Trial Outcomes & Findings for How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics (NCT NCT00667732)
NCT ID: NCT00667732
Last Updated: 2013-02-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
After 24 weeks of randomized treatment
Results posted on
2013-02-06
Participant Flow
Recruitment: March 2007 - February 2009 Participant source: medical clinics, local communities
There were 8 weeks of open-label exenatide use before enrollment into the randomized portion of the study to ensure patients ability to tolerate medication before adding insulin to the medication regimen.
Participant milestones
| Measure |
Run-In Group
All participants took exenatide twice daily in addition to their Metformin dose.
A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time.
|
Exenatide Group
After run-in participants were randomized to exenatide.
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
metformin: continued at same dose participant entered study on.
Lantus Insulin: titrated per protocol depending on blood sugar levels
In extension period, participants continued regular regimen with open label exenatide
|
Placebo Group
After run-in participants were randomized to placebo.
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
metformin: continued at same dose participant entered study on.
Lantus Insulin: titrated per protocol depending on blood sugar levels
In extension period, participants continued regular regimen with open label exenatide instead of placebo
|
|---|---|---|---|
|
Run -In (8 Weeks)
STARTED
|
41
|
0
|
0
|
|
Run -In (8 Weeks)
Participants Enrolled in Substudy
|
20
|
0
|
0
|
|
Run -In (8 Weeks)
COMPLETED
|
34
|
0
|
0
|
|
Run -In (8 Weeks)
NOT COMPLETED
|
7
|
0
|
0
|
|
Randomization (24 Weeks)
STARTED
|
0
|
17
|
17
|
|
Randomization (24 Weeks)
Participants Enrolled in Substudy
|
0
|
11
|
9
|
|
Randomization (24 Weeks)
COMPLETED
|
0
|
16
|
17
|
|
Randomization (24 Weeks)
NOT COMPLETED
|
0
|
1
|
0
|
|
Extension (26 Weeks)
STARTED
|
0
|
14
|
17
|
|
Extension (26 Weeks)
COMPLETED
|
0
|
14
|
17
|
|
Extension (26 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Run-In Group
All participants took exenatide twice daily in addition to their Metformin dose.
A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time.
|
Exenatide Group
After run-in participants were randomized to exenatide.
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
metformin: continued at same dose participant entered study on.
Lantus Insulin: titrated per protocol depending on blood sugar levels
In extension period, participants continued regular regimen with open label exenatide
|
Placebo Group
After run-in participants were randomized to placebo.
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
metformin: continued at same dose participant entered study on.
Lantus Insulin: titrated per protocol depending on blood sugar levels
In extension period, participants continued regular regimen with open label exenatide instead of placebo
|
|---|---|---|---|
|
Run -In (8 Weeks)
Adverse Event
|
4
|
0
|
0
|
|
Run -In (8 Weeks)
Withdrawal by Subject
|
3
|
0
|
0
|
|
Randomization (24 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Baseline characteristics by cohort
| Measure |
Exenatide Group
n=17 Participants
Participants will receive exenatide as part of their diabetes treatment
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
|
Placebo Group
n=17 Participants
Participants will receive placebo rather than exenatide as part of their diabetes treatment
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: After 24 weeks of randomized treatmentPopulation: Intent to treat. All participants randomized to treatment.
Outcome measures
| Measure |
Exenatide Group
n=17 Participants
Participants will receive exenatide as part of their diabetes treatment
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
|
Placebo Group
n=17 Participants
Participants will receive placebo rather than exenatide as part of their diabetes treatment
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
|
|---|---|---|
|
The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
|
47 percentage of participants
Interval 5.7 to 9.3
|
12 percentage of participants
Interval 5.7 to 9.8
|
SECONDARY outcome
Timeframe: After 24 weeks of randomized treatmentPopulation: Per protocol, all participants who completed treatment
efficacy criteria, 50% of per protocol participants reached A1c target of \<6.5%
Outcome measures
| Measure |
Exenatide Group
n=16 Participants
Participants will receive exenatide as part of their diabetes treatment
exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
|
Placebo Group
n=17 Participants
Participants will receive placebo rather than exenatide as part of their diabetes treatment
placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
|
|---|---|---|
|
The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
|
50 percentage of participants
0.27
|
12 percentage of participants
|
Adverse Events
Run-In Group
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Exenatide Randomization Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Randomization Period
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Exenatide Open-Label (Previous Exenatide)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Exenatide Open-Label (Previous Placebo)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Run-In Group
n=38 participants at risk
All participants took exenatide twice daily in addition to their Metformin dose.
|
Exenatide Randomization Group
n=17 participants at risk
After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
|
Placebo Randomization Period
n=17 participants at risk
After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
|
Exenatide Open-Label (Previous Exenatide)
n=14 participants at risk
Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
|
Exenatide Open-Label (Previous Placebo)
n=17 participants at risk
Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.2%
13/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
17.6%
3/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
14.3%
2/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
17.6%
3/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
4/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Stomach ache, upset
|
5.3%
2/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Heartburn, reflux
|
5.3%
2/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
diarrhea, loose stools
|
7.9%
3/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
21.4%
3/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Upper Respiratory Infection
|
5.3%
2/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
23.5%
4/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
17.6%
3/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
21.4%
3/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Hiatal Hernia
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Sour Taste
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Dental Work
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Gastroenteritis, stomach flu
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
23.5%
4/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Immune system disorders
Allergies
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Sinusitis
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Strep Throat
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Ear Infection
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Injury, poisoning and procedural complications
Left wrist sprain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Injury, poisoning and procedural complications
Left 5th toe fracture
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Injury, poisoning and procedural complications
Fall with bruised arm, leg
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Right Ankle Pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Right thumb pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Left foot pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Right and left shoulder pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Right ankle swelling
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
left toe swelling (gout)
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Left wrist pain and numbness
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Renal and urinary disorders
Elevated Creatinine
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
11.8%
2/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Respiratory, thoracic and mediastinal disorders
Lost voice
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Skin and subcutaneous tissue disorders
Injection site redness, itching
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Skin and subcutaneous tissue disorders
Left wrist pigmentation
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Eye disorders
Dry Eyes
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
14.3%
2/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
General disorders
Decreased energy
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Cold/flu
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
28.6%
4/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
17.6%
3/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Sore Throat
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Lymph node enlargement, cervical
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Paronychial infection, finger
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Infections and infestations
Cold sore, lip
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Injury, poisoning and procedural complications
Motor vehicle accident with facial laceration
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Rib Pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Arthritis, leg
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Musculoskeletal and connective tissue disorders
Aching elbows
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Numbness, arms, hands
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Carpal Tunnel syndrome
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Nervous system disorders
Ulnar neuropathy
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
58.8%
10/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
47.1%
8/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
57.1%
8/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
58.8%
10/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
|
Injury, poisoning and procedural complications
Fall with leg contusion
|
0.00%
0/38 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
0.00%
0/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
7.1%
1/14 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
5.9%
1/17 • Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.
All participants who received at least one dose of treatment during appropriate period
|
Additional Information
Dr. Matthew Riddle
Oregon Health and Science University
Phone: 503-494-0557
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60