Trial Outcomes & Findings for To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (NCT NCT04684485)
NCT ID: NCT04684485
Last Updated: 2025-12-30
Results Overview
Based on gross morphological findings, scores will be assigned on a 4-point scale \['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)\] for each clinical sign. 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
250 participants
Primary outcome timeframe
Week16
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
Part 1- Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo:Placebo Tabletof SCD-044product in subjects with moderate to severe atopic dermatitis
|
Part 1 - SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 1 - SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 3: SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2- Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week16
|
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose(Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediatedose (Dose 2) in subjects with moderate to severe atopicdermatitis
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo of SCD-044 Product
n=61 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=72 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Intermediate Dose (Dose 2)
n=64 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of High Dose (Dose 3)
n=53 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 3: SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 15.61 • n=174 Participants
|
39.5 years
STANDARD_DEVIATION 12.42 • n=166 Participants
|
40.4 years
STANDARD_DEVIATION 15.10 • n=167 Participants
|
39.5 years
STANDARD_DEVIATION 13.84 • n=164 Participants
|
40.6 years
STANDARD_DEVIATION 14.22 • n=671 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=174 Participants
|
48 Participants
n=166 Participants
|
40 Participants
n=167 Participants
|
35 Participants
n=164 Participants
|
162 Participants
n=671 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=174 Participants
|
24 Participants
n=166 Participants
|
24 Participants
n=167 Participants
|
18 Participants
n=164 Participants
|
88 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=174 Participants
|
36 Participants
n=166 Participants
|
35 Participants
n=167 Participants
|
35 Participants
n=164 Participants
|
148 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=174 Participants
|
36 Participants
n=166 Participants
|
29 Participants
n=167 Participants
|
18 Participants
n=164 Participants
|
102 Participants
n=671 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
4 Participants
n=164 Participants
|
10 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=174 Participants
|
4 Participants
n=166 Participants
|
4 Participants
n=167 Participants
|
8 Participants
n=164 Participants
|
22 Participants
n=671 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=174 Participants
|
59 Participants
n=166 Participants
|
52 Participants
n=167 Participants
|
38 Participants
n=164 Participants
|
199 Participants
n=671 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
4 Participants
n=167 Participants
|
3 Participants
n=164 Participants
|
16 Participants
n=671 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
2 Participants
n=671 Participants
|
PRIMARY outcome
Timeframe: Week16Based on gross morphological findings, scores will be assigned on a 4-point scale \['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)\] for each clinical sign. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=64 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=53 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=61 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=72 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.
|
—
|
—
|
—
|
—
|
12.5 percentage of subjects
|
15.1 percentage of subjects
|
—
|
9.8 percentage of subjects
|
18.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 16Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' \[clear\] to 4 \[severe\]). The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=64 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=53 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=61 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=72 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16.
|
—
|
—
|
—
|
—
|
12.5 percentage of subject
|
9.4 percentage of subject
|
—
|
6.6 percentage of subject
|
9.7 percentage of subject
|
SECONDARY outcome
Timeframe: Week 32Based on gross morphological findings, scores will be assigned on a 4-point scale \['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)\] for each clinical sign.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=48 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=43 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Mean Eczema Area and Severity Index (EASI) Score
|
—
|
—
|
—
|
—
|
-64.77 Percent change
Standard Deviation 26.289
|
-67.04 Percent change
Standard Deviation 23.679
|
-54.40 Percent change
Standard Deviation 44.901
|
-16.61 Percent change
Standard Deviation 68.985
|
6.78 Percent change
Standard Deviation 199.014
|
SECONDARY outcome
Timeframe: Week 32Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' \[clear\] to 4 \[severe\]). The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=48 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=43 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline.
|
—
|
—
|
—
|
—
|
20.8 percentage of subject
|
27.5 percentage of subject
|
25.6 percentage of subject
|
11.1 percentage of subject
|
4.3 percentage of subject
|
SECONDARY outcome
Timeframe: Week 32The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=45 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=38 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=42 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=16 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=22 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.
|
—
|
—
|
—
|
—
|
55.6 percentage of subjects
|
57.9 percentage of subjects
|
50.0 percentage of subjects
|
6.3 percentage of subjects
|
4.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 32The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=47 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=42 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32
SCORAD 50
|
—
|
—
|
—
|
—
|
51.1 percentage of subjects
|
47.5 percentage of subjects
|
50.0 percentage of subjects
|
16.7 percentage of subjects
|
17.4 percentage of subjects
|
|
Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32
SCORAD 75
|
—
|
—
|
—
|
—
|
8.5 percentage of subjects
|
17.5 percentage of subjects
|
16.7 percentage of subjects
|
5.6 percentage of subjects
|
4.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 32Based on 10-item questionnaire on skin problems (0 to 3 scale). 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. The scoring of each question is as follows: 3=Very much; 2= A lot; 1= A little; 0= Not at all
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=47 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=42 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.
|
—
|
—
|
—
|
—
|
-6.7 score on a scale
Standard Deviation 5.93
|
-6.5 score on a scale
Standard Deviation 7.49
|
-7.3 score on a scale
Standard Deviation 6.22
|
-3.9 score on a scale
Standard Deviation 4.23
|
-2.2 score on a scale
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: Week 32Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=48 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=43 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
|
—
|
—
|
—
|
—
|
-50.14 percent change
Standard Deviation 33.095
|
-53.61 percent change
Standard Deviation 25.314
|
-43.97 percent change
Standard Deviation 51.922
|
-19.56 percent change
Standard Deviation 21.288
|
-6.61 percent change
Standard Deviation 95.403
|
SECONDARY outcome
Timeframe: Week 32Subjects will be asked to complete a 7-item questionnaire about their atopic dermatitis over the past week. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows 4= Every day; 3= 5-6 days; 2= 3-4 days; 1= 1-2 days; 0= No days The POEM scores can be understood as follows: 0 to 2= Clear or almost clear 3 to 7= Mild eczema 8 to 16= Moderate eczema 17 to 24= Severe eczema 25 to 28= Very severe eczema The higher the score, the more quality of life is impaired.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=48 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=42 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
|
—
|
—
|
—
|
—
|
-8.4 score on a scale
Standard Deviation 6.23
|
-8.8 score on a scale
Standard Deviation 5.93
|
-8.4 score on a scale
Standard Deviation 6.00
|
-2.1 score on a scale
Standard Deviation 7.22
|
-1.3 score on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Week 32The subjects will be asked to assess if there has been an improvement or decline in clinical status using a 5-point scale depicting a subject's rating of overall improvement. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=48 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=43 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score
|
—
|
—
|
—
|
—
|
85.4 percentage of participants
|
90.0 percentage of participants
|
88.4 percentage of participants
|
88.9 percentage of participants
|
95.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 32The subjects will be asked to assess their overall impression of disease severity over the past week using a scale of None, Mild, Moderate or Severe.
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=48 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=40 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=43 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=18 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=23 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Global Impression of Severity (PGIS) of Disease Score
Moderate
|
—
|
—
|
—
|
—
|
16 Participants
|
12 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS) of Disease Score
Severe
|
—
|
—
|
—
|
—
|
4 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS) of Disease Score
None
|
—
|
—
|
—
|
—
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS) of Disease Score
Mild
|
—
|
—
|
—
|
—
|
25 Participants
|
18 Participants
|
22 Participants
|
7 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 36Total Number Affected by adverse events from Baseline through Week 36
Outcome measures
| Measure |
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
n=26 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
n=58 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=49 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
n=45 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=64 Participants
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=53 Participants
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=25 Participants
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
|
Placebo of SCD-044 Product
n=61 Participants
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
|
SCD-044 Tablets of Low Dose (Dose 1)
n=72 Participants
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044\_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events.
Subjects with any TEAE
|
5 Participants
|
13 Participants
|
17 Participants
|
11 Participants
|
18 Participants
|
18 Participants
|
4 Participants
|
13 Participants
|
23 Participants
|
|
Adverse Events.
Subjects with serious TEAE
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2- SCD-044 Tablets of High Dose (Dose 3)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1-Placebo of SCD-044 Product
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1- SCD-044 Tablets of Low Dose (Dose 1)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part 1- SCD-044 Tablets of High Dose (Dose 3)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=25 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets Dose 2 (Intermediate Dose) at week 16
|
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
n=26 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
n=58 participants at risk
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=49 participants at risk
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
n=45 participants at risk
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1-Placebo of SCD-044 Product
n=61 participants at risk
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis
|
Part 1- SCD-044 Tablets of Low Dose (Dose 1)
n=72 participants at risk
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=64 participants at risk
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=53 participants at risk
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
Other adverse events
| Measure |
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
n=25 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets Dose 2 (Intermediate Dose) at week 16
|
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
n=26 participants at risk
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
|
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
n=58 participants at risk
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=49 participants at risk
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 2- SCD-044 Tablets of High Dose (Dose 3)
n=45 participants at risk
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
Part 1-Placebo of SCD-044 Product
n=61 participants at risk
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis
|
Part 1- SCD-044 Tablets of Low Dose (Dose 1)
n=72 participants at risk
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
n=64 participants at risk
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
|
Part 1- SCD-044 Tablets of High Dose (Dose 3)
n=53 participants at risk
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Visual field defect
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Eye swelling
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Vision blurred
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Eye disorders
Astigmatism
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Blepharitis allergic
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
5.6%
4/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
5.7%
3/53 • 36 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
3.1%
2/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
General disorders
Asthenia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
2.8%
2/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
General disorders
Chills
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
General disorders
Pyrexia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
3.4%
2/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
General disorders
Fatigue
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
3.1%
2/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
8.6%
5/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
4.4%
2/45 • 36 Weeks
|
4.9%
3/61 • 36 Weeks
|
5.6%
4/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
3.8%
2/53 • 36 Weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
3.4%
2/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
4.2%
3/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
2.8%
2/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
3.8%
2/53 • 36 Weeks
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
3.4%
2/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Investigations
Blood glucose increased
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
White blood cell count decreased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
3.3%
2/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Eosinophil count decreased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Lipids increased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Heart rate increased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
2.8%
2/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
8.6%
5/58 • 36 Weeks
|
4.1%
2/49 • 36 Weeks
|
4.4%
2/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
9.7%
7/72 • 36 Weeks
|
3.1%
2/64 • 36 Weeks
|
5.7%
3/53 • 36 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Renal and urinary disorders
Urinary tract inflammation
|
4.0%
1/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
2.0%
1/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
3.4%
2/58 • 36 Weeks
|
6.1%
3/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
5.6%
4/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/25 • 36 Weeks
|
3.8%
1/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
2.2%
1/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
1.6%
1/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
1.6%
1/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
1.7%
1/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
1.4%
1/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
0.00%
0/53 • 36 Weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/25 • 36 Weeks
|
0.00%
0/26 • 36 Weeks
|
0.00%
0/58 • 36 Weeks
|
0.00%
0/49 • 36 Weeks
|
0.00%
0/45 • 36 Weeks
|
0.00%
0/61 • 36 Weeks
|
0.00%
0/72 • 36 Weeks
|
0.00%
0/64 • 36 Weeks
|
1.9%
1/53 • 36 Weeks
|
Additional Information
Head Regulatory Affairs
Sun Pharmaceutical Industries Limited
Phone: 2266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place