Trial Outcomes & Findings for A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (NCT NCT02267382)
NCT ID: NCT02267382
Last Updated: 2019-10-15
Results Overview
A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
254 participants
Primary outcome timeframe
48 Weeks
Results posted on
2019-10-15
Participant Flow
A total of 254 subjects were enrolled in the 14-day open-label Induction Phase of the study after providing consent. Those subjects whose acute VVC infections resolved during the Induction Phase (a total of 215) entered the Maintenance Phase of the study.
Participant milestones
| Measure |
VT-1161 Low-dose 3-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 Low-dose 6-month
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
|
VT-1161 High-dose 3-month
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 High-dose 24-week
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
|
Placebo
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
43
|
41
|
46
|
|
Overall Study
COMPLETED
|
35
|
33
|
34
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
9
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Baseline characteristics by cohort
| Measure |
VT-1161 Low-dose 3-month
n=42 Participants
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 Low-dose 6-month
n=43 Participants
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
|
VT-1161 High-dose 3-month
n=43 Participants
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 High-dose 24-week
n=41 Participants
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
|
Placebo
n=46 Participants
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 10.13 • n=4 Participants
|
35.4 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
34.6 years
STANDARD_DEVIATION 9.95 • n=8 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
215 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
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
|
PRIMARY outcome
Timeframe: 48 WeeksA culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome. 0 = none (complete absence of any sign or symptom) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
Outcome measures
| Measure |
VT-1161 Low-dose 3-month
n=42 Participants
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 Low-dose 6-month
n=43 Participants
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
|
VT-1161 High-dose 3-month
n=43 Participants
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 High-dose 24-week
n=41 Participants
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
|
Placebo
n=46 Participants
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
|
|---|---|---|---|---|---|
|
The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
24 Participants
|
Adverse Events
VT-1161 Low-dose 3-month
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
VT-1161 Low-dose 6-month
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
VT-1161 High-dose 3-month
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
VT-1161 High-dose 24-week
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VT-1161 Low-dose 3-month
n=41 participants at risk
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 Low-dose 6-month
n=42 participants at risk
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
|
VT-1161 High-dose 3-month
n=42 participants at risk
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 High-dose 24-week
n=41 participants at risk
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
|
Placebo
n=45 participants at risk
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
Other adverse events
| Measure |
VT-1161 Low-dose 3-month
n=41 participants at risk
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 Low-dose 6-month
n=42 participants at risk
1 VT-1161 150mg tablet and 1 placebo tablet once daily for 7 days, then once weekly for 23 weeks
|
VT-1161 High-dose 3-month
n=42 participants at risk
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 11 weeks, followed by 2 placebo tablet once weekly for 12 weeks
|
VT-1161 High-dose 24-week
n=41 participants at risk
2 VT-1161 150mg tablets once daily for 7 days, then once weekly for 23 weeks
|
Placebo
n=45 participants at risk
2 placebo tablets once daily for 7 days, then once weekly for 23 weeks
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Dental carries
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Chest pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Device breakage
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Fatigue
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Influenza-like illness
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Mass
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Pain
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Pyrexia
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
General disorders
Ulcer
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Immune system disorders
Food allergy
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Immune system disorders
Rubber sensitivity
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Bacterial vaginosis
|
17.1%
7/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
14.3%
6/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
16.7%
7/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
20.0%
9/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Cystitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Ear infection
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Escherichia vaginitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Eye infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Helicobacter infection
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Influenza
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Laryngitis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
9.5%
4/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.3%
3/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Papilloma viral infection
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Sinusitis
|
12.2%
5/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
14.3%
6/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
6.7%
3/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.4%
2/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Tonsillitis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Trichomoniasis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.4%
2/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
9.5%
4/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
14.3%
6/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
17.1%
7/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
22.2%
10/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Viral infection
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Infections and infestations
Wound infection
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Mountain sickness acute
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.3%
3/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Injury, poisoning and procedural complications
Vaginal laceration
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Investigations
Blood pressure increased
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Investigations
Smear cervix abnormal
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Investigations
Ureaplasma test positive
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Fibroadenoma of breast
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
7th nerve paralysis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Headache
|
12.2%
5/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
11.1%
5/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Migraine
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Psychiatric disorders
Depression
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Renal and urinary disorders
Cystitis interstitial
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Renal and urinary disorders
Dysuria
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Renal and urinary disorders
Micturition urgency
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Renal and urinary disorders
Urine odor abnormal
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Amenorrhea
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Dyspareunia
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Edema genital
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.4%
2/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Postmenopausal hemorrhage
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Uterine enlargement
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Uterine tenderness
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vaginal odor
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
7.3%
3/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.4%
2/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vulvovaginal disorder
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.8%
2/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.4%
2/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
7.1%
3/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Vascular disorders
Hypertension
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
4.9%
2/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.2%
1/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/42
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
2.4%
1/41
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
0.00%
0/45
Safety analyses were performed on the subjects in the safety population, which was defined as all subjects who were randomly assigned to VT-1161 or placebo and received at least 1 dose of study drug. Subjects were analyzed according to the treatment regimen received, regardless of the treatment regimen to which they were randomly assigned.
|
Additional Information
Sr Vice President, Clinical Development
Mycovia Pharmaceuticals
Phone: (919) 467-8539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Institution nor Principal Investigator shall publish the results of the Trial without the prior written consent of Sponsor, which it may withhold in its sole discretion.
- Publication restrictions are in place
Restriction type: OTHER