Trial Outcomes & Findings for A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea (NCT NCT02120924)
NCT ID: NCT02120924
Last Updated: 2020-06-02
Results Overview
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1009 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
Azelaic Acid, 15% Topical Gel
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15% (Intendis)
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
|---|---|---|---|
|
Overall Study
STARTED
|
404
|
403
|
202
|
|
Overall Study
COMPLETED
|
362
|
357
|
173
|
|
Overall Study
NOT COMPLETED
|
42
|
46
|
29
|
Reasons for withdrawal
| Measure |
Azelaic Acid, 15% Topical Gel
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15% (Intendis)
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
16
|
20
|
8
|
|
Overall Study
Lost to Follow-up
|
14
|
14
|
11
|
|
Overall Study
Pregnancy
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
7
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Compliance with IP
|
5
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea
Baseline characteristics by cohort
| Measure |
Azelaic Acid, 15% Topical Gel
n=293 Participants
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15%
n=274 Participants
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
n=127 Participants
Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Total
n=694 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.71 • n=99 Participants
|
50.0 years
STANDARD_DEVIATION 12.42 • n=107 Participants
|
51.4 years
STANDARD_DEVIATION 11.73 • n=206 Participants
|
50.8 years
STANDARD_DEVIATION 12.42 • n=7 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
479 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
215 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
118 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
303 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
175 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
391 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
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
280 Participants
n=99 Participants
|
263 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
667 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
20 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
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Per protocol population
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.
Outcome measures
| Measure |
Azelaic Acid, 15% Topical Gel
n=293 Participants
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15%
n=274 Participants
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
n=127 Participants
Placebo product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
|---|---|---|---|
|
Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts.
|
-66.96 Percent change in lesion counts
Standard Deviation 29.394
|
-68.62 Percent change in lesion counts
Standard Deviation 27.415
|
-38.64 Percent change in lesion counts
Standard Deviation 46.845
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Analysis of Treatment Success Based on IGE Score at Week 12 in PP Population.
The secondary endpoint is the clinical response of "success" or "failure" at Week 12 on the IGE. Success is defined as an IGE score of 0 (clear) or 1 (almost clear). Any subject who is not considered to be a success will be considered to be a failure. Score-Grade-Definition 0 - Clear - No inflammatory lesions present; at most, mild erythema. 1. \- Almost Clear - Very mild erythema present. Very few small papules/pustules. 2. \- Mild - Mild erythema. Several small papules/pustules. 3. \- Moderate - Moderate erythema. Several small or large papules/pustules, and up to two nodules. 4. \- Severe - Severe erythema. Numerous small and/or large papules/pustules, up to several nodules.
Outcome measures
| Measure |
Azelaic Acid, 15% Topical Gel
n=293 Participants
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15%
n=274 Participants
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
n=127 Participants
Placebo product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
|---|---|---|---|
|
The Percentage of Subjects With a Clinical Response of "Success" at Week 12 Using Investigator Global Evaluation (IGE)
Success
|
138 Participants
|
117 Participants
|
40 Participants
|
|
The Percentage of Subjects With a Clinical Response of "Success" at Week 12 Using Investigator Global Evaluation (IGE)
Failure
|
155 Participants
|
157 Participants
|
87 Participants
|
Adverse Events
Azelaic Acid, 15% Topical Gel
Serious events: 1 serious events
Other events: 109 other events
Deaths: 1 deaths
Finacea® (Azelaic Acid) Gel, 15%
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Gel Vehicle
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azelaic Acid, 15% Topical Gel
n=390 participants at risk
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15%
n=386 participants at risk
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
n=190 participants at risk
Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
Other adverse events
| Measure |
Azelaic Acid, 15% Topical Gel
n=390 participants at risk
Test product: Azelaic Acid, 15% topical gel (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Finacea® (Azelaic Acid) Gel, 15%
n=386 participants at risk
Reference product: Finacea® (azelaic acid) Gel, 15% (Intendis)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
Gel Vehicle
n=190 participants at risk
Placebo product: Gel Vehicle of the test product (Watson Laboratories, Inc.)
Azelaic acid: Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Ear and labyrinth disorders
Ear pain
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Blepharospasm
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Eye irritation
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Eye pain
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Foreign body sensation in eye
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Lacrimation increased
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Eye disorders
Vision blurred
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.77%
3/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.78%
3/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.3%
5/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.3%
5/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
5/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Tooth crowding
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.0%
4/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Application site pain
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Application site pruritus
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Chills
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Fatigue
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Feeling hot
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Influenza like illness
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.78%
3/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Local swelling
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Malaise
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Pain
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.78%
3/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
General disorders
Pyrexia
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Hepatobiliary disorders
Biliary colic
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Immune system disorders
Hypersensitivity
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Acute sinusitis
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Atypical pnuemonia
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.78%
3/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Ear infection
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Eye infection
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.78%
3/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Influenza
|
1.5%
6/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.0%
4/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
27/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
4.9%
19/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
4.7%
9/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Pertussis
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Sinusitis
|
1.5%
6/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.8%
7/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Skin infection
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Subcutaneous abscess
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Tonsillitus
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.77%
3/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.3%
5/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.6%
3/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Investigations
Heart rate increased
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
4/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.3%
5/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Invertebral disc protrusion
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal pain
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Burning sensation
|
1.0%
4/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.3%
5/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Dizziness
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Headache
|
5.9%
23/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
6.0%
23/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
5.8%
11/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Migraine
|
0.77%
3/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.6%
3/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.5%
6/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Reproductive system and breast disorders
Premenstrual headache
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.77%
3/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.3%
5/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.77%
3/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.6%
3/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
5/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
5/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.0%
4/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
2.1%
4/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
6/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.78%
3/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.1%
2/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
1.0%
4/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
2.1%
4/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.52%
2/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.51%
2/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.00%
0/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.26%
1/390 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.26%
1/386 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
0.53%
1/190 • Adverse events were monitored and collected over a period of at least 12 weeks, through to study completion.
|
Additional Information
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