Trial Outcomes & Findings for A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787) (NCT NCT00796367)
NCT ID: NCT00796367
Last Updated: 2012-09-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
676 participants
Primary outcome timeframe
From baseline to end of treatment
Results posted on
2012-09-10
Participant Flow
Subjects were from OB-303 (NCT00553787)
Participant milestones
| Measure |
Placebo
Placebo
|
VI-0521 Mid
VI-0521 7.5 mg PHEN/46 mg TPM
|
VI-0521 Top
VI-0521 15 mg PHEN/92 mg TPM
|
|---|---|---|---|
|
Overall Study
STARTED
|
227
|
154
|
295
|
|
Overall Study
COMPLETED
|
197
|
129
|
248
|
|
Overall Study
NOT COMPLETED
|
30
|
25
|
47
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
|
VI-0521 Mid
VI-0521 7.5 mg PHEN/46 mg TPM
|
VI-0521 Top
VI-0521 15 mg PHEN/92 mg TPM
|
|---|---|---|---|
|
Overall Study
other
|
2
|
4
|
3
|
|
Overall Study
Adverse Event
|
6
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
21
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
12
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
|
Overall Study
non compliance
|
3
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
1
|
|
Overall Study
Requirement for restricted medication
|
2
|
0
|
2
|
Baseline Characteristics
A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
Baseline characteristics by cohort
| Measure |
Placebo
n=227 Participants
Placebo
|
VI-0521 Mid
n=153 Participants
VI-0521 7.5 mg PHEN/46 mg TPM
|
VI-0521 Top
n=295 Participants
VI-0521 15 mg PHEN/92 mg TPM
|
Total
n=675 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
52.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
448 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
227 participants
n=5 Participants
|
153 participants
n=7 Participants
|
295 participants
n=5 Participants
|
675 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatmentPopulation: Intent-to-Treat Last observation carried forward (ITT-LOCF)
Outcome measures
| Measure |
Placebo
n=227 Participants
Placebo
|
VI-0521 Mid
n=153 Participants
VI-0521 7.5 mg phentermine/46 mg topiramate
|
VI-0521 Top
n=295 Participants
VI-0521 15 mg phentermine/92 mg topiramate
|
|---|---|---|---|
|
Percent Weight Change at End of Treatment, Week 108.
|
-1.8 percent weight loss
Standard Error 0.55
|
-9.32 percent weight loss
Standard Error 0.67
|
-10.5 percent weight loss
Standard Error 0.5
|
PRIMARY outcome
Timeframe: Baseline to End of TreatmentPopulation: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
Outcome measures
| Measure |
Placebo
n=227 Participants
Placebo
|
VI-0521 Mid
n=153 Participants
VI-0521 7.5 mg phentermine/46 mg topiramate
|
VI-0521 Top
n=295 Participants
VI-0521 15 mg phentermine/92 mg topiramate
|
|---|---|---|---|
|
Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
|
30 percent participants
|
75.2 percent participants
|
79.3 percent participants
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 182 other events
Deaths: 0 deaths
VI-0521 Mid
Serious events: 4 serious events
Other events: 111 other events
Deaths: 0 deaths
VI-0521 Top
Serious events: 13 serious events
Other events: 234 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=227 participants at risk
Placebo
|
VI-0521 Mid
n=153 participants at risk
VI-0521 7.5 mg PHEN/46 mg TPM
|
VI-0521 Top
n=295 participants at risk
VI-0521 15 mg PHEN/92 mg TPM
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
humerus fracture
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
hemorrhage intracranial
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
transient ischemic attack
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
ischemic stroke
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
depression
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
peptic ulcer hemorrhage
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
inguinal hernia, obstructive
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
abdominal hernia
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Renal and urinary disorders
nephritic syndrome
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Renal and urinary disorders
renal failure, acute
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.68%
2/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
pneumonia
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
appendicitis
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.68%
2/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
pyelonephritis
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
influenza
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
mesothelioma
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Vascular disorders
hypotension
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Immune system disorders
drug hypersensitivity
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.68%
2/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
General disorders
serositis
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Hepatobiliary disorders
cholecystitis
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Hepatobiliary disorders
acute cholecystitis
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Reproductive system and breast disorders
uterine prolapse
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Reproductive system and breast disorders
benign prostatic hyperplasia
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Reproductive system and breast disorders
cervical dysplasia
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
Other adverse events
| Measure |
Placebo
n=227 participants at risk
Placebo
|
VI-0521 Mid
n=153 participants at risk
VI-0521 7.5 mg PHEN/46 mg TPM
|
VI-0521 Top
n=295 participants at risk
VI-0521 15 mg PHEN/92 mg TPM
|
|---|---|---|---|
|
Infections and infestations
upper respiratory tract infection
|
18.5%
42/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
17.0%
26/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
15.3%
45/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
nasopharyngitis
|
11.5%
26/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
8.5%
13/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
8.8%
26/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
sinusitis
|
7.9%
18/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
7.8%
12/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.5%
28/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
urinary tract infection
|
5.7%
13/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
9.2%
14/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
6.1%
18/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
influenza
|
3.5%
8/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
6.5%
10/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
6.4%
19/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
bronchitis
|
3.1%
7/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
5.2%
8/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.4%
10/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
constipation
|
3.1%
7/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
7.2%
11/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.1%
12/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
nausea
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
6.5%
10/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.4%
4/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
6.2%
14/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.6%
7/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
5.4%
16/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.1%
7/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
5.9%
9/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
5.1%
15/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
insomnia
|
3.5%
8/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
5.9%
9/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.7%
11/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
procedural pain
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
5.2%
8/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.7%
14/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
4.8%
11/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.8%
11/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.7%
5/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
6/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.3%
2/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.1%
9/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
gastroenteritis viral
|
2.6%
6/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.4%
4/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
ear infection
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.4%
7/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
tooth abscess
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.4%
4/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
pneumonia
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.0%
3/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
viral infection
|
1.3%
3/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.3%
2/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
tooth infection
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.4%
4/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Infections and infestations
oral herpes
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.68%
2/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
2.2%
5/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.4%
7/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
2.2%
5/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
diarrhea
|
1.3%
3/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.7%
11/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
tooth ache
|
2.2%
5/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.68%
2/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
abdominal pain
|
2.2%
5/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.0%
3/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
hemorrhoids
|
0.44%
1/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
vomiting
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
joint sprain
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.3%
5/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.4%
7/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
muscle strain
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.9%
6/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Injury, poisoning and procedural complications
contusion
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.4%
7/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.8%
4/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.4%
10/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
2.6%
6/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.7%
8/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
2.6%
6/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.0%
3/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
headache
|
2.6%
6/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.1%
12/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Nervous system disorders
paresthesia
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.4%
10/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
depression
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.4%
10/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Psychiatric disorders
anxiety
|
1.3%
3/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
3.1%
7/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.65%
1/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.0%
3/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Metabolism and nutrition disorders
dyslipidemia
|
2.6%
6/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.3%
2/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Investigations
weight increased
|
2.2%
5/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.4%
7/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Investigations
hemoglobin decreased
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Investigations
abdominal bruit
|
0.00%
0/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.34%
1/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
General disorders
edema peripheral
|
3.1%
7/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
0.00%
0/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
4.1%
12/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Eye disorders
eye pain
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.6%
4/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.4%
4/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Vascular disorders
hypertension
|
4.0%
9/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
1.3%
2/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
3.4%
10/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
|
Immune system disorders
seasonal allergy
|
0.88%
2/227 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
3/153 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
2.0%
6/295 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
|
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