Trial Outcomes & Findings for A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris (NCT NCT01631474)
NCT ID: NCT01631474
Last Updated: 2020-11-16
Results Overview
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
363 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2020-11-16
Participant Flow
Participant milestones
| Measure |
Low-dose Active, BID
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
72
|
76
|
70
|
70
|
75
|
|
Overall Study
COMPLETED
|
58
|
64
|
61
|
59
|
62
|
|
Overall Study
NOT COMPLETED
|
14
|
12
|
9
|
11
|
13
|
Reasons for withdrawal
| Measure |
Low-dose Active, BID
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
7
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
2
|
6
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
0
|
0
|
2
|
|
Overall Study
Noncompliance with Study Drug
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Low-dose Active, BID
n=72 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=76 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=70 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=70 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=75 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
19.8 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
20.4 years
STANDARD_DEVIATION 6.31 • n=7 Participants
|
18.3 years
STANDARD_DEVIATION 6.14 • n=5 Participants
|
21.0 years
STANDARD_DEVIATION 6.22 • n=4 Participants
|
19.2 years
STANDARD_DEVIATION 5.25 • n=21 Participants
|
19.7 years
STANDARD_DEVIATION 5.99 • n=8 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
196 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
167 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
76 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
287 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=8 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
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
74 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
257 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Baseline IGA
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Baseline IGA
1 - Almost clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Baseline IGA
2 - Mild
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Baseline IGA
3 - Moderate
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
247 Participants
n=8 Participants
|
|
Baseline IGA
4 - Severe
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
|
Baseline lesions counts
Inflammatory lesions
|
29.9 lesions
n=5 Participants
|
29.0 lesions
n=7 Participants
|
31.9 lesions
n=5 Participants
|
28.6 lesions
n=4 Participants
|
30.5 lesions
n=21 Participants
|
30.0 lesions
n=8 Participants
|
|
Baseline lesions counts
Non-inflammatory lesions
|
43.5 lesions
n=5 Participants
|
44.5 lesions
n=7 Participants
|
46.7 lesions
n=5 Participants
|
47.2 lesions
n=4 Participants
|
43.9 lesions
n=21 Participants
|
45.2 lesions
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Per-Protocol Population, defined as a subset of the ITT population and included those subjects that met eligibility criteria, completed the end-of-study visit, and applied at least 80% of the expected treatment applications.
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Outcome measures
| Measure |
Low-dose Active, BID
n=57 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=64 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=52 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=55 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=59 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) "Success" - Week 12
|
5 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Per protocol population.
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
Outcome measures
| Measure |
Low-dose Active, BID
n=55 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=62 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=52 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=55 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=57 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Inflammatory and Non-Inflammatory Lesion Counts - Week 12
Inflammatory lesions
|
-8.3 lesions
Standard Deviation 14.63
|
-5.8 lesions
Standard Deviation 11.99
|
-10.1 lesions
Standard Deviation 12.53
|
-12.3 lesions
Standard Deviation 14.43
|
-9.1 lesions
Standard Deviation 13.67
|
|
Inflammatory and Non-Inflammatory Lesion Counts - Week 12
Non-inflammatory lesions
|
-8.7 lesions
Standard Deviation 18.16
|
-6.1 lesions
Standard Deviation 29.22
|
-8.4 lesions
Standard Deviation 21.55
|
-15.5 lesions
Standard Deviation 20.48
|
-6.7 lesions
Standard Deviation 19.65
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per protocol population
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
Outcome measures
| Measure |
Low-dose Active, BID
n=54 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=62 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=52 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=53 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=56 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Inflammatory and Non-Inflammatory Lesion Counts - Week 8
Inflammatory lesions
|
-11.9 lesions
Standard Deviation 8.84
|
-7.2 lesions
Standard Deviation 12.03
|
-7.2 lesions
Standard Deviation 17.21
|
-11.5 lesions
Standard Deviation 11.19
|
-11.3 lesions
Standard Deviation 12.71
|
|
Inflammatory and Non-Inflammatory Lesion Counts - Week 8
Non-inflammatory lesions
|
-7.0 lesions
Standard Deviation 13.76
|
-6.7 lesions
Standard Deviation 16.33
|
-3.2 lesions
Standard Deviation 37.01
|
-13.6 lesions
Standard Deviation 17.99
|
-8.3 lesions
Standard Deviation 17.12
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: Per protocol population
Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.
Outcome measures
| Measure |
Low-dose Active, BID
n=54 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=62 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=52 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=53 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=56 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Percent Change in Lesion Counts - Weeks 8 and 12
Inflammatory lesions (Week 8)
|
-40.6 percentage of change
Standard Deviation 28.20
|
-26.6 percentage of change
Standard Deviation 37.35
|
-27.5 percentage of change
Standard Deviation 41.44
|
-41.1 percentage of change
Standard Deviation 36.54
|
-36.0 percentage of change
Standard Deviation 35.01
|
|
Percent Change in Lesion Counts - Weeks 8 and 12
Inflammatory lesions (Week 12)
|
-26.8 percentage of change
Standard Deviation 50.78
|
-21.3 percentage of change
Standard Deviation 45.33
|
-32.5 percentage of change
Standard Deviation 35.51
|
-41.8 percentage of change
Standard Deviation 52.25
|
-28.4 percentage of change
Standard Deviation 41.88
|
|
Percent Change in Lesion Counts - Weeks 8 and 12
Non-inflammatory lesions (Week 8)
|
-18.3 percentage of change
Standard Deviation 34.50
|
-19.5 percentage of change
Standard Deviation 36.49
|
-10.5 percentage of change
Standard Deviation 57.13
|
-33.5 percentage of change
Standard Deviation 39.26
|
-24.3 percentage of change
Standard Deviation 43.23
|
|
Percent Change in Lesion Counts - Weeks 8 and 12
Non-inflammatory lesions (Week 12)
|
-24.3 percentage of change
Standard Deviation 38.69
|
-16.9 percentage of change
Standard Deviation 55.66
|
-19.5 percentage of change
Standard Deviation 40.75
|
-34.1 percentage of change
Standard Deviation 46.95
|
-19.5 percentage of change
Standard Deviation 47.43
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per protocol population.
Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
Outcome measures
| Measure |
Low-dose Active, BID
n=54 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=62 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=52 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=53 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=56 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
IGA "Success" - Week 8
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 12Population: Per protocol population.
Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.
Outcome measures
| Measure |
Low-dose Active, BID
n=57 Participants
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=64 Participants
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=52 Participants
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=55 Participants
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=59 Participants
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Week 4
|
3 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
|
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Week 8
|
3 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
|
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Week 12
|
6 Participants
|
4 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
Adverse Events
Low-dose Active, BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Medium-dose Active, BID
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
High-dose Active, QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
High-dose Active, BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle, QD or BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low-dose Active, BID
n=72 participants at risk
low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Medium-dose Active, BID
n=76 participants at risk
medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
High-dose Active, QD
n=70 participants at risk
high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day
|
High-dose Active, BID
n=70 participants at risk
high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day
|
Vehicle, QD or BID
n=75 participants at risk
vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
6/72 • Number of events 6 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
10.5%
8/76 • Number of events 8 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
2.9%
2/70 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
4.3%
3/70 • Number of events 3 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
2.7%
2/75 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/72 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/76 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
5.7%
4/70 • Number of events 4 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
1.4%
1/70 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/75 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
1/72 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
5.3%
4/76 • Number of events 4 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
1.4%
1/70 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/75 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
|
Nervous system disorders
Headache
|
2.8%
2/72 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
1.3%
1/76 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
2.7%
2/75 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
|
General disorders
Pyrexia
|
0.00%
0/72 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
2.6%
2/76 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
2.9%
2/70 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/75 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/72 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
2.6%
2/76 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
1.4%
1/70 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
1.3%
1/75 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.8%
2/72 • Number of events 2 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
1.3%
1/76 • Number of events 1 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/70 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
0.00%
0/75 • Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER