Trial Outcomes & Findings for Dose Range Study of CD5789 in Acne Vulgaris (NCT NCT01616654)
NCT ID: NCT01616654
Last Updated: 2021-09-20
Results Overview
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
From Baseline at Week 12
Results posted on
2021-09-20
Participant Flow
The study was conducted in United States. A total of 422 participants were screened between 20 June 2012 to 01 May 2013. Of which, 118 were screen failures. Screen failures were mainly due to inclusion criteria not met. A total of 304 participants were randomized in the study.
Participants randomized were stratified according to ethnic origin, acne severity \& number of lesions as: Stratum 1: Non-Japanese, Investigator's Global Assessment (IGA) of 3/4, \>= 20 but \<= 40 inflammatory and \>=30 non-inflammatory lesions and \<=1 nodule on face; Stratum 2: Non-Japanese, IGA of 4, \>40 inflammatory \& \>= 30 non-inflammatory lesions and \<=4 nodules on face; Stratum 3: Japanese origin, IGA of 3 or 4, \>= 20 inflammatory \& \>= 30 non-inflammatory lesions \& \<= 4 nodules on face.
Participant milestones
| Measure |
CD5789 25 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
Vehicle Cream
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
60
|
61
|
61
|
|
Overall Study
COMPLETED
|
56
|
53
|
50
|
53
|
49
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
10
|
8
|
12
|
Reasons for withdrawal
| Measure |
CD5789 25 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
Vehicle Cream
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
1
|
5
|
|
Overall Study
Protocol Violation
|
0
|
5
|
2
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
2
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Range Study of CD5789 in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
49 Participants
n=30 Participants
|
|
Age, Continuous
|
18.1 years
STANDARD_DEVIATION 5.26 • n=99 Participants
|
18.2 years
STANDARD_DEVIATION 4.76 • n=107 Participants
|
18.3 years
STANDARD_DEVIATION 5.59 • n=206 Participants
|
18.3 years
STANDARD_DEVIATION 4.83 • n=7 Participants
|
18.3 years
STANDARD_DEVIATION 4.84 • n=31 Participants
|
18.2 years
STANDARD_DEVIATION 5.03 • n=30 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
65 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
239 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
249 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From Baseline at Week 12Population: Analysis was performed on Intent to treat (ITT) population that included all subjects who were randomized and to whom study drug was dispensed.
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Outcome measures
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Success Rate 1 (SR1)
|
29.51 percentage of participants
|
32.79 percentage of participants
|
26.67 percentage of participants
|
32.79 percentage of participants
|
16.39 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population.
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Outcome measures
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
|
-53.61 lesion count
Standard Error 8.314
|
-54.75 lesion count
Standard Error 8.261
|
-54.99 lesion count
Standard Error 8.296
|
-59.84 lesion count
Standard Error 8.301
|
-46.87 lesion count
Standard Error 7.934
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population.
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Outcome measures
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
|
-47.59 percentage change
Standard Deviation 28.474
|
-49.87 percentage change
Standard Deviation 24.731
|
-50.72 percentage change
Standard Deviation 24.885
|
-55.07 percentage change
Standard Deviation 26.295
|
-40.48 percentage change
Standard Deviation 28.968
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Analysis was performed on ITT population.
Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to Week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by LOCF.
Outcome measures
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Success Rate 2 (SR2)
|
13.11 percentage of participants
|
14.75 percentage of participants
|
16.67 percentage of participants
|
21.31 percentage of participants
|
8.20 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population.
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.
Outcome measures
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Inflammatory Lesions
|
-19.67 lesion count
Standard Deviation 14.874
|
-21.11 lesion count
Standard Deviation 13.268
|
-19.32 lesion count
Standard Deviation 11.566
|
-21.03 lesion count
Standard Deviation 13.890
|
-17.74 lesion count
Standard Deviation 15.073
|
|
Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Non-inflammatory Lesions
|
-24.30 lesion count
Standard Deviation 21.633
|
-18.69 lesion count
Standard Deviation 12.895
|
-23.70 lesion count
Standard Deviation 18.390
|
-28.26 lesion count
Standard Deviation 26.346
|
-17.70 lesion count
Standard Deviation 17.745
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on ITT population.
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF. Percent changes in lesion counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100.
Outcome measures
| Measure |
CD5789 25 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 Participants
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 Participants
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 Participants
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Inflammatory lesion count
|
-49.16 percentage change
Standard Deviation 35.711
|
-53.14 percentage change
Standard Deviation 30.187
|
-51.93 percentage change
Standard Deviation 27.255
|
-53.09 percentage change
Standard Deviation 29.484
|
-41.70 percentage change
Standard Deviation 35.898
|
|
Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Non-inflammatory lesion count
|
-46.34 percentage change
Standard Deviation 30.888
|
-45.26 percentage change
Standard Deviation 29.331
|
-49.57 percentage change
Standard Deviation 29.786
|
-55.88 percentage change
Standard Deviation 28.913
|
-38.20 percentage change
Standard Deviation 30.368
|
Adverse Events
CD5789 25 mcg/g Cream
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
CD5789 50 mcg/g Cream
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
CD5789 100 mcg/g Cream
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Tazarotene 0.1% Gel
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
CD5789 Vehicle Cream
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD5789 25 mcg/g Cream
n=61 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 participants at risk
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Psychiatric disorders
Depression
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
Other adverse events
| Measure |
CD5789 25 mcg/g Cream
n=61 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
CD5789 50 mcg/g Cream
n=61 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
|
CD5789 100 mcg/g Cream
n=60 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
|
Tazarotene 0.1% Gel
n=61 participants at risk
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
|
CD5789 Vehicle Cream
n=61 participants at risk
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Wound
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Blood glucose increased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Electrocardiogram ST segment elevation
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
General disorders
Pain
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Immune system disorders
Allergy to arthropod bite
|
1.6%
1/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
4/61 • Number of events 4 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
8.3%
5/60 • Number of events 5 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
8.2%
5/61 • Number of events 5 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
4.9%
3/61 • Number of events 3 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
6.7%
4/60 • Number of events 4 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
9.8%
6/61 • Number of events 6 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Influenza
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/60 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Furuncle
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Streptococcal infection
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
10.0%
6/60 • Number of events 7 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
8.2%
5/61 • Number of events 5 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/60 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Eye disorders
Eye haemorrhage
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Nervous system disorders
Headache
|
3.3%
2/61 • Number of events 3 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
4.9%
3/61 • Number of events 3 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
3.3%
2/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
General disorders
Pyrexia
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.7%
1/60 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Psychiatric disorders
Depression
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Vascular disorders
Hypertension
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 2 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/60 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
1.6%
1/61 • Number of events 1 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
0.00%
0/61 • Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide his draft of such publication to sponsor to review and approve at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
- Publication restrictions are in place
Restriction type: OTHER