Trial Outcomes & Findings for A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study (NCT NCT02413229)
NCT ID: NCT02413229
Last Updated: 2018-12-06
Results Overview
The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
28 Days
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
DSXS1411 5 Min
DSXS applied once a day for a total of 28 days for duration of 5 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 5 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 10 Min
DSXS applied once a day for a total of 28 days for duration of 10 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 10 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 15 Min
DSXS applied once a day for a total of 28 days for duration of 15 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 15 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 30 Min
DSXS applied once a day for a total of 28 days for duration of 30 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 30 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
12
|
26
|
12
|
24
|
12
|
25
|
15
|
|
Overall Study
COMPLETED
|
24
|
11
|
25
|
11
|
21
|
12
|
25
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
3
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
DSXS1411 5 Min
DSXS applied once a day for a total of 28 days for duration of 5 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 5 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 10 Min
DSXS applied once a day for a total of 28 days for duration of 10 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 10 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 15 Min
DSXS applied once a day for a total of 28 days for duration of 15 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 15 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 30 Min
DSXS applied once a day for a total of 28 days for duration of 30 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 30 Min
Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
Baseline characteristics by cohort
| Measure |
DSXS1411 5 Min
n=24 Participants
DSXS applied once a day for a total of 28 days for duration of 5 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 5 Min
n=12 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 10 Min
n=26 Participants
DSXS applied once a day for a total of 28 days for duration of 10 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 10 Min
n=12 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 15 Min
n=22 Participants
DSXS applied once a day for a total of 28 days for duration of 15 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 15 Min
n=12 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 30 Min
n=25 Participants
DSXS applied once a day for a total of 28 days for duration of 30 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 30 Min
n=15 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 18
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Age, Customized
18 - 40
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Age, Customized
41 - 64
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
76 Participants
n=42 Participants
|
|
Age, Customized
65 - 75
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Age, Customized
> 75
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
92 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
56 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
100 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
137 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Time Patient has Suffered from Symptoms
< 3 Months
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Time Patient has Suffered from Symptoms
3 to 6 Months
|
1 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=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Time Patient has Suffered from Symptoms
6 to 12 Months
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Time Patient has Suffered from Symptoms
> 1 Year And <= 3 Years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Time Patient has Suffered from Symptoms
> 3 Years And <= 5 Years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Time Patient has Suffered from Symptoms
> 5 Years
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
83 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 28 DaysThe proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.
Outcome measures
| Measure |
DSXS1411 5 Min
n=24 Participants
DSXS applied once a day for a total of 28 days for duration of 5 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 5 Min
n=12 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 10 Min
n=26 Participants
DSXS applied once a day for a total of 28 days for duration of 10 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 10 Min
n=12 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 15 Min
n=22 Participants
DSXS applied once a day for a total of 28 days for duration of 15 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 15 Min
n=12 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 30 Min
n=25 Participants
DSXS applied once a day for a total of 28 days for duration of 30 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 30 Min
n=15 Participants
Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
|---|---|---|---|---|---|---|---|---|
|
Clinical Response of Success
|
6 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
Adverse Events
DSXS1411 5 Min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo 5 Min
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DSXS1411 10 Min
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo 10 Min
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
DSXS1411 15 Min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo 15 Min
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DSXS1411 30 Min
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo 30 Min
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 |
DSXS1411 5 Min
n=24 participants at risk
DSXS applied once a day for a total of 28 days for duration of 5 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 5 Min
n=12 participants at risk
Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 10 Min
n=26 participants at risk
DSXS applied once a day for a total of 28 days for duration of 10 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 10 Min
n=12 participants at risk
Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 15 Min
n=22 participants at risk
DSXS applied once a day for a total of 28 days for duration of 15 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 15 Min
n=12 participants at risk
Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
DSXS1411 30 Min
n=25 participants at risk
DSXS applied once a day for a total of 28 days for duration of 30 minutes.
DSXS1411: DSXS (Taro Pharmaceuticals Inc.)
|
Placebo 30 Min
n=15 participants at risk
Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes.
Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.)
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
6.7%
1/15 • Number of events 1 • 5 months
|
|
General disorders
Application site pain
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
3.8%
1/26 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/25 • 5 months
|
6.7%
1/15 • Number of events 1 • 5 months
|
|
General disorders
Application site pruritis
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
13.3%
2/15 • Number of events 2 • 5 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
3.8%
1/26 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Blood and lymphatic system disorders
Blood alkaline phosphatase increased
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
6.7%
1/15 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
Blood glucose increased
|
4.2%
1/24 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Eye disorders
Dry eye
|
4.2%
1/24 • Number of events 1 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Eye disorders
Eye pain
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
4.5%
1/22 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
16.7%
2/12 • Number of events 2 • 5 months
|
4.5%
1/22 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
12.0%
3/25 • Number of events 3 • 5 months
|
0.00%
0/15 • 5 months
|
|
Hepatobiliary disorders
Hepatic enzyme increased
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Cardiac disorders
Hypertension
|
0.00%
0/24 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
4.5%
1/22 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Infections and infestations
Influenza
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
3.8%
1/26 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
6.7%
1/15 • Number of events 1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.2%
1/24 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
4.5%
1/22 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
6.7%
1/15 • Number of events 1 • 5 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
6.7%
1/15 • Number of events 1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.2%
1/24 • Number of events 1 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
0.00%
0/12 • 5 months
|
4.0%
1/25 • Number of events 1 • 5 months
|
0.00%
0/15 • 5 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/24 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/26 • 5 months
|
0.00%
0/12 • 5 months
|
0.00%
0/22 • 5 months
|
8.3%
1/12 • Number of events 1 • 5 months
|
0.00%
0/25 • 5 months
|
0.00%
0/15 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place