1 Participants
n=152 Participants • FAS
|
|
Race/Ethnicity, Customized
Asian (Part C)
|
—
|
—
|
—
|
—
|
—
|
10 Participants
n=50 Participants • FAS
|
10 Participants
n=51 Participants • FAS
|
8 Participants
n=51 Participants • FAS
|
28 Participants
n=152 Participants • FAS
|
|
Race/Ethnicity, Customized
Pacific Islander (Part C)
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=50 Participants • FAS
|
0 Participants
n=51 Participants • FAS
|
0 Participants
n=51 Participants • FAS
|
1 Participants
n=152 Participants • FAS
|
|
Race/Ethnicity, Customized
Other (Part C)
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=50 Participants • FAS
|
3 Participants
n=51 Participants • FAS
|
4 Participants
n=51 Participants • FAS
|
9 Participants
n=152 Participants • FAS
|
PRIMARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)Population: Safety analysis set (SAS) is all subjects who received at least one dose of drug and had at least one post-baseline safety assessment.
Number of Nonalcoholic steatohepatitis (NASH) patients with TEAEs
Outcome measures
| Measure |
LJN452 10 μg
n=13 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=17 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE)
|
5 Participants
|
11 Participants
|
24 Participants
|
61 Participants
|
31 Participants
|
49 Participants
|
49 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)Population: Full analysis set (FAS): All subjects to whom study treatment had been assigned. Following the intent-to-treat (ITT) principle, subjects were analyzed according to the treatment they have been assigned to at randomization.
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. High levels of ALT may indicate liver damage. Normal range for ALT is typically 10 to 45 U/L or so (varies a little by age and gender). Elevation of these values indicate more liver inflammation/damage. ALT elevation is not unexpected in this patient population Dose relationship of tropifexor (LJN452) on ALT marker of hepatic inflammation in NASH from baseline to week 12 Summary statistics of change in ALT from baseline to EOT by treatment
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change in Transaminase Levels (ALT)
|
-16.7 IU/L
Standard Deviation 17.53
|
-12.0 IU/L
Standard Deviation 35.99
|
-17.3 IU/L
Standard Deviation 28.12
|
-15.4 IU/L
Standard Deviation 30.32
|
-8.1 IU/L
Standard Deviation 29.37
|
-27.0 IU/L
Standard Deviation 30.24
|
-28.7 IU/L
Standard Deviation 25.40
|
-11.7 IU/L
Standard Deviation 61.64
|
PRIMARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)Population: Full Analysis Set (FAS)
To determine the dose relationship of tropifexor (LJN452) on markers of hepatic inflammation (AST) in NASH from baseline to Week 12 The alanine aminotransferase (AST) test is a blood test that checks for liver damage. High levels of AST may indicate liver damage. Normal range for AST is typically 10 to 45 U/L or so (varies a little by age and gender). Elevation of these values indicate more liver inflammation/damage AST elevation is not unexpected in this patient population The aspartate aminotransferase (AST) test is a blood test that checks for liver damage. Higher levels indicate more possible liver damage Summary statistics of change in AST from baseline up to end of treatment (EOT)
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change in Aspartate Transaminase (AST)
|
-11.3 U/L
Standard Deviation 12.09
|
-2.1 U/L
Standard Deviation 29.62
|
-10.2 U/L
Standard Deviation 25.03
|
-2.5 U/L
Standard Deviation 24.60
|
-7.1 U/L
Standard Deviation 23.85
|
-16.7 U/L
Standard Deviation 23.36
|
-13.3 U/L
Standard Deviation 20.14
|
-13.1 U/L
Standard Deviation 29.00
|
PRIMARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12 (Primary Outcome Measure). For Part C, EoT was Week 48 (Secondary Outcome Measure)Population: FAS
Repeated measures analysis: Relative change in percentage of fat in the liver assessed using MRI from baseline by visit up to EOT (Full analysis set)
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in % of Fat in the Liver Assessed Using Magnetic Resonance Imaging (MRI)
|
-7.48 percentage of fat in the liver
Standard Error 6.174
|
-14.07 percentage of fat in the liver
Standard Error 5.661
|
-15.04 percentage of fat in the liver
Standard Error 3.754
|
-12.34 percentage of fat in the liver
Standard Error 2.482
|
-6.19 percentage of fat in the liver
Standard Error 3.381
|
-31.25 percentage of fat in the liver
Standard Error 5.228
|
-39.54 percentage of fat in the liver
Standard Error 4.968
|
-3.58 percentage of fat in the liver
Standard Error 4.718
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: FAS
Repeated measures for LS mean change in weight after 12 weeks of treatment
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=36 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=84 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weight
|
-1.79 kg
Standard Error 0.608
|
-0.78 kg
Standard Error 0.567
|
-1.05 kg
Standard Error 0.377
|
-1.15 kg
Standard Error 0.253
|
0.00 kg
Standard Error 0.338
|
-5.10 kg
Standard Error 0.988
|
-5.89 kg
Standard Error 1.002
|
-2.48 kg
Standard Error 0.915
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
Repeated measures for the LS mean change in BMI after 12 weeks of treatment. Body mass index (BMI) is a measure of body fat based on height and weight
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=84 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=50 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=51 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.64 kg/m2
Standard Error 0.208
|
-0.29 kg/m2
Standard Error 0.194
|
-0.35 kg/m2
Standard Error 0.129
|
-0.42 kg/m2
Standard Error 0.087
|
0.02 kg/m2
Standard Error 0.116
|
-1.88 kg/m2
Standard Error 0.322
|
-2.11 kg/m2
Standard Error 0.327
|
-0.80 kg/m2
Standard Error 0.299
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: FAS
The LS mean change in waist to hip ratio after 12 weeks of treatment
Outcome measures
| Measure |
LJN452 10 μg
n=13 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=15 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=84 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=49 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=37 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Waist to Hip (WTH) Ratio
|
-0.01 ratio
Standard Error 0.009
|
0.00 ratio
Standard Error 0.008
|
-0.01 ratio
Standard Error 0.005
|
0.00 ratio
Standard Error 0.004
|
0.00 ratio
Standard Error 0.005
|
0.00 ratio
Standard Error 0.008
|
-0.01 ratio
Standard Error 0.007
|
-0.02 ratio
Standard Error 0.007
|
SECONDARY outcome
Timeframe: baseline, week 6Population: FAS
Dose-response relationship of tropifexor (LJN452) on FGF19 over time, a marker of FXR target engagement in the gut. ANCOVA: Ratio of FGF19 (pg/mL) post-dose to pre-dose at Week 6 Value at 6 weeks minus value at baseline
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=15 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=34 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=78 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=42 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=47 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=42 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Biomarker FGF19
|
1.45 pg/mL
Interval 0.93 to 2.26
|
1.53 pg/mL
Interval 1.0 to 2.35
|
3.82 pg/mL
Interval 2.88 to 5.09
|
5.78 pg/mL
Interval 4.78 to 6.98
|
1.33 pg/mL
Interval 1.03 to 1.73
|
1.97 pg/mL
Interval 1.48 to 2.62
|
2.23 pg/mL
Interval 1.65 to 3.01
|
1.22 pg/mL
Interval 0.92 to 1.61
|
SECONDARY outcome
Timeframe: Week 6, 4 hours post dosePopulation: FAS
Dose-response relationship of LJN452 on C4, a marker of hepatic target engagement at 4 hours post dose C4 (ng/mL): Summary statistics by treatment and visit
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=15 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=47 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Biomarker C4
|
38.82 ng/mL
Standard Deviation 25.765
|
32.75 ng/mL
Standard Deviation 23.360
|
28.38 ng/mL
Standard Deviation 13.394
|
40.19 ng/mL
Standard Deviation 31.356
|
47.70 ng/mL
Standard Deviation 25.524
|
14.97 ng/mL
Standard Deviation 20.232
|
8.54 ng/mL
Standard Deviation 9.583
|
38.40 ng/mL
Standard Deviation 24.552
|
SECONDARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48Population: FAS
Dose-response relationship of tropifexor (LJN452) on markers of liver fibrosis commonly available such as Fibroscan® Liver stiffness (kPa): Summary statistics by treatment and visit FibroScan is a specialized ultrasound machine for measuring fibrosis (scarring) in the liver Scores range from 0-4 with zero being no liver scarring and 4 being advanced liver scarring (cirrhosis)
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=46 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Markers of Liver Fibrosis, Fibroscan
|
10.94 scores
Standard Deviation 5.314
|
10.40 scores
Standard Deviation 7.663
|
9.90 scores
Standard Deviation 4.095
|
9.00 scores
Standard Deviation 4.152
|
9.30 scores
Standard Deviation 4.676
|
11.29 scores
Standard Deviation 3.677
|
12.03 scores
Standard Deviation 4.804
|
11.26 scores
Standard Deviation 4.027
|
SECONDARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48Population: FAS
ANCOVA: LS Mean Change in Enhanced liver fibrosis panel (ELF) score from baseline by visit up to EOT. The total ELF score reference range calculated non-parametrically is 6.72 (90% CI 6.58-6.84) to 9.79 (90% CI 9.45-10.01); Journal of Hepatology 2013 vol. 59 j 236-242. Enhanced liver fibrosis Test (ELF) panel: the following was assessed: hyaluronic acid (HA), tissue inhibitor of metalloproteinases (TIMP-1), and amino-terminal pro-peptide of procollagen type III (PIIINP). The Enhanced Liver Fibrosis score is a linear combination of TIMP-1, PIIINP, and HA with the following formula: ELF score = 2.494+0.846 x ln(HA) + 0.735 x ln (PIIINP) + 0.391 x ln (TIMP-1).
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=34 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=78 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=47 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=51 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Markers of Liver Fibrosis Panel (ELF) Score
|
0.05 scores on a scale
Standard Error 0.158
|
0.00 scores on a scale
Standard Error 0.146
|
-0.19 scores on a scale
Standard Error 0.097
|
0.20 scores on a scale
Standard Error 0.064
|
0.08 scores on a scale
Standard Error 0.087
|
-0.34 scores on a scale
Standard Error 0.132
|
-0.24 scores on a scale
Standard Error 0.122
|
-0.08 scores on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: End of Treatment (EoT):12 weeksPopulation: FAS
Fibrosis biomarker test, originally called Fibrotest®/ Fibrosure®, is combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT. The coefficient for the score is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e\^-z). Calculated scores range from 0.00 (no fibrosis) to 1.00 (severe fibrosis or cirrhosis) (See Part C in separate outcomes that follows)
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Markers of Liver Fibrosis, Fibrotest (Parts A+B)
|
-0.23 scores
Standard Deviation 0.284
|
-1.49 scores
Standard Deviation 0.852
|
-1.44 scores
Standard Deviation 1.080
|
-1.34 scores
Standard Deviation 1.222
|
-1.23 scores
Standard Deviation 1.088
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End of Treatment (EoT) was 48 weeksPopulation: FAS
Fibrosis biomarker test, originally called Fibrotest®/ Fibrosure®, is combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT. The coefficient for the score is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e\^-z). Calculated scores range from 0.00 (no fibrosis) to 1.00 (severe fibrosis or cirrhosis)
Outcome measures
| Measure |
LJN452 10 μg
n=34 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=28 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Markers of Liver Fibrosis, Fibrotest, (Part C)
|
-0.42 scores
Standard Error 0.131
|
-0.44 scores
Standard Error 0.135
|
-0.17 scores
Standard Error 0.119
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EoT for Parts A+B=12 weeks; EoT for Part C = 48 weeksPopulation: FAS
Summary statistics of change in GGT (IU/L) from baseline by visit up to EoT
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=15 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=84 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=78 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=51 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=36 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Gamma-glutamyl Transferase (GGT)
|
1.6 IU/L
Standard Error 10.93
|
-29.9 IU/L
Standard Error 10.11
|
-34.2 IU/L
Standard Error 6.70
|
-45.7 IU/L
Standard Error 4.52
|
-5.0 IU/L
Standard Error 6.10
|
-35.2 IU/L
Standard Error 11.58
|
-29.9 IU/L
Standard Error 11.65
|
9.0 IU/L
Standard Error 10.72
|
SECONDARY outcome
Timeframe: End of Treatment (EoT): For Parts A&B, EoT was Week 12. For Part C, EoT was Week 48Population: FAS
Repeated measures analysis: LS geometric mean ratio of fasting lipids to baseline by visit up to EOT
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=50 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=46 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=46 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=37 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline on Fasting Lipid Profile
LDL Cholesterol
|
0.923 mmol/L
Interval 0.834 to 1.02
|
1.044 mmol/L
Interval 0.953 to 1.142
|
1.092 mmol/L
Interval 1.029 to 1.159
|
1.104 mmol/L
Interval 1.06 to 1.15
|
0.943 mmol/L
Interval 0.893 to 0.995
|
1.056 mmol/L
Interval 0.972 to 1.147
|
1.200 mmol/L
Interval 1.106 to 1.302
|
0.973 mmol/L
Interval 0.903 to 1.049
|
|
Change From Baseline on Fasting Lipid Profile
Free Glycerol
|
1.0563 mmol/L
Interval 0.8722 to 1.2793
|
0.9376 mmol/L
Interval 0.7859 to 1.1185
|
0.9128 mmol/L
Interval 0.8112 to 1.0272
|
0.9915 mmol/L
Interval 0.9151 to 1.0743
|
0.9604 mmol/L
Interval 0.8641 to 1.0674
|
1.1115 mmol/L
Interval 0.9721 to 1.2709
|
0.9808 mmol/L
Interval 0.8571 to 1.1223
|
0.9846 mmol/L
Interval 0.8722 to 1.11116
|
|
Change From Baseline on Fasting Lipid Profile
Free Fatty Acid
|
1.082 mmol/L
Interval 0.897 to 1.305
|
0.864 mmol/L
Interval 0.726 to 1.028
|
0.929 mmol/L
Interval 0.827 to 1.043
|
0.947 mmol/L
Interval 0.874 to 1.025
|
0.936 mmol/L
Interval 0.844 to 1.038
|
1.072 mmol/L
Interval 0.951 to 1.208
|
0.887 mmol/L
Interval 0.785 to 1.002
|
0.977 mmol/L
Interval 0.928 to 1.029
|
|
Change From Baseline on Fasting Lipid Profile
Cholesterol
|
0.949 mmol/L
Interval 0.888 to 1.014
|
1.003 mmol/L
Interval 0.945 to 1.065
|
1.029 mmol/L
Interval 0.989 to 1.07
|
1.029 mmol/L
Interval 1.002 to 1.057
|
0.956 mmol/L
Interval 0.923 to 0.991
|
1.032 mmol/L
Interval 0.975 to 1.093
|
1.071 mmol/L
Interval 1.012 to 1.133
|
0.977 mmol/L
Interval 0.928 to 1.029
|
|
Change From Baseline on Fasting Lipid Profile
Triglycerides
|
0.920 mmol/L
Interval 0.766 to 1.091
|
0.919 mmol/L
Interval 0.789 to 1.071
|
0.960 mmol/L
Interval 0.868 to 1.062
|
1.048 mmol/L
Interval 0.978 to 1.123
|
0.991 mmol/L
Interval 0.904 to 1.085
|
1.070 mmol/L
Interval 0.934 to 1.226
|
1.068 mmol/L
Interval 0.936 to 1.219
|
0.883 mmol/L
Interval 0.782 to 0.998
|
|
Change From Baseline on Fasting Lipid Profile
HDL Cholesterol
|
1.019 mmol/L
Interval 0.946 to 1.096
|
1.001 mmol/L
Interval 0.937 to 1.069
|
0.961 mmol/L
Interval 0.92 to 1.004
|
0.897 mmol/L
Interval 0.87 to 0.924
|
0.959 mmol/L
Interval 0.922 to 0.998
|
0.855 mmol/L
Interval 0.8 to 0.913
|
0.824 mmol/L
Interval 0.772 to 0.879
|
1.033 mmol/L
Interval 0.973 to 1.096
|
|
Change From Baseline on Fasting Lipid Profile
LDL/HDL Ratio
|
0.921 mmol/L
Interval 0.81 to 1.047
|
1.058 mmol/L
Interval 0.942 to 1.188
|
1.139 mmol/L
Interval 1.055 to 1.229
|
1.227 mmol/L
Interval 1.165 to 1.293
|
0.980 mmol/L
Interval 0.915 to 1.051
|
1.252 mmol/L
Interval 1.128 to 1.39
|
1.478 mmol/L
Interval 1.332 to 1.639
|
0.947 mmol/L
Interval 0.862 to 1.041
|
SECONDARY outcome
Timeframe: EoT for Parts A+B=12 weeks; EoT for Part C = 48 weeksPopulation: FAS
Repeated measures analysis: Change in VAS for Itch from baseline by visit up to EoT VAS score 0 = no disease; and 9 is severely advanced disease
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=36 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=78 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=39 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=47 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
n=42 Participants
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
n=37 Participants
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Itch Based on a Visual Analog Scale (VAS) Rating Scale
|
-0.3 scores
Standard Error 0.48
|
0.2 scores
Standard Error 0.43
|
0.4 scores
Standard Error 0.28
|
0.1 scores
Standard Error 0.19
|
0.6 scores
Standard Error 0.27
|
0.6 scores
Standard Error 0.37
|
1.1 scores
Standard Error 0.35
|
0.3 scores
Standard Error 0.33
|
SECONDARY outcome
Timeframe: In Parts A and B, LJN452 Ctrough was measured on Study Days 7, 14, 28, 42, 56, and 84. In Part C LJN452 Ctrough was measured on Study Days 42, 84, 168, 280 and 336Population: FAS
Pre-dose Trough Concentration (Ctrough) of tropifexor (LJN452)
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
n=37 Participants
Placebo (Parts A+B)
|
LJN452 140 μg
n=51 Participants
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 7
|
0.142 ng/mL
Standard Deviation 0.119
|
0.355 ng/mL
Standard Deviation 0.194
|
0.638 ng/mL
Standard Deviation 0.453
|
1.215 ng/mL
Standard Deviation 0.593
|
—
|
—
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 14
|
0.216 ng/mL
Standard Deviation 0.127
|
0.505 ng/mL
Standard Deviation 0.328
|
0.626 ng/mL
Standard Deviation 0.281
|
1.115 ng/mL
Standard Deviation 0.693
|
—
|
—
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 28
|
0.118 ng/mL
Standard Deviation 0.087
|
0.411 ng/mL
Standard Deviation 0.250
|
0.639 ng/mL
Standard Deviation 0.265
|
1.027 ng/mL
Standard Deviation 0.700
|
—
|
—
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 42
|
0.161 ng/mL
Standard Deviation 0.094
|
0.382 ng/mL
Standard Deviation 0.150
|
0.647 ng/mL
Standard Deviation 0.344
|
1.032 ng/mL
Standard Deviation 0.661
|
2.821 ng/mL
Standard Deviation 1.659
|
3.533 ng/mL
Standard Deviation 2.356
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 56
|
0.168 ng/mL
Standard Deviation 0.088
|
0.474 ng/mL
Standard Deviation 0.273
|
0.637 ng/mL
Standard Deviation 0.278
|
1.041 ng/mL
Standard Deviation 0.701
|
—
|
—
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 84
|
0.118 ng/mL
Standard Deviation 0.080
|
0.366 ng/mL
Standard Deviation 0.147
|
0.530 ng/mL
Standard Deviation 0.357
|
1.095 ng/mL
Standard Deviation 0.653
|
1.685 ng/mL
Standard Deviation 0.874
|
2.286 ng/mL
Standard Deviation 1.259
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 168
|
—
|
—
|
—
|
—
|
1.889 ng/mL
Standard Deviation 1.340
|
2.146 ng/mL
Standard Deviation 1.383
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 280
|
—
|
—
|
—
|
—
|
2.129 ng/mL
Standard Deviation 1.257
|
1.990 ng/mL
Standard Deviation 1.053
|
—
|
—
|
|
Pre-dose Trough Concentration (Ctrough) of LJN452
Profile day 336
|
—
|
—
|
—
|
—
|
1.444 ng/mL
Standard Deviation 1.077
|
1.979 ng/mL
Standard Deviation 1.153
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 7 and 14 (10 and 30μg LJN452 C2h was not measured day 14)Population: FAS
Summary C2h of tropifexor (LJN452)
Outcome measures
| Measure |
LJN452 10 μg
n=14 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=16 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
n=85 Participants
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
C2h (Steady-state Drug Levels 2 Hours Postdose) of LJN452
Profile day 7
|
0.190 ng/mL
Standard Deviation 0.143
|
0.702 ng/mL
Standard Deviation 0.399
|
1.228 ng/mL
Standard Deviation 0.598
|
2.193 ng/mL
Standard Deviation 1.003
|
—
|
—
|
—
|
—
|
|
C2h (Steady-state Drug Levels 2 Hours Postdose) of LJN452
Profile day 14
|
—
|
—
|
1.344 ng/mL
Standard Deviation 0.727
|
2.001 ng/mL
Standard Deviation 1.053
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EoT (Week 48)Population: Full analysis set (FAS)
Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)
Outcome measures
| Measure |
LJN452 10 μg
n=39 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=35 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=42 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening of Steatohepatitis (Part C) - Total Score
|
11 Participants
|
11 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EoT (Week 48)Population: Full analysis set (FAS)
Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)
Outcome measures
| Measure |
LJN452 10 μg
n=38 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=35 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=42 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - FDA
|
11 Participants
|
11 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EoT (Week 48)Population: Full analysis set (FAS)
Number of patients who have at least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)
Outcome measures
| Measure |
LJN452 10 μg
n=38 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=35 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=42 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - EMA
|
11 Participants
|
11 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EoT (Week 48)Population: Full analysis set (FAS)
Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)
Outcome measures
| Measure |
LJN452 10 μg
n=38 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=35 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=42 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (Diagnostic Category)
|
4 Participants
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EoT (Week 48)Population: Full analysis set (FAS)
Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)
Outcome measures
| Measure |
LJN452 10 μg
n=38 Participants
10 micrograms of Tropifexor (Part A)
|
LJN452 30 μg
n=35 Participants
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=42 Participants
60 micrograms of Tropifexor (Parts A+B)
|
LJN452 90 μg
90 micrograms of Tropifexor (Parts A+B)
|
Placebo A+B
Placebo (Parts A+B)
|
LJN452 140 μg
140 micrograms of Tropifexor (Part C)
|
LNJ452 200 μg
200 micrograms of Tropifexor (Part C)
|
Placebo Part C
Placebo (Part C)
|
|---|---|---|---|---|---|---|---|---|
|
Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (FDA, EMA)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
LJN452 10 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LJN452 30 μg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LJN452 60 μg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
LJN452 90 μg
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
LJN452 140 μg
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
LJN452 200 μg
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
Total
Serious events: 18 serious events
Other events: 233 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LJN452 10 μg
n=13 participants at risk
LJN452 10 mcg (Part A)
|
LJN452 30 μg
n=17 participants at risk
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 participants at risk
LJN452 60 mcg (Parts A+B)
|
LJN452 90 μg
n=85 participants at risk
90 micrograms of Tropifexor (Parts A + B)
|
LJN452 140 μg
n=50 participants at risk
LJN452 140 mcg (Part C)
|
LJN452 200 μg
n=51 participants at risk
LJN452 200 mcg (Part C)
|
Placebo
n=97 participants at risk
Placebo A+B+C
|
Total
n=350 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.57%
2/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Product Issues
Device dislocation
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
Other adverse events
| Measure |
LJN452 10 μg
n=13 participants at risk
LJN452 10 mcg (Part A)
|
LJN452 30 μg
n=17 participants at risk
30 micrograms of Tropifexor (Part A)
|
LJN452 60 μg
n=37 participants at risk
LJN452 60 mcg (Parts A+B)
|
LJN452 90 μg
n=85 participants at risk
90 micrograms of Tropifexor (Parts A + B)
|
LJN452 140 μg
n=50 participants at risk
LJN452 140 mcg (Part C)
|
LJN452 200 μg
n=51 participants at risk
LJN452 200 mcg (Part C)
|
Placebo
n=97 participants at risk
Placebo A+B+C
|
Total
n=350 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Tonsillitis
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.57%
2/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.4%
2/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
9.4%
8/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
18.0%
9/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
10.3%
10/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
9.1%
32/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
18.0%
9/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.1%
3/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
14/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.4%
5/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.5%
3/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.1%
3/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.9%
10/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
8.0%
4/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
7.8%
4/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.4%
12/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
9.8%
5/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.7%
6/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.57%
2/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.86%
3/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.5%
3/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
10.0%
5/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.1%
4/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.3%
15/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
8.2%
8/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
14/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.57%
2/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
11.8%
2/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
12.0%
6/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.1%
3/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.3%
15/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.2%
5/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.3%
15/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.7%
4/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
13.7%
7/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.2%
6/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.3%
22/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.3%
8/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.7%
4/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.1%
4/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.7%
13/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
10.0%
5/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.9%
10/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
7/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.7%
4/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
12.0%
6/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
19.6%
10/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
11.3%
11/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
9.1%
32/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
11.8%
2/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.5%
3/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
7.8%
4/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
14/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
General disorders
Fatigue
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
17.6%
3/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
5/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
14.0%
7/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
9.3%
9/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
8.0%
28/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.7%
6/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Body tinea
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.86%
3/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.2%
6/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.9%
10/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
10.6%
9/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.1%
4/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.9%
17/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.4%
2/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
7.1%
6/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
12.0%
6/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
9.8%
5/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
10.3%
10/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
8.3%
29/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.57%
2/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.5%
3/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.4%
5/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
7.2%
7/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.1%
11/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
11.8%
2/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.6%
9/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
7/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.6%
9/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.1%
3/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.3%
8/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.5%
3/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
7.2%
7/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
14/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.86%
3/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.7%
4/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.0%
3/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
6.2%
6/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.4%
19/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.57%
2/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
8.0%
4/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.1%
2/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.1%
11/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.9%
2/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.0%
1/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.7%
6/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.2%
1/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
1/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.0%
7/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
17.6%
3/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
3.5%
3/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.3%
8/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
1/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
7.7%
1/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.29%
1/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
13.5%
5/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
8.2%
7/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
52.0%
26/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
68.6%
35/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
15.5%
15/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
25.1%
88/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.7%
1/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
2.4%
2/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
10.0%
5/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.9%
3/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.1%
4/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.3%
15/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/13 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/17 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
5.4%
2/37 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/85 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
4.0%
2/50 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/51 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
0.00%
0/97 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
1.1%
4/350 • To End of Treatment (EoT): For Parts A&B, EoT was Week 12; For Part C, EoT was Week 48
AEs are any untoward sign or symptom that occurred during the study treatment period 350 patients were randomized. One patient was treated at 2 sites, so 351 enrolled may appearr in some places.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER