Trial Outcomes & Findings for An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis (NCT NCT03200912)
NCT ID: NCT03200912
Last Updated: 2020-01-14
Results Overview
Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
57 days
Results posted on
2020-01-14
Participant Flow
The populations for this study included the Safety Population, the Per-Protocol Population, and the modified Intent-to-Treat (mITT) population.
Participant milestones
| Measure |
Generic Ingenol Mebutate
Generic ingenol mebutate gel, 0.015% \[Test\]
Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand
|
Picato (Ingenol Mebutate)
Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]
Ingenol Mebutate (Picato®): Brand product
|
Vehicle Gel
Vehicle gel of the test product
Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
|
|---|---|---|---|
|
Overall Study
STARTED
|
170
|
169
|
168
|
|
Overall Study
COMPLETED
|
166
|
166
|
164
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Generic Ingenol Mebutate
Generic ingenol mebutate gel, 0.015% \[Test\]
Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand
|
Picato (Ingenol Mebutate)
Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]
Ingenol Mebutate (Picato®): Brand product
|
Vehicle Gel
Vehicle gel of the test product
Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
4
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
0
|
Baseline Characteristics
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Generic Ingenol Mebutate
n=170 Participants
Generic ingenol mebutate gel, 0.015% \[Test\]
Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand
|
Picato (Ingenol Mebutate)
n=169 Participants
Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]
Ingenol Mebutate (Picato®): Brand product
|
Vehicle Gel
n=168 Participants
Vehicle gel of the test product
Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
409 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
464 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
170 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
505 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: AK Complete Clearance Rate at Day 57 (PP population)
Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area
Outcome measures
| Measure |
Generic Ingenol Mebutate
n=137 Participants
Generic ingenol mebutate gel, 0.015% \[Test\]
Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand
|
Picato (Ingenol Mebutate)
n=144 Participants
Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]
Ingenol Mebutate (Picato®): Brand product
|
Vehicle Gel
n=139 Participants
Vehicle gel of the test product
Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
|
|---|---|---|---|
|
Complete Clearance of AK Lesions
|
45 Participants
|
44 Participants
|
7 Participants
|
Adverse Events
Generic Ingenol Mebutate
Serious events: 2 serious events
Other events: 29 other events
Deaths: 29 deaths
Picato (Ingenol Mebutate)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 29 deaths
Vehicle Gel
Serious events: 2 serious events
Other events: 24 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Generic Ingenol Mebutate
n=170 participants at risk
Generic ingenol mebutate gel, 0.015% \[Test\]
Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand
|
Picato (Ingenol Mebutate)
n=169 participants at risk
Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]
Ingenol Mebutate (Picato®): Brand product
|
Vehicle Gel
n=168 participants at risk
Vehicle gel of the test product
Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
|
|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.59%
1/170 • Number of events 1 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Cardiac disorders
Atrial fibrillation with hospitalization
|
0.59%
1/170 • Number of events 1 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Number of events 1 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Number of events 1 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
Other adverse events
| Measure |
Generic Ingenol Mebutate
n=170 participants at risk
Generic ingenol mebutate gel, 0.015% \[Test\]
Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand
|
Picato (Ingenol Mebutate)
n=169 participants at risk
Picato® (ingenol mebutate) gel, 0.015% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\]
Ingenol Mebutate (Picato®): Brand product
|
Vehicle Gel
n=168 participants at risk
Vehicle gel of the test product
Vehicle Gel: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Eye disorders
Eye swelling
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Eye disorders
Abdominal pain upper
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Eye disorders
Dental caries
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
General disorders
Application site erythema
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
General disorders
Application site inflammation
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
General disorders
Application site pain
|
3.5%
6/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
3.6%
6/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
General disorders
Application site pruritus
|
1.8%
3/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
1.2%
2/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
General disorders
Application site swelling
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Diverticulitis
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Herpes zoster
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Influenza
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
3/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
1.8%
3/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
4.2%
7/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Pneumonia
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Sinusitus
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
1.8%
3/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Tooth abscess
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Tooth infection
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
3.6%
6/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Nervous system disorders
Headache
|
1.2%
2/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
1.2%
2/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.59%
1/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.60%
1/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.59%
1/170 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/169 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
0.00%
0/168 • Adverse event data was collected from the time of the study start until end of study on Day 57 of the study.
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals Inc. USA
Phone: 1-888-483-8259
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place