Trial Outcomes & Findings for A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea (NCT NCT03287791)
NCT ID: NCT03287791
Last Updated: 2019-07-31
Results Overview
All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion \>5 mm in diameter.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
924 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2019-07-31
Participant Flow
The populations for this study included the Safety Population, the modified Intent-to-Treat (mITT) population, and the Per-Protocol (PP) Population.
If participant failed to return diary card and had no evidence of study drug use, then •participant was included in Safety population if there was some participant safety or efficacy data after Baseline •participant considered lost to follow up and excluded from Safety Population if there was no participant safety or efficacy data after Baseline
Participant milestones
| Measure |
Generic Azelaic Acid Foam
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks (wks). Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
312
|
312
|
300
|
|
Overall Study
Safety Population
|
306
|
297
|
291
|
|
Overall Study
mITT Population
|
291
|
291
|
283
|
|
Overall Study
PP Population
|
262
|
259
|
245
|
|
Overall Study
COMPLETED
|
280
|
276
|
264
|
|
Overall Study
NOT COMPLETED
|
32
|
36
|
36
|
Reasons for withdrawal
| Measure |
Generic Azelaic Acid Foam
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks (wks). Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
|---|---|---|---|
|
Overall Study
Insufficient Therapeutic Response
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
17
|
|
Overall Study
Missed more than 6 consecutive doses
|
3
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
11
|
|
Overall Study
Protocol Violation
|
7
|
2
|
1
|
|
Overall Study
Participant was enrolled at 2 sites
|
1
|
0
|
1
|
|
Overall Study
Too much time between 2 visits
|
0
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
|
Overall Study
Did not meet inclusion criteria
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea
Baseline characteristics by cohort
| Measure |
Generic Azelaic Acid Foam
n=306 Participants
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
n=297 Participants
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
n=291 Participants
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Total
n=894 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 14.20 • n=99 Participants
|
52.3 years
STANDARD_DEVIATION 15.14 • n=107 Participants
|
51.0 years
STANDARD_DEVIATION 15.09 • n=206 Participants
|
51.6 years
STANDARD_DEVIATION 14.80 • n=7 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=99 Participants
|
220 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
636 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
258 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
185 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
542 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
352 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
302 Participants
n=99 Participants
|
292 Participants
n=107 Participants
|
288 Participants
n=206 Participants
|
882 Participants
n=7 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Inflammatory Lesion Count
|
17.1 inflammatory lesions
STANDARD_DEVIATION 8.85 • n=99 Participants
|
16.7 inflammatory lesions
STANDARD_DEVIATION 7.88 • n=107 Participants
|
17.7 inflammatory lesions
STANDARD_DEVIATION 8.88 • n=206 Participants
|
17.1 inflammatory lesions
STANDARD_DEVIATION 8.55 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: Participants in the PP Population. If participant discontinued between 8 and 12 weeks of treatment due to lack of treatment, last observation carried forward (LOCF) was used to impute the number of lesions. If participant was missing Week 12 assessment for any other reason, participant was excluded.
All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion \>5 mm in diameter.
Outcome measures
| Measure |
Generic Azelaic Acid Foam
n=262 Participants
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
n=259 Participants
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
n=245 Participants
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
|---|---|---|---|
|
Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12
|
-64.28 percent change
Standard Deviation 25.050
|
-65.15 percent change
Standard Deviation 26.419
|
-57.84 percent change
Standard Deviation 30.626
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Participants in the PP Population. Participants who did not have a valid Week 12 assessment for any other reason were excluded from the PP analysis.
Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Outcome measures
| Measure |
Generic Azelaic Acid Foam
n=262 Participants
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
n=259 Participants
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
n=245 Participants
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
|---|---|---|---|
|
Percentage of Participants With Treatment Success Based on IGE Score
|
39.7 percentage of participants
|
48.3 percentage of participants
|
33.5 percentage of participants
|
Adverse Events
Generic Azelaic Acid Foam
Serious events: 0 serious events
Other events: 129 other events
Deaths: 0 deaths
Finacea (Azelaic Acid) Foam
Serious events: 2 serious events
Other events: 128 other events
Deaths: 0 deaths
Vehicle Foam
Serious events: 1 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Generic Azelaic Acid Foam
n=306 participants at risk
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
n=297 participants at risk
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
n=291 participants at risk
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
|---|---|---|---|
|
Renal and urinary disorders
Prostate cancer
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Number of events 1 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Immune system disorders
Cellulitis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Number of events 1 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Endocrine disorders
Hypocalcaemia
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Number of events 1 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
Other adverse events
| Measure |
Generic Azelaic Acid Foam
n=306 participants at risk
A thin layer of generic azelaic acid, 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Finacea (Azelaic Acid) Foam
n=297 participants at risk
A thin layer of Finacea (azelaic acid), 15% topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
Vehicle Foam
n=291 participants at risk
A thin layer of the vehicle topical foam was to be gently massaged into the entire facial area twice daily, once in the morning and once in the evening, for 12 weeks. Contact with the mouth, eyes, and other mucous membranes was to be avoided. Hands were to be washed following application of study drug. Participants were instructed not to bathe, shower, wash, or swim for at least 4 hours after application of study drug. Participants were provided with mild cleanser, a towel, sunscreen, and moisturizing lotion to be used on treated areas while participating in the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.98%
3/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.0%
3/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.0%
3/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.69%
2/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Eye disorders
Dacryostenosis acquired
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Eye disorders
Eye swelling
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Eye disorders
Ocular hyperaemia
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site acne
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site dryness
|
14.7%
45/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
9.8%
29/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
17.9%
52/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site erythema
|
9.8%
30/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
9.4%
28/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
11.7%
34/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site exfoliation
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site inflammation
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site irritation
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site oedema
|
0.98%
3/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.3%
4/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.7%
5/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site pain
|
15.4%
47/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
13.8%
41/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
9.6%
28/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site pruritus
|
16.7%
51/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
14.5%
43/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
9.6%
28/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site reaction
|
7.2%
22/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
6.4%
19/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
6.9%
20/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site swelling
|
0.65%
2/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
2.0%
6/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
2.7%
8/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Application site vesicles
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Fatigue
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Oedema peripheral
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
General disorders
Pyrexia
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Application site folliculitis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Application site pustules
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Influenza
|
2.0%
6/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.69%
2/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Nasopharyngitis
|
0.65%
2/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.3%
4/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.0%
3/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Oral herpes
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Pertussis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Pneumonia
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Sinusitis
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.7%
5/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.0%
3/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Investigations
Biopsy skin
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.69%
2/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.7%
5/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.4%
4/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
2/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
1.3%
4/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.69%
2/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Nervous system disorders
Headache
|
4.9%
15/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
3.0%
9/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
4.1%
12/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Nervous system disorders
Migraine
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Nervous system disorders
Sinus headache
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.98%
3/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.67%
2/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.69%
2/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Surgical and medical procedures
Cataract operation
|
0.33%
1/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Vascular disorders
Hypertension
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
|
Vascular disorders
Hypotension
|
0.00%
0/306 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.00%
0/297 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
0.34%
1/291 • Baseline up to Day 84
Adverse events were collected from participants who were randomized and had evidence in diary card of using ≥1 dose of study drug (Safety Population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of Multicenter data.
- Publication restrictions are in place
Restriction type: OTHER