Trial Outcomes & Findings for A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream" (NCT NCT03954444)
NCT ID: NCT03954444
Last Updated: 2021-06-23
Results Overview
The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1105 participants
Primary outcome timeframe
29 days
Results posted on
2021-06-23
Participant Flow
Participant milestones
| Measure |
Oxymetazoline Hydrochloride Cream, 1%
Oxymetazoline hydrochloride cream, 1%
Oxymetazoline Hydrochloride: Test Comparator
Subjects applied once daily to face for 29 days
|
RHOFADE Cream, 1%
RHOFADE Cream, 1%
Rhofade Cream, 1%: Reference Comparator
Subjects applied once daily to face for 29 days
|
Vehicle Cream
Vehicle cream
Placebo: Placebo Comparator
Subjects applied once daily to face for 29 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
379
|
382
|
344
|
|
Overall Study
COMPLETED
|
366
|
366
|
327
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
17
|
Reasons for withdrawal
| Measure |
Oxymetazoline Hydrochloride Cream, 1%
Oxymetazoline hydrochloride cream, 1%
Oxymetazoline Hydrochloride: Test Comparator
Subjects applied once daily to face for 29 days
|
RHOFADE Cream, 1%
RHOFADE Cream, 1%
Rhofade Cream, 1%: Reference Comparator
Subjects applied once daily to face for 29 days
|
Vehicle Cream
Vehicle cream
Placebo: Placebo Comparator
Subjects applied once daily to face for 29 days
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
5
|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
3
|
5
|
|
Overall Study
Use of prohibited therapy
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Non-compliant with study drug application
|
2
|
2
|
0
|
|
Overall Study
Administrative reasons
|
0
|
0
|
1
|
|
Overall Study
Miscellaneous
|
3
|
2
|
1
|
Baseline Characteristics
A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"
Baseline characteristics by cohort
| Measure |
Oxymetazoline Hydrochloride Cream, 1%
n=379 Participants
Oxymetazoline hydrochloride cream, 1%
Oxymetazoline Hydrochloride: Test Comparator
|
RHOFADE Cream, 1%
n=382 Participants
RHOFADE Cream, 1%
Rhofade Cream, 1%: Reference Comparator
|
Vehicle Cream
n=344 Participants
Vehicle cream
Placebo: Placebo Comparator
|
Total
n=1105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 14.01 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 14.11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
282 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
824 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
281 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
202 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
589 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
177 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
516 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
369 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
1083 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Clinical Erythema Assessment Score
0-Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Clinical Erythema Assessment Score
1-Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Clinical Erythema Assessment Score
2-Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Clinical Erythema Assessment Score
3-Moderate
|
287 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
852 Participants
n=4 Participants
|
|
Baseline Clinical Erythema Assessment Score
4-Severe
|
92 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Baseline Subject Self-Assessment
0-No Sign
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Subject Self-Assessment
1-Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Subject Self-Assessment
2-Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Subject Self-Assessment
3-Moderate
|
282 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
830 Participants
n=4 Participants
|
|
Baseline Subject Self-Assessment
4-Severe
|
97 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
275 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 29 daysPopulation: Equivalence Analysis of the Primary Endpoint (Per Protocol Population)
The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).
Outcome measures
| Measure |
Oxymetazoline Hydrochloride Cream, 1%
n=349 Participants
Oxymetazoline hydrochloride cream, 1%
Oxymetazoline Hydrochloride: Test Comparator
|
RHOFADE Cream, 1%
n=356 Participants
RHOFADE Cream, 1%
Rhofade Cream, 1%: Reference Comparator
|
Vehicle Cream
n=316 Participants
Vehicle cream
Placebo: Placebo Comparator
|
|---|---|---|---|
|
Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value
Success
|
78 Participants
|
70 Participants
|
51 Participants
|
|
Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value
Failure
|
271 Participants
|
286 Participants
|
265 Participants
|
Adverse Events
Oxymetazoline Hydrochloride Cream, 1%
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
RHOFADE Cream, 1%
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxymetazoline Hydrochloride Cream, 1%
n=379 participants at risk
Oxymetazoline hydrochloride cream, 1%
Oxymetazoline Hydrochloride: Test Comparator
|
RHOFADE Cream, 1%
n=382 participants at risk
RHOFADE Cream, 1%
Rhofade Cream, 1%: Reference Comparator
|
Vehicle Cream
n=344 participants at risk
Vehicle cream
Placebo: Placebo Comparator
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • Number of events 1 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • Number of events 1 • 2 month adverse event data collection
|
Other adverse events
| Measure |
Oxymetazoline Hydrochloride Cream, 1%
n=379 participants at risk
Oxymetazoline hydrochloride cream, 1%
Oxymetazoline Hydrochloride: Test Comparator
|
RHOFADE Cream, 1%
n=382 participants at risk
RHOFADE Cream, 1%
Rhofade Cream, 1%: Reference Comparator
|
Vehicle Cream
n=344 participants at risk
Vehicle cream
Placebo: Placebo Comparator
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Eye disorders
Eye irritation
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
General disorders
Application site acne
|
1.1%
4/379 • 2 month adverse event data collection
|
1.6%
6/382 • 2 month adverse event data collection
|
0.58%
2/344 • 2 month adverse event data collection
|
|
General disorders
Application site dermatitis
|
0.79%
3/379 • 2 month adverse event data collection
|
0.52%
2/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
General disorders
Application site dryness
|
1.3%
5/379 • 2 month adverse event data collection
|
0.52%
2/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
General disorders
Application site erythema
|
1.8%
7/379 • 2 month adverse event data collection
|
2.6%
10/382 • 2 month adverse event data collection
|
2.0%
7/344 • 2 month adverse event data collection
|
|
General disorders
Application site exfoliation
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
General disorders
Application site hypoaesthesia
|
0.26%
1/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Application site irritation
|
0.53%
2/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Application site pain
|
2.4%
9/379 • 2 month adverse event data collection
|
4.2%
16/382 • 2 month adverse event data collection
|
2.9%
10/344 • 2 month adverse event data collection
|
|
General disorders
Application site papules
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Application site paraesthesis
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Application site pruritus
|
3.7%
14/379 • 2 month adverse event data collection
|
4.2%
16/382 • 2 month adverse event data collection
|
2.0%
7/344 • 2 month adverse event data collection
|
|
General disorders
Application site rash
|
0.53%
2/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Application site reaction
|
2.1%
8/379 • 2 month adverse event data collection
|
0.52%
2/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
General disorders
Application site swelling
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
General disorders
Oedema peripheral
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Pain
|
0.26%
1/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
General disorders
Pyrexia
|
0.26%
1/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Infections and infestations
Application site pustules
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Infections and infestations
Bronchitis
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Infections and infestations
Influenza
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.58%
2/344 • 2 month adverse event data collection
|
|
Infections and infestations
Nasopharyngitis
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Infections and infestations
Postoperative wound infection
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Infections and infestations
Tooth infection
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.87%
3/344 • 2 month adverse event data collection
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.58%
2/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.58%
2/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
1/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.53%
2/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Nervous system disorders
Burning sensation
|
0.26%
1/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Nervous system disorders
Headache
|
2.4%
9/379 • 2 month adverse event data collection
|
2.9%
11/382 • 2 month adverse event data collection
|
3.5%
12/344 • 2 month adverse event data collection
|
|
Nervous system disorders
Migraine
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Nervous system disorders
Sinus headache
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
1/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.79%
3/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.53%
2/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/379 • 2 month adverse event data collection
|
0.26%
1/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.26%
1/379 • 2 month adverse event data collection
|
0.79%
3/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.29%
1/344 • 2 month adverse event data collection
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.26%
1/379 • 2 month adverse event data collection
|
0.00%
0/382 • 2 month adverse event data collection
|
0.00%
0/344 • 2 month adverse event data collection
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals Development Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER