Trial Outcomes & Findings for To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (NCT NCT04566666)
NCT ID: NCT04566666
Last Updated: 2026-01-20
Results Overview
The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
Week16
Results posted on
2026-01-20
Participant Flow
The Participant Flow is based on the safety population
Participant milestones
| Measure |
Part 1- Placebo of SCD-044 Product
Placebo of SCD-044 study drug
Placebo: Placebo of SCD-044 product
|
Part 1- SCD-044 Tablets_Low Dose (Dose 1)
SCD-044 tablets at Low Dose (Dose 1)
SCD-044\_Dose 1: SCD-044 tablets in Low Dose (Dose 1)
|
Part 1- SCD-044 Tablets_Intermediate Dose (Dose 2)
SCD-044 tablets at Intermediate Dose (Dose 2)
SCD-044\_Dose 2: SCD-044 tablets in Intermediate Dose (Dose 2)
|
Part 1- SCD-044 Tablets_High Dose (Dose 3)
SCD-044 tablets at High Dose (Dose 3)
SCD-044\_Dose 3: SCD-044 in High Dose (Dose 3)
|
Part 2- Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Part I (16 weeks)- Placebo; Part II (Week 16 to Week 28:)- Part I responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2)
|
Part 2- Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)
Part 1- Placebo Part 2- Part I responders will be re-randomized to SCD-044 tablets of high dose (Dose 3)
|
Part 2- Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of low dose (Dose 1)
|
Part 2- Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)
Part 1- SCD-044 tablets of intermediate dose (Dose 2) Part 2- Part I responders will remain on SCD-044 tablets of intermediate dose (Dose 2)
|
Part 2- Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3)
|
Part 2- Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2)
|
Part 2- Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3)
|
Part 2- Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3)
|
Part 2- Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Part 1- SCD-044 tablets of intermediate dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
64
|
71
|
69
|
59
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
49
|
59
|
57
|
46
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
15
|
12
|
12
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
9
|
12
|
32
|
36
|
45
|
10
|
15
|
25
|
21
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
11
|
30
|
33
|
20
|
7
|
8
|
20
|
15
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
3
|
25
|
3
|
7
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo of SCD-044 Product
n=64 Participants
Placebo: Placebo of SCD-044 product
|
SCD-044 Tablets_Dose 1
n=71 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=69 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=59 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 12.99 • n=37 Participants
|
44.8 years
STANDARD_DEVIATION 13.87 • n=44 Participants
|
46.3 years
STANDARD_DEVIATION 13.63 • n=40 Participants
|
46.3 years
STANDARD_DEVIATION 13.43 • n=121 Participants
|
46.2 years
STANDARD_DEVIATION 13.45 • n=84 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=37 Participants
|
27 Participants
n=44 Participants
|
24 Participants
n=40 Participants
|
27 Participants
n=121 Participants
|
100 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=37 Participants
|
44 Participants
n=44 Participants
|
45 Participants
n=40 Participants
|
32 Participants
n=121 Participants
|
163 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
1 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=121 Participants
|
12 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=37 Participants
|
60 Participants
n=44 Participants
|
61 Participants
n=40 Participants
|
52 Participants
n=121 Participants
|
234 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=37 Participants
|
8 Participants
n=44 Participants
|
6 Participants
n=40 Participants
|
1 Participants
n=121 Participants
|
15 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
1 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
43 Participants
n=37 Participants
|
31 Participants
n=44 Participants
|
31 Participants
n=40 Participants
|
42 Participants
n=121 Participants
|
147 Participants
n=84 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
21 Participants
n=37 Participants
|
40 Participants
n=44 Participants
|
38 Participants
n=40 Participants
|
17 Participants
n=121 Participants
|
116 Participants
n=84 Participants
|
PRIMARY outcome
Timeframe: Week16The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=60 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=61 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=48 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=50 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)
|
—
|
—
|
—
|
28.3 percentage of subjects
|
23.0 percentage of subjects
|
16.7 percentage of subjects
|
14.0 percentage of subjects
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 16. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=60 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=61 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=48 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=50 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) Score
|
—
|
—
|
—
|
10.0 percentage of subject
|
9.8 percentage of subject
|
8.3 percentage of subject
|
0 percentage of subject
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52The subjects achieving predefined improvement in Psoriasis Area and Severity Index (PASI) on a scale of 0-4 score. Higher score denotes more severe disease activity..
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=26 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
|
-11.62 score on a scale
Standard Deviation 6.010
|
—
|
—
|
-2.03 score on a scale
Standard Deviation 5.069
|
-17.18 score on a scale
Standard Deviation 7.685
|
-16.12 score on a scale
Standard Deviation 4.338
|
-3.58 score on a scale
Standard Deviation 1.813
|
-17.11 score on a scale
Standard Deviation 6.570
|
-9.30 score on a scale
Standard Deviation 2.970
|
-20.87 score on a scale
Standard Deviation 16.686
|
-10.58 score on a scale
Standard Deviation 5.401
|
SECONDARY outcome
Timeframe: Week 16Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 16. PASI50, PASI75, PASI90 and PASI100 are defined as 50%, 75%, 90% and 100% decrease from baseline in PASI correspondingly. The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=59 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=57 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=46 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=49 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 50
|
—
|
—
|
—
|
47.5 Percentage of subject
|
56.1 Percentage of subject
|
50.0 Percentage of subject
|
46.9 Percentage of subject
|
—
|
—
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 75
|
—
|
—
|
—
|
28.8 Percentage of subject
|
26.3 Percentage of subject
|
17.4 Percentage of subject
|
14.3 Percentage of subject
|
—
|
—
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 90
|
—
|
—
|
—
|
6.8 Percentage of subject
|
7.0 Percentage of subject
|
2.2 Percentage of subject
|
0 Percentage of subject
|
—
|
—
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 100
|
—
|
—
|
—
|
3.4 Percentage of subject
|
1.8 Percentage of subject
|
2.2 Percentage of subject
|
0 Percentage of subject
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 52 The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=26 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 50
|
100.0 percentage of subjects
|
—
|
—
|
66.7 percentage of subjects
|
88.5 percentage of subjects
|
92.6 percentage of subjects
|
66.7 percentage of subjects
|
95.0 percentage of subjects
|
50.0 percentage of subjects
|
100.0 percentage of subjects
|
88.9 percentage of subjects
|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 75
|
83.3 percentage of subjects
|
—
|
—
|
44.4 percentage of subjects
|
84.6 percentage of subjects
|
66.7 percentage of subjects
|
33.3 percentage of subjects
|
90.0 percentage of subjects
|
0 percentage of subjects
|
66.7 percentage of subjects
|
66.7 percentage of subjects
|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 90
|
16.7 percentage of subjects
|
—
|
—
|
11.1 percentage of subjects
|
46.2 percentage of subjects
|
33.3 percentage of subjects
|
16.7 percentage of subjects
|
55.0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Psoriasis Area and Severity Index (PASI) Response Rate
PASI 100
|
0 percentage of subjects
|
—
|
—
|
0 percentage of subjects
|
7.7 percentage of subjects
|
3.7 percentage of subjects
|
0 percentage of subjects
|
10.0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 16At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=59 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=57 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=46 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=49 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16
|
—
|
—
|
—
|
-23.2 score on a scale
Standard Deviation 28.42
|
-23.8 score on a scale
Standard Deviation 26.58
|
-23.6 score on a scale
Standard Deviation 28.69
|
-19.5 score on a scale
Standard Deviation 28.75
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=25 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52
|
-20.8 score on a scale
Standard Deviation 19.75
|
—
|
—
|
-9.6 score on a scale
Standard Deviation 17.21
|
-35.0 score on a scale
Standard Deviation 18.94
|
-33.6 score on a scale
Standard Deviation 25.03
|
-7.0 score on a scale
Standard Deviation 10.08
|
-55.7 score on a scale
Standard Deviation 20.87
|
-26.0 score on a scale
Standard Deviation 59.40
|
-24.0 score on a scale
Standard Deviation 23.07
|
-12.7 score on a scale
Standard Deviation 34.29
|
SECONDARY outcome
Timeframe: Week 16At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Total score range: 0-30 (higher = greater impact). Interpretation bands: 0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=59 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=57 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=46 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=49 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
|
—
|
—
|
—
|
-4.0 score on a scale
Standard Deviation 6.58
|
-4.6 score on a scale
Standard Deviation 6.50
|
-4.4 score on a scale
Standard Deviation 6.50
|
-5.0 score on a scale
Standard Deviation 7.00
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Total score range: 0-30 (higher = greater impact). Interpretation bands: 0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=25 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52
|
-4.2 score on a scale
Standard Deviation 4.54
|
—
|
—
|
-2.9 score on a scale
Standard Deviation 3.72
|
-7.8 score on a scale
Standard Deviation 5.28
|
-6.2 score on a scale
Standard Deviation 5.88
|
-1.5 score on a scale
Standard Deviation 1.22
|
-10.7 score on a scale
Standard Deviation 4.00
|
-2.5 score on a scale
Standard Deviation 4.95
|
-3.0 score on a scale
Standard Deviation 6.24
|
-4.6 score on a scale
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Week 52The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 52. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=26 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) Score
|
0 Percentage of participants
|
—
|
—
|
11.1 Percentage of participants
|
38.5 Percentage of participants
|
44.4 Percentage of participants
|
16.7 Percentage of participants
|
65.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
22.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=59 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=57 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=46 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=49 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 16
|
—
|
—
|
—
|
-8.32 % BSA
Standard Deviation 16.194
|
-9.57 % BSA
Standard Deviation 12.983
|
-9.63 % BSA
Standard Deviation 12.794
|
-7.21 % BSA
Standard Deviation 9.608
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=26 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 52
|
-15.17 % BSA
Standard Deviation 16.666
|
—
|
—
|
-11.01 % BSA
Standard Deviation 9.658
|
-21.60 % BSA
Standard Deviation 12.206
|
-21.77 % BSA
Standard Deviation 13.283
|
-7.17 % BSA
Standard Deviation 5.913
|
-26.03 % BSA
Standard Deviation 13.368
|
-12.50 % BSA
Standard Deviation 2.121
|
-25.67 % BSA
Standard Deviation 26.652
|
-19.00 % BSA
Standard Deviation 13.285
|
SECONDARY outcome
Timeframe: BaselineSubjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe (None- best outcome no symptoms; Severe- worst symptoms)
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=71 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=68 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=59 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=63 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Global Impression of Severity (PGIS)
None
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Severity (PGIS)
Mild
|
—
|
—
|
—
|
4 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Severity (PGIS)
Moderate
|
—
|
—
|
—
|
35 Participants
|
44 Participants
|
36 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Severity (PGIS)
Severe
|
—
|
—
|
—
|
32 Participants
|
22 Participants
|
21 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16At study weeks 0, 16, and 52, subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=59 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=57 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=46 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=49 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Global Impression of Severity (PGIS)
None
|
—
|
—
|
—
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Severity (PGIS)
Mild
|
—
|
—
|
—
|
20 Participants
|
26 Participants
|
14 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Severity (PGIS)
Moderate
|
—
|
—
|
—
|
29 Participants
|
21 Participants
|
25 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Severity (PGIS)
Severe
|
—
|
—
|
—
|
6 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=25 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Global Impression of Severity (PGIS)
None
|
0 Participants
|
—
|
—
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS)
Mild
|
5 Participants
|
—
|
—
|
4 Participants
|
15 Participants
|
15 Participants
|
6 Participants
|
12 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Patient Global Impression of Severity (PGIS)
Moderate
|
1 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS)
Severe
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52Subjects will be asked to assess if there has been a change in clinical status using a 5 point scale (1 to 5). 1 indicating 'Much better', while 5 indicating 'Much Worse'.
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=9 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=25 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
Much Better
|
2 participants
|
—
|
—
|
6 participants
|
15 participants
|
13 participants
|
5 participants
|
18 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Patient Global Impression of Change (PGIC)
A Little Better
|
3 participants
|
—
|
—
|
3 participants
|
5 participants
|
9 participants
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
5 participants
|
|
Patient Global Impression of Change (PGIC)
No Change
|
1 participants
|
—
|
—
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Patient Global Impression of Change (PGIC)
A Little Worse
|
0 participants
|
—
|
—
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Patient Global Impression of Change (PGIC)
Much Worse
|
0 participants
|
—
|
—
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 52Steady-state maximum plasma concentration (Cmax-ss)
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=6 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=8 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=24 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=27 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=6 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=18 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=2 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=3 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=9 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluate Pharmacokinetic Parameter
|
4197.117 pg/mL
Standard Deviation 4724.9842
|
—
|
—
|
1928.714 pg/mL
Standard Deviation 3388.7518
|
2528.022 pg/mL
Standard Deviation 2934.3946
|
3065.187 pg/mL
Standard Deviation 2612.9302
|
3242.187 pg/mL
Standard Deviation 3944.1894
|
3309.121 pg/mL
Standard Deviation 4368.2414
|
2831.310 pg/mL
Standard Deviation 4004.0770
|
5941.477 pg/mL
Standard Deviation 6859.1232
|
7264.772 pg/mL
Standard Deviation 6296.6163
|
SECONDARY outcome
Timeframe: Week 56Total Number Affected by adverse events from Baseline through Week 56
Outcome measures
| Measure |
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 Participants
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=20 Participants
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
n=16 Participants
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Tablets_Dose 1
n=71 Participants
SCD-044\_Dose 1: SCD-044 tablets in Dose 1.
|
SCD-044 Tablets_Dose 2
n=69 Participants
SCD-044\_Dose 2: SCD-044 tablets in Dose 2
|
SCD-044 Tablets_Dose 3
n=59 Participants
SCD-044\_Dose 3: SCD-044 in Dose 3
|
Placebo of SCD-044 Product
n=64 Participants
Placebo: Placebo of SCD-044 product
|
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=18 Participants
Part 1- SCD-044 tablets of high dose (Dose 3) Part 2- Part I responders will remain on SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)
n=22 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of intermediate dose (Dose 2) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)
n=32 Participants
Part 1- Placebo Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=36 Participants
Part 1- SCD-044 tablets of low dose (Dose 2) Part 2- Part I non-responders will be re-randomized to SCD-044 tablets of high dose (Dose 3) Part III (Week 28 to Week 52): Part II non-responder will be discontinued from the study and responders will continue their existing dosing regimen until the end of Part III.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Subjects With Adverse Events
Subjects with serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subjects With Adverse Events
Subjects with any TEAE
|
9 Participants
|
6 Participants
|
1 Participants
|
26 Participants
|
27 Participants
|
18 Participants
|
17 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
13 Participants
|
Adverse Events
Part 1- Placebo of SCD-044 Product
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 1- SCD-044 Tablets_Dose 1
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Part 1- SCD-044 Tablets_Dose 2
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Part 1- SCD-044 Tablets_Dose 3
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo to SCD-044 Intermediate Dose (Dose 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo to SCD-044 High Dose (Dose 3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1- Placebo of SCD-044 Product
n=64 participants at risk
Placebo tablet of SCD-044 product
|
Part 1- SCD-044 Tablets_Dose 1
n=71 participants at risk
SCD-044 Tablets of low dose (Dose 1)
|
Part 1- SCD-044 Tablets_Dose 2
n=69 participants at risk
SCD-044 Tablets of intermediate dose (Dose 2)
|
Part 1- SCD-044 Tablets_Dose 3
n=59 participants at risk
SCD-044 Tablets of high dose (Dose 3)
|
Placebo to SCD-044 Intermediate Dose (Dose 2)
n=18 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of intermediate dose in Part II
|
Placebo to SCD-044 High Dose (Dose 3)
n=22 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)
n=32 participants at risk
Subjects initially randomized to SCD-044 low dose continue the same treatment in part II
|
SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)
n=36 participants at risk
Subjects initially randomized to SCD-044 intermediate dose continue the same treatment in part II
|
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 participants at risk
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=20 participants at risk
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
n=16 participants at risk
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Cerebral artery embolism
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
Other adverse events
| Measure |
Part 1- Placebo of SCD-044 Product
n=64 participants at risk
Placebo tablet of SCD-044 product
|
Part 1- SCD-044 Tablets_Dose 1
n=71 participants at risk
SCD-044 Tablets of low dose (Dose 1)
|
Part 1- SCD-044 Tablets_Dose 2
n=69 participants at risk
SCD-044 Tablets of intermediate dose (Dose 2)
|
Part 1- SCD-044 Tablets_Dose 3
n=59 participants at risk
SCD-044 Tablets of high dose (Dose 3)
|
Placebo to SCD-044 Intermediate Dose (Dose 2)
n=18 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of intermediate dose in Part II
|
Placebo to SCD-044 High Dose (Dose 3)
n=22 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)
n=32 participants at risk
Subjects initially randomized to SCD-044 low dose continue the same treatment in part II
|
SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)
n=36 participants at risk
Subjects initially randomized to SCD-044 intermediate dose continue the same treatment in part II
|
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
n=20 participants at risk
Subjects initially randomized to SCD-044 high dose continue the same treatment in part II
|
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
n=20 participants at risk
Subjects initially randomized to low dose re-randomized to SCD-044 tablets of high dose in Part II
|
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
n=16 participants at risk
Subjects initially randomized to intermediate dose re-randomized to SCD-044 tablets of high dose in Part II
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/64 • 56 Weeks
|
7.0%
5/71 • 56 Weeks
|
2.9%
2/69 • 56 Weeks
|
3.4%
2/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
8.3%
3/36 • 56 Weeks
|
10.0%
2/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
1/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
10.0%
2/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
10.0%
2/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Aspartate aminotransferase decreased
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
1.6%
1/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Heart rate increased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
International normalised ratio increased
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Platelet count increased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Headache
|
7.8%
5/64 • 56 Weeks
|
5.6%
4/71 • 56 Weeks
|
2.9%
2/69 • 56 Weeks
|
5.1%
3/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
6.2%
2/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
20.0%
4/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • 56 Weeks
|
4.2%
3/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
3.4%
2/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Cerebral artery embolism
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
5.8%
4/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
—
0/0 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Vascular disorders
Hypertension
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
4.5%
1/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
6.2%
2/32 • 56 Weeks
|
5.6%
2/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Lyme disease
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
4.5%
1/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
6.2%
1/16 • 56 Weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
International normalised ratio abnormal
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Prothrombin time abnormal
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
5.6%
1/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Investigations
White blood cell count decreased
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
4.5%
1/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Congenital, familial and genetic disorders
Type V hyperlipidaemia
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Eye disorders
Macular oedema
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Eye disorders
Vision blurred
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Eye disorders
Myopia
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
4.3%
3/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
3.4%
2/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
4.3%
3/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
2.9%
2/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
3.4%
2/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
General disorders
Fatigue
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
2.9%
2/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
General disorders
Pyrexia
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
2.9%
2/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
4.5%
1/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
3/64 • 56 Weeks
|
8.5%
6/71 • 56 Weeks
|
2.9%
2/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
11.1%
2/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
6.2%
2/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/64 • 56 Weeks
|
2.8%
2/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
3.4%
2/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Abscess
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
COVID-19
|
3.1%
2/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
5.0%
1/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Influenza
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
6.2%
2/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Penile infection
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/64 • 56 Weeks
|
1.4%
1/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
3.1%
1/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
4.5%
1/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
2.8%
1/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
1.4%
1/69 • 56 Weeks
|
0.00%
0/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/64 • 56 Weeks
|
0.00%
0/71 • 56 Weeks
|
0.00%
0/69 • 56 Weeks
|
1.7%
1/59 • 56 Weeks
|
0.00%
0/18 • 56 Weeks
|
0.00%
0/22 • 56 Weeks
|
0.00%
0/32 • 56 Weeks
|
0.00%
0/36 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/20 • 56 Weeks
|
0.00%
0/16 • 56 Weeks
|
Additional Information
Head, Regulatory Affairs
Sun Pharmaceutical Industries Limited
Phone: 9122 66455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place