Trial Outcomes & Findings for Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris (NCT NCT02616614)
NCT ID: NCT02616614
Last Updated: 2020-05-27
Results Overview
Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
862 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-05-27
Participant Flow
The populations for this study included the Safety Population, the Per-Protocol Population (PP), and the modified Intent-to-Treat (mITT) Population.
Participant milestones
| Measure |
Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel)
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Vehicle Gel
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
347
|
345
|
170
|
|
Overall Study
Safety Population
|
329
|
328
|
161
|
|
Overall Study
mITT Population
|
325
|
325
|
160
|
|
Overall Study
PP Population
|
253
|
255
|
122
|
|
Overall Study
COMPLETED
|
282
|
285
|
141
|
|
Overall Study
NOT COMPLETED
|
65
|
60
|
29
|
Reasons for withdrawal
| Measure |
Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel)
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Vehicle Gel
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
6
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
4
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
1
|
|
Overall Study
Prohibited Medication
|
12
|
9
|
5
|
|
Overall Study
More than 3 applications missed
|
6
|
8
|
1
|
|
Overall Study
Lost to Follow-up
|
31
|
28
|
13
|
|
Overall Study
Pregnancy
|
2
|
0
|
1
|
|
Overall Study
Other
|
1
|
2
|
1
|
Baseline Characteristics
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel
n=329 Participants
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75)
n=328 Participants
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Vehicle Gel
n=161 Participants
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Total
n=818 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.6 years
STANDARD_DEVIATION 7.56 • n=93 Participants
|
20.4 years
STANDARD_DEVIATION 7.04 • n=4 Participants
|
20.1 years
STANDARD_DEVIATION 6.92 • n=27 Participants
|
20.4 years
STANDARD_DEVIATION 7.23 • n=483 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=93 Participants
|
217 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
526 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
292 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
76 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
210 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
253 Participants
n=93 Participants
|
239 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
608 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
210 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
225 Participants
n=93 Participants
|
224 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
559 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Using the per-protocol population.
Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population.
Outcome measures
| Measure |
Generic Clindamycin and Benzoyl Peroxide
n=253 Participants
Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC)
|
Reference Onexton (Clindamycin and Benzoyl Peroxide)
n=255 Participants
Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC)
|
Vehicle Gel
n=122 Participants
Vehicle Gel: Placebo product
|
|---|---|---|---|
|
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
|
-63.81 percentage of change
Standard Deviation 36.791
|
-67.56 percentage of change
Standard Deviation 28.405
|
-53.78 percentage of change
Standard Deviation 40.138
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Using the per-protocol population.
One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population.
Outcome measures
| Measure |
Generic Clindamycin and Benzoyl Peroxide
n=253 Participants
Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC)
|
Reference Onexton (Clindamycin and Benzoyl Peroxide)
n=255 Participants
Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC)
|
Vehicle Gel
n=122 Participants
Vehicle Gel: Placebo product
|
|---|---|---|---|
|
Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts
|
-49.58 percentage of change
Standard Deviation 40.747
|
-49.50 percentage of change
Standard Deviation 32.872
|
-37.50 percentage of change
Standard Deviation 40.261
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Using the PP population.
The secondary efficacy endpoint was the IGA score, expressed in terms of proportion of subjects with treatment success or failure at Week 12, where "success" was defined as an IGA score that was at least 2 grades less than the baseline assessment.
Outcome measures
| Measure |
Generic Clindamycin and Benzoyl Peroxide
n=253 Participants
Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC)
|
Reference Onexton (Clindamycin and Benzoyl Peroxide)
n=255 Participants
Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC)
|
Vehicle Gel
n=122 Participants
Vehicle Gel: Placebo product
|
|---|---|---|---|
|
Number of Subjects With Treatment Success at Week 12
Success
|
54 participants
|
60 participants
|
13 participants
|
|
Number of Subjects With Treatment Success at Week 12
Failure
|
199 participants
|
195 participants
|
109 participants
|
Adverse Events
Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel
Serious events: 4 serious events
Other events: 197 other events
Deaths: 0 deaths
Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75)
Serious events: 0 serious events
Other events: 211 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel
n=329 participants at risk
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75)
n=328 participants at risk
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Vehicle Gel
n=161 participants at risk
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
|---|---|---|---|
|
Psychiatric disorders
Bipolar disorder
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Cranio-cerebral injury
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Immune system disorders
Allergy to arthropod sting
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
Other adverse events
| Measure |
Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel
n=329 participants at risk
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75)
n=328 participants at risk
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
Vehicle Gel
n=161 participants at risk
Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Cardiac disorders
Extrasystoles
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Cardiac disorders
Sinus tachycardia
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Endocrine disorders
Goitre
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Eye disorders
Eye irritation
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Eye disorders
Eye pain
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Eye disorders
Eye swelling
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Dry mouth
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Toothache
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site dryness
|
3.3%
11/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
2.7%
9/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site erosion
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site erythema
|
1.5%
5/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.8%
6/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site irritation
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.91%
3/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.9%
3/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site oedema
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site pain
|
1.2%
4/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
4/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Application site pruritus
|
1.2%
4/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.5%
5/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.9%
3/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Chest pain
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Cyst
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Face oedema
|
0.91%
3/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.5%
5/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Facial pain
|
4.9%
16/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
5.2%
17/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
3.1%
5/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Inflammation
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Local swelling
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Oedema
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Pain
|
2.4%
8/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.91%
3/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Pyrexia
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
General disorders
Secretion discharge
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Immune system disorders
Allergy to arthropod sting
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Body tinea
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Breast abscess
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Bronchitis
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Conjunctivitus
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Gastroenteritis viral
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Influenza
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Kidney infection
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Nasopharyngitis
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Oral herpes
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Otitis media
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Pneumonia
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Rash pustular
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Sinusitus
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Skin infection
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Infections and infestations
Upper respiratory tract infection
|
0.91%
3/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
4/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Investigations
Blood pressure increased
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Investigations
Heart rate increased
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Investigations
Heart rate irregular
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Investigations
Investigation
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Investigations
Investigation abnormal
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Investigations
Weight increased
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Nervous system disorders
Headache
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Nervous system disorders
Migraine
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Nervous system disorders
Paraesthesia
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Nervous system disorders
Presyncope
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Psychiatric disorders
Bipolar disorder
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Psychiatric disorders
Depression
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Renal and urinary disorders
Pollakiuria
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.7%
9/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
2.7%
9/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
6.2%
10/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
38.6%
127/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
42.1%
138/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
34.8%
56/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
55/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
17.7%
58/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
19.3%
31/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
59/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
21.3%
70/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
19.3%
31/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.61%
2/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.61%
2/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
10.3%
34/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
8.2%
27/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
6.8%
11/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
3.6%
12/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
6.7%
22/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
5.0%
8/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.2%
17/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
7.0%
23/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
6.2%
10/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.5%
5/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Surgical and medical procedures
Artificial crown procedure
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.30%
1/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Vascular disorders
Hot flush
|
0.00%
0/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.00%
0/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
0.62%
1/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
|
Vascular disorders
Hypotension
|
0.30%
1/329 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
4/328 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
1.2%
2/161 • Baseline to 12 Weeks
Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals USA, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER