Trial Outcomes & Findings for Safety and Efficacy of Oral Etrasimod in Adult Participants With Moderate-to-Severe Alopecia Areata (NCT NCT04556734)
NCT ID: NCT04556734
Last Updated: 2024-06-26
Results Overview
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
DB Treatment Period: Baseline (before dose on Day 1), Week 24
Results posted on
2024-06-26
Participant Flow
The study consisted of a double-blind (DB) treatment period (24 weeks) followed by an open label extension (OLE) period (28 weeks). A total of 80 participants with moderate-to-severe alopecia areata (AA) were enrolled in the DB treatment period of the study. Out of 80 participants, 65 participants entered in the subsequent OLE period.
Participant milestones
| Measure |
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|---|---|---|
|
DB Treatment Period (24 Weeks)
STARTED
|
31
|
25
|
24
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
Treated
|
31
|
25
|
23
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
COMPLETED
|
24
|
24
|
17
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
NOT COMPLETED
|
7
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (28 Weeks)
STARTED
|
0
|
0
|
0
|
4
|
4
|
24
|
20
|
13
|
|
OLE Period (28 Weeks)
Treated
|
0
|
0
|
0
|
4
|
4
|
24
|
20
|
13
|
|
OLE Period (28 Weeks)
COMPLETED
|
0
|
0
|
0
|
2
|
1
|
21
|
19
|
9
|
|
OLE Period (28 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
2
|
3
|
3
|
1
|
4
|
Reasons for withdrawal
| Measure |
DB Treatment Period: Etrasimod 2 mg
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|---|---|---|
|
DB Treatment Period (24 Weeks)
Withdrawal by Subject
|
4
|
1
|
5
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DB Treatment Period (24 Weeks)
Randomized but not treated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period (28 Weeks)
Not reported
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
OLE Period (28 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
OLE Period (28 Weeks)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
|
OLE Period (28 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
3
|
2
|
1
|
0
|
Baseline Characteristics
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
Baseline characteristics by cohort
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=31 Participants
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=25 Participants
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=24 Participants
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
n=4 Participants
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
n=4 Participants
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
n=24 Participants
Participants who received etrasimod 3 mg (also included participants whose dose was reduced from 3 mg to 2 mg due to safety issue) in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
n=20 Participants
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
n=13 Participants
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg orally once daily in OLE period either from Week 25 to Week 52 (participants who entered OLE phase on or after protocol amendment 2.0 and 2.1) or beginning after Week 25 to Week 52 in OLE period (participants who entered OLE before protocol amendment 2.0 and 2.1). Participants were followed up for up to 4 weeks after last dose of study drug.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
DB Treatment Period · Unknown or Not Reported
|
2 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Age, Continuous
DB Treatment Period
|
36.6 Years
STANDARD_DEVIATION 12.60 • n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
41.7 Years
STANDARD_DEVIATION 16.63 • n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
43.4 Years
STANDARD_DEVIATION 13.25 • n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
—
|
—
|
—
|
—
|
—
|
40.4 Years
STANDARD_DEVIATION 14.33 • n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Age, Continuous
OLE Period
|
—
|
—
|
—
|
38.0 Years
STANDARD_DEVIATION 14.99 • n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
43.5 Years
STANDARD_DEVIATION 15.67 • n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
42.4 Years
STANDARD_DEVIATION 16.65 • n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
35.1 Years
STANDARD_DEVIATION 12.17 • n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
44.8 Years
STANDARD_DEVIATION 11.53 • n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
40.4 Years
STANDARD_DEVIATION 14.35 • n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Sex: Female, Male
DB Treatment Period · Female
|
16 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
21 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
22 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
59 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Sex: Female, Male
DB Treatment Period · Male
|
15 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
21 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Sex: Female, Male
OLE Period · Female
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
20 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
9 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
13 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
46 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Sex: Female, Male
OLE Period · Male
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
11 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
19 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Ethnicity (NIH/OMB)
DB Treatment Period · Hispanic or Latino
|
4 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
10 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Ethnicity (NIH/OMB)
DB Treatment Period · Not Hispanic or Latino
|
25 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
21 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
20 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
66 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Ethnicity (NIH/OMB)
OLE Period · Hispanic or Latino
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
7 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Ethnicity (NIH/OMB)
OLE Period · Not Hispanic or Latino
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
21 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
14 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
12 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
55 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Ethnicity (NIH/OMB)
OLE Period · Unknown or Not Reported
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · American Indian or Alaska Native
|
1 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · Asian
|
1 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · Black or African American
|
2 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
6 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
11 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · White
|
25 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
16 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
17 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
58 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · More than one race
|
2 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
DB Treatment Period · Unknown or Not Reported
|
0 Participants
n=31 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=25 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=80 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · American Indian or Alaska Native
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · Asian
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · Native Hawaiian or Other Pacific Islander
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · Black or African American
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
4 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
10 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · White
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
15 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
16 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
9 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
44 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · More than one race
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
1 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
3 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
|
Race (NIH/OMB)
OLE Period · Unknown or Not Reported
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=4 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=24 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=20 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
0 Participants
n=13 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
2 Participants
n=65 Participants • Number Analyzed for DB treatment period and OLE Period = number of participants analyzed for reporting arms for respective period. Participants in DB treatment period and OLE period are not exclusive.
|
PRIMARY outcome
Timeframe: DB Treatment Period: Baseline (before dose on Day 1), Week 24Population: DB treatment period's full analysis set (FAS) included all randomized participants with a SALT I less than (\<) 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.
Outcome measures
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=16 Participants
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=24 Participants
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=13 Participants
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Severity of Alopecia Tool I (SALT I) at Week 24: DB Treatment Period
|
-13.79 Percent change of scalp surface area
Standard Error 8.557
|
-21.43 Percent change of scalp surface area
Standard Error 6.926
|
0.35 Percent change of scalp surface area
Standard Error 8.933
|
—
|
—
|
SECONDARY outcome
Timeframe: DBT Period: Baseline, Week 24Population: DB treatment period's FAS included all randomized participants with a SALT I \<95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Here, " Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Change from baseline in SALT I is reported in terms of Least square mean and standard error.
Outcome measures
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=16 Participants
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=24 Participants
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=13 Participants
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|
|
Change From Baseline in SALT I at Week 24: DB Treatment Period
|
-8.87 % of scalp surface area
Standard Error 4.142
|
-8.62 % of scalp surface area
Standard Error 3.351
|
0.36 % of scalp surface area
Standard Error 4.314
|
—
|
—
|
SECONDARY outcome
Timeframe: DB Treatment Period: Baseline, Week 24Population: DB treatment period's FAS included all randomized participants with a SALT I \< 95 at baseline who received at least one dose of study drug in DB treatment period. Participants were analyzed according to the treatment they received. Missing data for any reason was imputed as per the non-responder imputation (NRI) method.
SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage of scalp surface area involved on the top, back, and each side of the scalp for alopecia areata (AA). Investigator determine the percent scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total percent scalp hair loss with a maximum score of 100. Score range from 0 to 100, where 0 =no scalp hair loss to 100 = complete scalp hair loss, higher scores indicated more scalp hair loss. Percentage of participants who achieved \>=30%, \>=50%, \>=75% improvement from baseline in SALT I at Week 24 was reported in this outcome measure.
Outcome measures
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=17 Participants
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=25 Participants
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=16 Participants
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
>= 30% Improvement
|
23.5 Percentage of participants
Interval 6.81 to 49.9
|
36.0 Percentage of participants
Interval 17.97 to 57.48
|
12.5 Percentage of participants
Interval 1.55 to 38.35
|
—
|
—
|
|
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
>= 50% Improvement
|
11.8 Percentage of participants
Interval 1.46 to 36.44
|
28.0 Percentage of participants
Interval 12.07 to 49.39
|
12.5 Percentage of participants
Interval 1.55 to 38.35
|
—
|
—
|
|
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 30%, >= 50% and >=75% Improvement From Baseline in SALT I at Week 24: DB Treatment Period
>= 75% Improvement
|
5.9 Percentage of participants
Interval 0.15 to 28.69
|
12.0 Percentage of participants
Interval 2.55 to 31.22
|
0.000 Percentage of participants
Interval 0.0 to 20.59
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: DB Treatment Period: From first dosing date in DB up to (before the first dosing date in OLE) or (last dosing date + 4 weeks + 3 days), whichever is earlier (maximum up to 29 weeks)Population: DB treatment period's SAF included of all randomized participants who received at least 1 dose of study drug in DBT period. Participants were analyzed according to the treatment they received.
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of progressive multifocal leukoencephalopathy (PML). AEs included serious AEs and all non-SAEs.
Outcome measures
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=31 Participants
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=25 Participants
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=23 Participants
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE): DB Treatment Period
|
21 Participants
|
20 Participants
|
18 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: OLE period: From first dosing date in OLE up to last dosing date + 4 weeks + 3 days (maximum up to 33 weeks)Population: OLE period's SAF included of all participants who received at least 1 dose of study drug in the OLE Period. Participants were analyzed according to the treatment they received.
An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations based on medical significance or any diagnosis of PML. AEs included serious AEs and all non-SAEs.
Outcome measures
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=4 Participants
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=4 Participants
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=24 Participants
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
n=20 Participants
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
n=13 Participants
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events: OLE Period
|
3 Participants
|
2 Participants
|
18 Participants
|
14 Participants
|
11 Participants
|
Adverse Events
DB Treatment Period: Etrasimod 2 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
DB Treatment Period: Etrasimod 3 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DB Treatment Period: Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=31 participants at risk
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=25 participants at risk
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=23 participants at risk
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
n=4 participants at risk
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
n=4 participants at risk
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
n=24 participants at risk
Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
n=20 participants at risk
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
n=13 participants at risk
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
Other adverse events
| Measure |
DB Treatment Period: Etrasimod 2 mg
n=31 participants at risk
Participants who were randomized to receive etrasimod 2 milligram (mg) orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Etrasimod 3 mg
n=25 participants at risk
Participants who were randomized to receive etrasimod 2 mg orally once daily initially for Week 1 and then etrasimod 3 mg orally once daily for rest of the 23 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
DB Treatment Period: Placebo
n=23 participants at risk
Participants who were randomized to receive placebo matched to etrasimod orally once daily for 24 weeks in DB treatment period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Etrasimod 2 mg in DB Treatment Period]
n=4 participants at risk
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 2 mg [Placebo in DB Treatment Period]
n=4 participants at risk
Participants who received placebo matched to etrasimod in DB treatment period, received etrasimod 2 mg orally once daily in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 3 mg in DB Treatment Period]
n=24 participants at risk
Participants who received etrasimod 3 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period. Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Etrasimod 2 mg in DB Treatment Period]
n=20 participants at risk
Participants who received etrasimod 2 mg in DB treatment period, received etrasimod 3 mg orally once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
OLE Period: Etrasimod 3 mg [Placebo in DB Treatment Period]
n=13 participants at risk
Participants received placebo matched to etrasimod in DB treatment period, received etrasimod 3 mg once daily either from Week 25 to Week 52 or beginning after Week 25 to Week 52 in OLE period.Participants were followed up for up to 4 weeks after last dose of study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.0%
1/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.3%
1/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Infections and infestations
COVID-19
|
3.2%
1/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.0%
2/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
13.0%
3/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.0%
1/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
13.0%
3/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.3%
2/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
10.0%
2/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
23.1%
3/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
12.0%
3/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.3%
1/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.3%
2/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.7%
2/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.7%
2/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Investigations
Gamma-glutamyl transferase increased
|
6.5%
2/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.0%
2/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.3%
1/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
10.0%
2/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.0%
1/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.3%
1/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
3/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.0%
1/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.3%
1/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.7%
2/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.0%
2/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.0%
2/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
17.4%
4/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.0%
2/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.3%
1/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
10.0%
2/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Eye disorders
Eye pain
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Eye disorders
Fuchs' syndrome
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
12.5%
3/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
4.2%
1/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
General disorders
Fatigue
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
General disorders
Influenza like illness
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
General disorders
Malaise
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
General disorders
Nodule
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.3%
2/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
15.0%
3/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
10.0%
2/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
20.8%
5/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Investigations
Blood pressure increased
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Nervous system disorders
Migraine
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
15.4%
2/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Nervous system disorders
Retinal migraine
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
5.0%
1/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
7.7%
1/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
12.5%
3/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.3%
2/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
25.0%
1/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/31 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/25 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/23 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/4 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
8.3%
2/24 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/20 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
0.00%
0/13 • From first dosing date up to last dosing date + 4 weeks + 3 days (maximum up to 57 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set was evaluated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER