Trial Outcomes & Findings for A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults (NCT NCT00563368)
NCT ID: NCT00563368
Last Updated: 2015-03-30
Results Overview
Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
756 participants
Primary outcome timeframe
baseline to 28 weeks
Results posted on
2015-03-30
Participant Flow
Subject recruitment occurred at investigative sites in the US between November 2007 through January 2008
Participant milestones
| Measure |
Placebo
Placebo
|
PHEN 7.5 mg
7.5 mg phentermine
|
TPM 46 mg
46 mg topiramate
|
VI-0521 Mid
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
15 mg phentermine
|
TPM 92 mg
92 mg topiramate
|
VI-0521 Top
15 mg/92 mg phentermine/topiramate
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
109
|
108
|
107
|
108
|
107
|
108
|
|
Overall Study
COMPLETED
|
74
|
79
|
78
|
78
|
80
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
35
|
30
|
30
|
29
|
28
|
30
|
33
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
|
PHEN 7.5 mg
7.5 mg phentermine
|
TPM 46 mg
46 mg topiramate
|
VI-0521 Mid
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
15 mg phentermine
|
TPM 92 mg
92 mg topiramate
|
VI-0521 Top
15 mg/92 mg phentermine/topiramate
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
14
|
12
|
6
|
9
|
8
|
9
|
|
Overall Study
Adverse Event
|
3
|
4
|
5
|
9
|
6
|
10
|
17
|
|
Overall Study
Withdrawal by Subject
|
11
|
6
|
5
|
7
|
8
|
5
|
4
|
|
Overall Study
protocol non-compliance
|
1
|
1
|
2
|
1
|
0
|
1
|
3
|
|
Overall Study
Pregnancy
|
1
|
0
|
1
|
2
|
1
|
2
|
0
|
|
Overall Study
requirement for restricted medication
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
5
|
5
|
3
|
4
|
4
|
4
|
0
|
Baseline Characteristics
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=109 Participants
Placebo
|
PHEN 7.5 mg
n=109 Participants
7.5 mg phentermine
|
TPM 46 mg
n=108 Participants
46 mg topiramate
|
VI-0521 Mid
n=107 Participants
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
n=108 Participants
15 mg phentermine
|
TPM 92 mg
n=107 Participants
92 mg topiramate
|
VI-0521 Top
n=108 Participants
15 mg/92 mg phentermine/topiramate
|
Total
n=756 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 11.43 • n=39 Participants
|
46.4 years
STANDARD_DEVIATION 11.57 • n=41 Participants
|
46.9 years
STANDARD_DEVIATION 12.62 • n=35 Participants
|
44.6 years
STANDARD_DEVIATION 11.07 • n=31 Participants
|
45.7 years
STANDARD_DEVIATION 12.38 • n=146 Participants
|
45.8 years
STANDARD_DEVIATION 11.21 • n=19 Participants
|
44.6 years
STANDARD_DEVIATION 12.84 • n=147 Participants
|
45.6 years
STANDARD_DEVIATION 11.88 • n=193 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=39 Participants
|
86 Participants
n=41 Participants
|
86 Participants
n=35 Participants
|
85 Participants
n=31 Participants
|
86 Participants
n=146 Participants
|
85 Participants
n=19 Participants
|
85 Participants
n=147 Participants
|
599 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
22 Participants
n=19 Participants
|
23 Participants
n=147 Participants
|
157 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=39 Participants
|
109 participants
n=41 Participants
|
108 participants
n=35 Participants
|
107 participants
n=31 Participants
|
108 participants
n=146 Participants
|
107 participants
n=19 Participants
|
108 participants
n=147 Participants
|
756 participants
n=193 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 weeksPopulation: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)
Outcome measures
| Measure |
Placebo
n=103 Participants
Placebo
|
PHEN 7.5 mg
n=104 Participants
7.5 mg phentermine
|
TPM 46 mg
n=102 Participants
46 mg topiramate
|
VI-0521 Mid
n=103 Participants
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
n=106 Participants
15 mg phentermine
|
TPM 92 mg
n=105 Participants
92 mg topiramate
|
VI-0521 Top
n=103 Participants
15 mg/92 mg phentermine/topiramate
|
|---|---|---|---|---|---|---|---|
|
Percent Weight Loss From Baseline to Week 28
|
1.7 percent weight loss
Standard Error 0.61
|
5.5 percent weight loss
Standard Error 0.61
|
5.1 percent weight loss
Standard Error 0.61
|
8.5 percent weight loss
Standard Error 0.62
|
6.1 percent weight loss
Standard Error 0.61
|
6.4 percent weight loss
Standard Error 0.62
|
9.2 percent weight loss
Standard Error 0.61
|
PRIMARY outcome
Timeframe: baseline to 28 weeksPopulation: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
Outcome measures
| Measure |
Placebo
n=103 Participants
Placebo
|
PHEN 7.5 mg
n=104 Participants
7.5 mg phentermine
|
TPM 46 mg
n=102 Participants
46 mg topiramate
|
VI-0521 Mid
n=103 Participants
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
n=106 Participants
15 mg phentermine
|
TPM 92 mg
n=105 Participants
92 mg topiramate
|
VI-0521 Top
n=103 Participants
15 mg/92 mg phentermine/topiramate
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
|
15.5 percentage of participants
|
43.3 percentage of participants
|
39.2 percentage of participants
|
62.1 percentage of participants
|
46.2 percentage of participants
|
48.6 percentage of participants
|
66.0 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
PHEN 7.5 mg
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
TPM 46 mg
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
VI-0521 Mid
Serious events: 1 serious events
Other events: 84 other events
Deaths: 0 deaths
PHEN 15 mg
Serious events: 1 serious events
Other events: 88 other events
Deaths: 0 deaths
TPM 92 mg
Serious events: 1 serious events
Other events: 84 other events
Deaths: 0 deaths
VI-0521 Top
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=109 participants at risk
Placebo
|
PHEN 7.5 mg
n=109 participants at risk
7.5 mg phentermine
|
TPM 46 mg
n=106 participants at risk
46 mg topiramate
|
VI-0521 Mid
n=106 participants at risk
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
n=108 participants at risk
15 mg phentermine
|
TPM 92 mg
n=107 participants at risk
92 mg topiramate
|
VI-0521 Top
n=108 participants at risk
15 mg/92 mg phentermine/topiramate
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/108 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulia of vater
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Pelvic Mass
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
appendicitis
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Cardiac disorders
cardiac arrhythmia
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/107 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
chest pain
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/108 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Eye disorders
vision blurred
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/108 • Number of events 1 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
Other adverse events
| Measure |
Placebo
n=109 participants at risk
Placebo
|
PHEN 7.5 mg
n=109 participants at risk
7.5 mg phentermine
|
TPM 46 mg
n=106 participants at risk
46 mg topiramate
|
VI-0521 Mid
n=106 participants at risk
7.5 mg/46 mg phentermine/topiramate
|
PHEN 15 mg
n=108 participants at risk
15 mg phentermine
|
TPM 92 mg
n=107 participants at risk
92 mg topiramate
|
VI-0521 Top
n=108 participants at risk
15 mg/92 mg phentermine/topiramate
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
2.8%
3/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.8%
2/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.7%
6/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.0%
12/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.3%
9/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
12.3%
13/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
13.2%
14/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.3%
9/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
13.1%
14/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
13.0%
14/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
10.1%
11/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.5%
6/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
9.4%
10/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
9.3%
10/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.4%
9/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
10.2%
11/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
Influenza
|
4.6%
5/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.7%
6/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.7%
6/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Infections and infestations
Sinusitis
|
5.5%
6/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.7%
5/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.4%
8/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.7%
5/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.7%
4/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Fatigue
|
6.4%
7/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.5%
8/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.7%
6/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.5%
7/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
9.3%
10/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
General disorders
Irritability
|
1.8%
2/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.5%
6/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
5.5%
6/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.4%
7/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.8%
4/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
12.3%
13/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
11.1%
12/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.7%
5/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
10.2%
11/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
6/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.3%
9/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.8%
4/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.00%
0/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.4%
8/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Eye disorders
Vision blurred
|
4.6%
5/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.5%
6/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.5%
8/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.5%
7/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.5%
7/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
7/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.8%
2/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.8%
4/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.94%
1/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.3%
9/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
12.8%
14/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
12.8%
14/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.5%
8/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
15.1%
16/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
10.2%
11/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
10.3%
11/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
15.7%
17/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Paresthesia
|
3.7%
4/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
11.3%
12/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
17.0%
18/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
22.4%
24/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
23.1%
25/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.5%
9/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
14.8%
16/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
1.8%
2/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.8%
4/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.7%
4/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.3%
9/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Nervous system disorders
Disturbance in Attention
|
0.92%
1/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
1.9%
2/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.93%
1/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.7%
4/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.7%
4/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.3%
8/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
13.2%
14/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
12.0%
13/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.5%
7/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
18.5%
20/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
9/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.7%
4/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
6.6%
7/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.3%
9/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
15.7%
17/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
5/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.6%
5/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.5%
8/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
8.5%
9/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
4.7%
5/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
7.4%
8/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
4.6%
5/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
0.92%
1/109 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
2.8%
3/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.8%
4/106 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
3.7%
4/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/107 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
5.6%
6/108 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Only subjects who received at least one dose of study drug were included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
- Publication restrictions are in place
Restriction type: OTHER