Trial Outcomes & Findings for Translational Neuroscience Optimization of GlyT1 Inhibitor (NCT NCT01911676)
NCT ID: NCT01911676
Last Updated: 2024-08-19
Results Overview
To test the efficacy of PF-03463275 on cognitive test performance specifically, the MCCB composite score was used. The MCCB consists of 10 tests and provides standard scores and percentiles for each of seven cognitive domains and an overall composite score. Domains assessed include: speed of processing, attention/vigilance, working memory (verbal and visual), verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB overall composite score is presented as a T-score. The range of T-scores is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm.
Results posted on
2024-08-19
Participant Flow
Subjects will be randomized to one of two doses of PF-03463275 and placebo twice daily for 2 treatment periods each lasting approx 5 weeks. Treatment periods will be separated by a washout period lasting approx 3 weeks. The 4 possible study arms are as follows: A) Pd 1: Active dose 60mg PF-03463275 then Pd 2: Placebo B) Pd 1: Active dose 40mg PF-03463275 then Pd 2: Placebo C) Pd 1: Placebo then Pd 2: Active dose 60mg PF-03463275 D) Pd 1: Placebo 40mg PF-03463275 then Pd 2: Placebo.
Participant milestones
| Measure |
PF-03463275 Active Dose #1
Subjects randomized to this arm will receive the following: Period 1) Active dose 60mg PF-03463275, then Period 2) Placebo.
|
PF-03463275 Active Dose #2
Subjects randomized to this arm will receive the following: Period 1) Active dose 40mg PF-03463275, then Period 2) Placebo.
|
Placebo, Active Dose #1
Subjects randomized to this arm will receive the following: Period 1) Placebo, then Period 2) Active Dose 60mg PF-03463275.
|
Placebo, Active Dose #2
Subjects randomized to this arm will receive the following: Period 1) Placebo, then Period 2) Active Dose 40mg PF-03463275.
|
|---|---|---|---|---|
|
Period 1 of Study
STARTED
|
23
|
23
|
12
|
13
|
|
Period 1 of Study
COMPLETED
|
17
|
21
|
11
|
10
|
|
Period 1 of Study
NOT COMPLETED
|
6
|
2
|
1
|
3
|
|
Period 2 of Study
STARTED
|
17
|
21
|
11
|
10
|
|
Period 2 of Study
COMPLETED
|
15
|
21
|
11
|
8
|
|
Period 2 of Study
NOT COMPLETED
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
PF-03463275 Active Dose #1
Subjects randomized to this arm will receive the following: Period 1) Active dose 60mg PF-03463275, then Period 2) Placebo.
|
PF-03463275 Active Dose #2
Subjects randomized to this arm will receive the following: Period 1) Active dose 40mg PF-03463275, then Period 2) Placebo.
|
Placebo, Active Dose #1
Subjects randomized to this arm will receive the following: Period 1) Placebo, then Period 2) Active Dose 60mg PF-03463275.
|
Placebo, Active Dose #2
Subjects randomized to this arm will receive the following: Period 1) Placebo, then Period 2) Active Dose 40mg PF-03463275.
|
|---|---|---|---|---|
|
Period 1 of Study
Withdrawal by Subject
|
4
|
2
|
1
|
2
|
|
Period 1 of Study
Physician Decision
|
2
|
0
|
0
|
1
|
|
Period 2 of Study
Physician Decision
|
2
|
0
|
0
|
1
|
|
Period 2 of Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Translational Neuroscience Optimization of GlyT1 Inhibitor
Baseline characteristics by cohort
| Measure |
PF-03463275 Active Dose #1
n=23 Participants
Subjects randomized to this arm will receive the following: Period 1) Active dose 60mg PF-03463275, then Period 2) Placebo.
|
PF-03463275 Active Dose #2
n=23 Participants
Subjects randomized to this arm will receive the following: Period 1) Active dose 40mg PF-03463275, then Period 2) Placebo.
|
Placebo, Active Dose #1
n=12 Participants
Subjects randomized to this arm will receive the following: Period 1) Placebo, then Period 2) Active dose 60mg PF-03463275.
|
Placebo, Active Dose #2
n=13 Participants
Subjects randomized to this arm will receive the following: Period 1) Placebo, then Period 2) Active dose 40mg PF-03463275.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
45.4 years
n=5 Participants
|
49.6 years
n=7 Participants
|
50.92 years
n=5 Participants
|
39.77 years
n=4 Participants
|
46.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm.Population: The 3 arms that subjects can be randomized to are: A) Period 1: Active 60mg PF-03463275 then Period 2: Placebo; B) Period 1: Active 40mg PF-03463275 then Period 2: Placebo; C) Period 1: Placebo then Period 2: Active 60mg or 40mg PF-03463275. The following completed both period 1 and period 2 of the study: A) 15 subjects; B) 21 subjects; and C) 18 subjects (11 randomized to period 1-placebo/period 2-60mg PF-03463275; and 8 randomized to period 1-placebo/period 2-40mg PF-03463275).
To test the efficacy of PF-03463275 on cognitive test performance specifically, the MCCB composite score was used. The MCCB consists of 10 tests and provides standard scores and percentiles for each of seven cognitive domains and an overall composite score. Domains assessed include: speed of processing, attention/vigilance, working memory (verbal and visual), verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB overall composite score is presented as a T-score. The range of T-scores is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning.
Outcome measures
| Measure |
PF-03463275 Active Dose #1
n=15 Participants
Period 1: Active dose 60mg PF-03463275
Period 2: Placebo
|
PF-03463275 Active Dose #2
n=21 Participants
Period 1: Active dose 40mg PF-03463275
Period 2: Placebo
|
Placebo, Active Dose #1
n=11 Participants
Period 1: Placebo
Period 2: Active dose 60mg PF-03463275
|
Placebo, Active Dose #2
n=8 Participants
Period 1: Placebo
Period 2: Active dose 40mg PF-03463275
|
|---|---|---|---|---|
|
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Pre-Dose Period 1
|
28.15 score on scale
Standard Deviation 13.54
|
25.22 score on scale
Standard Deviation 13.86
|
31.71 score on scale
Standard Deviation 17.24
|
28.3 score on scale
Standard Deviation 17.7
|
|
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Post-Dose Period 1
|
29.25 score on scale
Standard Deviation 12.38
|
26.33 score on scale
Standard Deviation 14.96
|
30.86 score on scale
Standard Deviation 17.45
|
30.11 score on scale
Standard Deviation 14.75
|
|
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Pre-Dose Period 2
|
29.39 score on scale
Standard Deviation 12.68
|
27.11 score on scale
Standard Deviation 12.46
|
32.86 score on scale
Standard Deviation 18.52
|
31.8 score on scale
Standard Deviation 16.5
|
|
Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
Post-Dose Period 2
|
31.84 score on scale
Standard Deviation 13.36
|
28.21 score on scale
Standard Deviation 11.49
|
34.29 score on scale
Standard Deviation 18.88
|
32.2 score on scale
Standard Deviation 16.01
|
SECONDARY outcome
Timeframe: Change from Baseline at approximately 1 weekPopulation: Noncompleters and unusable data of completers led to differences between the total number of participants and the sample for this outcome measure.
To determine whether PF-03463275 impacts symptom domain scores and visual event related potentials (ERPs), analogous to long-term potentiation (LTP) with PF-03463275 treatment. A more positive value reflects a better outcome - there is no established range to report. A Z-score of 0 indicates the mean score. A positive z-score indicates the mean is higher than average.
Outcome measures
| Measure |
PF-03463275 Active Dose #1
n=14 Participants
Period 1: Active dose 60mg PF-03463275
Period 2: Placebo
|
PF-03463275 Active Dose #2
n=18 Participants
Period 1: Active dose 40mg PF-03463275
Period 2: Placebo
|
Placebo, Active Dose #1
n=9 Participants
Period 1: Placebo
Period 2: Active dose 60mg PF-03463275
|
Placebo, Active Dose #2
n=6 Participants
Period 1: Placebo
Period 2: Active dose 40mg PF-03463275
|
|---|---|---|---|---|
|
Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
Pre-Dose Period 1
|
-0.169 Mean LTP Standard (z) Score +1 SE
Standard Error 0.221
|
0.084 Mean LTP Standard (z) Score +1 SE
Standard Error 0.224
|
-0.629 Mean LTP Standard (z) Score +1 SE
Standard Error 0.267
|
-0.111 Mean LTP Standard (z) Score +1 SE
Standard Error 0.456
|
|
Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
Post-Dose Period 1
|
-0.544 Mean LTP Standard (z) Score +1 SE
Standard Error 0.281
|
-0.013 Mean LTP Standard (z) Score +1 SE
Standard Error 0.188
|
0.228 Mean LTP Standard (z) Score +1 SE
Standard Error 0.221
|
0.606 Mean LTP Standard (z) Score +1 SE
Standard Error 0.300
|
|
Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
Pre-Dose Period 2
|
-0.008 Mean LTP Standard (z) Score +1 SE
Standard Error 0.323
|
0.473 Mean LTP Standard (z) Score +1 SE
Standard Error 0.182
|
-0.614 Mean LTP Standard (z) Score +1 SE
Standard Error 0.398
|
0.127 Mean LTP Standard (z) Score +1 SE
Standard Error 0.443
|
|
Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
Post-Dose Period 2
|
-0.129 Mean LTP Standard (z) Score +1 SE
Standard Error 0.150
|
0.594 Mean LTP Standard (z) Score +1 SE
Standard Error 0.316
|
-0.674 Mean LTP Standard (z) Score +1 SE
Standard Error 0.313
|
0.915 Mean LTP Standard (z) Score +1 SE
Standard Error 0.421
|
Adverse Events
PF-03463275 Active Dose #1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-03463275 Active Dose #2
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Washout
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-03463275 Active Dose #1
n=34 participants at risk
AEs while taking PF-03463275 Active Dose #1
|
PF-03463275 Active Dose #2
n=33 participants at risk
AEs while taking PF-03463275 Active Dose #2
|
Placebo
n=63 participants at risk
AEs while taking Placebo
|
Washout
n=59 participants at risk
AEs while in the washout period (no medication)
|
|---|---|---|---|---|
|
Social circumstances
Hospitalization from Intent to Overdose on Meds / Suicidal Ideation
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Hospitalization Due to Stroke
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
Other adverse events
| Measure |
PF-03463275 Active Dose #1
n=34 participants at risk
AEs while taking PF-03463275 Active Dose #1
|
PF-03463275 Active Dose #2
n=33 participants at risk
AEs while taking PF-03463275 Active Dose #2
|
Placebo
n=63 participants at risk
AEs while taking Placebo
|
Washout
n=59 participants at risk
AEs while in the washout period (no medication)
|
|---|---|---|---|---|
|
Psychiatric disorders
Increased Anxiety
|
5.9%
2/34 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.2%
2/63 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Blurry Vision
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
6.1%
2/33 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.2%
2/63 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Sleep Disturbance
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
6.1%
2/33 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
6.3%
4/63 • Number of events 4 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Hand Tremor
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Lightheadedness
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Cardiac disorders
High Blood Pressure
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Sprained Ankle
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Renal and urinary disorders
Foul Smelling Odor in Urine
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Bell's Palsy
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Headache
|
8.8%
3/34 • Number of events 4 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
9.1%
3/33 • Number of events 3 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.2%
2/63 • Number of events 4 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.4%
2/59 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Gastrointestinal disorders
GI Discomfort
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Dizziness
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.4%
2/59 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.2%
2/63 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Bruised Forearms
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Cardiac disorders
Elevated AST/ALT
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Dry Cough
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Strain
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Hot Flashes
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Gastrointestinal disorders
Reduced Appetite
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Whiplash
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Vertigo
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Cardiac disorders
Orthostatic Hypotension
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Common Cold
|
8.8%
3/34 • Number of events 3 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
8.5%
5/59 • Number of events 5 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Tooth Pulled
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Stomach Cramps/Discomfort
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
6.1%
2/33 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Foot Injury
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Increased Sleep
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
4.8%
3/63 • Number of events 3 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Gastrointestinal disorders
Nausea / Vomiting
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
6.3%
4/63 • Number of events 4 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
5.1%
3/59 • Number of events 3 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Laryngitis
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Vasovagal Response
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Hyperglycemia
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Fatigue
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Dehydration
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Increase in Pain as a Result of Spinal Surgery Prior to Study
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Psychiatric disorders
Suicidal Ideation Due to Psychosocial Stressors
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Reduced Sleep
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Upper Respiratory Infection
|
2.9%
1/34 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Pharyngeal Pain
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Increased Appetite
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
4.8%
3/63 • Number of events 3 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Increase in Pre-Existing Headache
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Productive Cough / Chest Congestion
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Increase in Fibromyalgia Pain
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Eye Sensitivity
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Intermittent Blurred Vision
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Paronychia (Right Middle Finger)
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Psychiatric disorders
Low Mood
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Renal and urinary disorders
Increased Urination
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.4%
2/59 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Decreased Sleep (Associated with Pre-Existing Sleep Apnea)
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Gastrointestinal disorders
Increased Discomfort Associated with Pre-Existing Constipation
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Acute Ear Pain
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Intermittent Dental Pain
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Gum Soreness (at site of tooth extraction)
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Throat Pain
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Sore Shoulder
|
2.9%
1/34 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Cold Symptoms
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis on Forehead
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Stiffness
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
6.1%
2/33 • Number of events 2 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Light Sensitivity
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Hip Pain (associated with pre-existing bone spur)
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Pneumonia in Right Lung
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
3.0%
1/33 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Sinus Congestion
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.6%
1/63 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/59 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Wrist Drop / Radial Nerve Palsy
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
|
General disorders
Front Tooth Pain
|
0.00%
0/34 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/33 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
0.00%
0/63 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
1.7%
1/59 • Number of events 1 • Adverse events were captured from the time at which the participant signed consent throughout their completion in the study (follow up visit after the completion of period 2), over a time period of approximately 4 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place