Trial Outcomes & Findings for Augmenting Cognitive Training In Older Adults (NCT NCT02851511)
NCT ID: NCT02851511
Last Updated: 2024-04-17
Results Overview
Composite measure of cognitive ability as defined by NIH toolbox fluid cognition fully corrected T-score. Minimum change = -13, Maximum change = 26. Higher scores mean a better outcome. The minimum and maximum for Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation, Educational Training + Active Stimulation and Educational Training + Sham Stimulation are (-13, 20) and (-10, 26), respectively. This outcome is measured for the participants who received cognitive training, including both Phase I and Phase II participants, N=334 (Phase I N=42, Phase II N=292).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
379 participants
Primary outcome timeframe
Change from baseline to post assessment (3 months).
Results posted on
2024-04-17
Participant Flow
Participant flow is reported with three periods. Period 1 includes all randomized participants (combined Phase I and Phase II). Period 2 contains only the Phase I participants. Period 3 contains only the Phase II participants. In Phase II the two education training arms were eliminated, hence the allocation of 0 to those groups. Participants who were enrolled in Phase I education training were not randomized again in Phase II (there is no crossover).
Participant milestones
| Measure |
Cognitive Training + Active Stimulation
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
Educational Training + Active Stimulation
This arm receives educational training combined with active tDCS.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
Educational Training + Sham Stimulation
This arm receives educational training combined with sham tDCS.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
|---|---|---|---|---|
|
Overall (Phase I + Phase II)
STARTED
|
168
|
166
|
23
|
22
|
|
Overall (Phase I + Phase II)
COMPLETED
|
126
|
127
|
23
|
18
|
|
Overall (Phase I + Phase II)
NOT COMPLETED
|
42
|
39
|
0
|
4
|
|
Phase I
STARTED
|
21
|
21
|
23
|
22
|
|
Phase I
COMPLETED
|
19
|
20
|
23
|
18
|
|
Phase I
NOT COMPLETED
|
2
|
1
|
0
|
4
|
|
Phase II
STARTED
|
147
|
145
|
0
|
0
|
|
Phase II
COMPLETED
|
107
|
107
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
40
|
38
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cognitive Training + Active Stimulation
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
Educational Training + Active Stimulation
This arm receives educational training combined with active tDCS.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
Educational Training + Sham Stimulation
This arm receives educational training combined with sham tDCS.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
|---|---|---|---|---|
|
Overall (Phase I + Phase II)
Physician Decision
|
18
|
16
|
0
|
1
|
|
Overall (Phase I + Phase II)
Withdrawal by Subject
|
20
|
17
|
0
|
3
|
|
Overall (Phase I + Phase II)
COVID-19 lockdown, no reason specified
|
4
|
5
|
0
|
0
|
|
Overall (Phase I + Phase II)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Phase I
Physician Decision
|
0
|
0
|
0
|
1
|
|
Phase I
Withdrawal by Subject
|
2
|
1
|
0
|
3
|
|
Phase II
Physician Decision
|
18
|
16
|
0
|
0
|
|
Phase II
Withdrawal by Subject
|
18
|
16
|
0
|
0
|
|
Phase II
COVID-19 lockdown, no reason specified
|
4
|
5
|
0
|
0
|
|
Phase II
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Augmenting Cognitive Training In Older Adults
Baseline characteristics by cohort
| Measure |
Cognitive Training + Active Stimulation
n=168 Participants
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
n=166 Participants
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
Educational Training + Active Stimulation
n=23 Participants
This arm receives educational training combined with active tDCS.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
Educational Training + Sham Stimulation
n=22 Participants
This arm receives educational training combined with sham tDCS.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
Total
n=379 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
71.5 years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
70.0 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
73.1 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 5.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
236 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
143 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
354 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
332 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=99 Participants
|
166 participants
n=107 Participants
|
23 participants
n=206 Participants
|
22 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Years of Education
|
16.3 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
16.4 years
STANDARD_DEVIATION 2.4 • n=107 Participants
|
16.7 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
15.6 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
16.3 years
STANDARD_DEVIATION 2.4 • n=31 Participants
|
|
MOCA Total Score
|
26.7 units on a scale
STANDARD_DEVIATION 2.0 • n=99 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 1.9 • n=107 Participants
|
26.9 units on a scale
STANDARD_DEVIATION 1.7 • n=206 Participants
|
26.1 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
26.7 units on a scale
STANDARD_DEVIATION 1.9 • n=31 Participants
|
|
Average POSIT z-score:
|
-0.18 z-score
STANDARD_DEVIATION 0.44 • n=99 Participants
|
-0.20 z-score
STANDARD_DEVIATION 0.46 • n=107 Participants
|
-0.11 z-score
STANDARD_DEVIATION 0.47 • n=206 Participants
|
-0.44 z-score
STANDARD_DEVIATION 0.55 • n=7 Participants
|
-0.20 z-score
STANDARD_DEVIATION 0.46 • n=31 Participants
|
|
BDI-II Total Score
|
4.0 units on a scale
STANDARD_DEVIATION 4.8 • n=99 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 3.9 • n=107 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 3.1 • n=206 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 4.3 • n=31 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to post assessment (3 months).Composite measure of cognitive ability as defined by NIH toolbox fluid cognition fully corrected T-score. Minimum change = -13, Maximum change = 26. Higher scores mean a better outcome. The minimum and maximum for Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation, Educational Training + Active Stimulation and Educational Training + Sham Stimulation are (-13, 20) and (-10, 26), respectively. This outcome is measured for the participants who received cognitive training, including both Phase I and Phase II participants, N=334 (Phase I N=42, Phase II N=292).
Outcome measures
| Measure |
Cognitive Training + Active Stimulation
n=168 Participants
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
n=166 Participants
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
|---|---|---|
|
Improvement in Cognitive Ability.
|
4.7 units on a scale
Standard Deviation 6.5
|
4.5 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline to post assessment (3 months).Population: Adults were between the ages of 65-89, right-handed, fluent in English, and had evidence of age-related cognitive decline. Analysis includes all 87 participants from Phase I.
POSIT BrainHQ Cognitive Training Composite Performance measure involves performance on the 8 selected cognitive training tasks set to the medium difficulty level and provides a measure of proximal performance on cognitive training tasks central to the cognitive training condition. The higher score indicates better performance. The range of POSIT Z-Score at 3-month is -1.04 to 1.75. the minimum and maximum for Cognitive training group and Education training group are (-0.24, 1.75) and (-1.04, 1.39), respectively.
Outcome measures
| Measure |
Cognitive Training + Active Stimulation
n=42 Participants
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
n=45 Participants
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
|---|---|---|
|
Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)
|
0.95 units on a scale
Standard Deviation 0.41
|
-0.06 units on a scale
Standard Deviation 0.47
|
Adverse Events
Cognitive Training + Active Stimulation
Serious events: 16 serious events
Other events: 69 other events
Deaths: 0 deaths
Cognitive Training + Sham Stimulation
Serious events: 19 serious events
Other events: 75 other events
Deaths: 0 deaths
Educational Training + Active Stimulation
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Educational Training + Sham Stimulation
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Training + Active Stimulation
n=168 participants at risk
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
n=166 participants at risk
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
Educational Training + Active Stimulation
n=23 participants at risk
This arm receives educational training combined with active tDCS.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
Educational Training + Sham Stimulation
n=22 participants at risk
This arm receives educational training combined with sham tDCS.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
|---|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Accidentally swallowed non food item
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Anterior and posterior surgery (pelvic floor)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Bleeding
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Renal and urinary disorders
Blood Loss
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Infections and infestations
Bowel infection
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Broken finger
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Infections and infestations
Cat bite
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Cut on cheek (stiches)
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Cyst removal
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Dislocated Shoulder
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Esophageal cancer
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Eye injury
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Fall
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Fall (fractured finger)
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Fecal blockage
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Finger injury
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Hernia
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Herniated disc repair
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Infections and infestations
Infection from Knee Replacement
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Infections and infestations
Infection from skin wound
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Intestinal Bleeding
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Reproductive system and breast disorders
Prostate Cancer
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Rapid heartbeat (ER visit)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Shortness of Breath, tunnel vision, lost continence (ER visit)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer spot removal
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Stitches
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Stomach bleeding
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Stomach pain
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Tachycardia
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Vascular disorders
Torn artery
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Vascular disorders
Transient ischemic attack
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Renal and urinary disorders
Urine retention
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Nervous system disorders
Vertigo
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
Other adverse events
| Measure |
Cognitive Training + Active Stimulation
n=168 participants at risk
This arm receives cognitive training combined with active tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
|
Cognitive Training + Sham Stimulation
n=166 participants at risk
This arm receives cognitive training combined with sham tDCS.
Cognitive Training: Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
|
Educational Training + Active Stimulation
n=23 participants at risk
This arm receives educational training combined with active tDCS.
tDCS (active stimulation): A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
Educational Training + Sham Stimulation
n=22 participants at risk
This arm receives educational training combined with sham tDCS.
tDCS (sham stimulation): Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational Training: Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Actinic Keratoses
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Psychiatric disorders
Anxiety
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Psychiatric disorders
Anxiety and Depression
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.8%
8/168 • Number of events 12 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.8%
8/166 • Number of events 10 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
9.1%
2/22 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Back pain (urgent care visit)
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Psychiatric disorders
Bipolar Disorder Treatment
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Renal and urinary disorders
Bladder infection
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Metabolism and nutrition disorders
Bone fusion of finger
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Bone spur (foot)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Bone spurs on knees
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Broken bone in hand from fall
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Broken wrist
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Bruised rib
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Infections and infestations
COVID-19
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Cataract surgery
|
6.0%
10/168 • Number of events 11 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
3.6%
6/166 • Number of events 7 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Cataracts
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Chest Pain
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Chest pain (caused by esophogeal gastritis and hiatal hernia)
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Colonoscopy
|
1.8%
3/168 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Nervous system disorders
Concussion
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Conjunctivitis
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Cough / Allergies
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Cut on head
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Psychiatric disorders
Depression
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Dizziness
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Reproductive system and breast disorders
Enlarged prostate
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Eye hemorrhage
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Eye injury
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Eyelid surgery
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Nervous system disorders
Fainting
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Fainting (post blood draw unrelated to study)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Fall
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Fall (hit front of head)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Finger numbness
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Food poisoning
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Foot Injury
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Fractured hand
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Nervous system disorders
Headache
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Ear and labyrinth disorders
Hearing impairment
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Ear and labyrinth disorders
Hearing loss
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Heart Ablation
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Heart Murmur
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Heart palpitations
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Heat Exhaustion
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Hernia
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
High Blood Pressure
|
3.6%
6/168 • Number of events 6 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
High Cholesterol
|
1.8%
3/168 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.2%
7/166 • Number of events 7 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
High blood pressure and low heart rate
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Hip Replacement
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Hip injury
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Endocrine disorders
Hypothyroidism
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney Cyst
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Knee and hip pain
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Knee injury
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Larynopharyngeal reflux
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Metabolism and nutrition disorders
Low Iron
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Nervous system disorders
Migraine headache
|
3.6%
6/168 • Number of events 9 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
6.0%
10/166 • Number of events 14 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Infections and infestations
Mononucleosis
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Nasal Drip
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/168 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
General disorders
Nausea and Dizziness
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.2%
2/166 • Number of events 2 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Neck Injury from car accident
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Oral surgery
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
1.8%
3/166 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Psychiatric disorders
PTSD & Increased Anxiety
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Posterior Vitreous Detachment
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Protruding Disc (L5)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Radio ablation
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Skin biopsy
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Skin cancer spot removal
|
11.3%
19/168 • Number of events 23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
14.5%
24/166 • Number of events 31 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
17.4%
4/23 • Number of events 5 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
13.6%
3/22 • Number of events 4 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis & Sciatica
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Stents
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Stress fracture (fibula)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Eye disorders
Sty
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Cardiac disorders
Tachycardia
|
1.2%
2/168 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.5%
1/22 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Vascular disorders
Thoracic Aortic Aneurysm
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.8%
3/168 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
5.4%
9/166 • Number of events 10 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
4.3%
1/23 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
13.6%
3/22 • Number of events 3 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Urolift implant (Enlarged Prostate treatment)
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Varithena Ablation
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Varithena treatment
|
0.60%
1/168 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/166 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Nervous system disorders
Vertigo
|
2.4%
4/168 • Number of events 4 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Wrist pain
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
|
Surgical and medical procedures
Wrist surgery
|
0.00%
0/168 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.60%
1/166 • Number of events 1 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/23 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
0.00%
0/22 • The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.
Adverse events were queried using medical history questionnaires at baseline, 3 month post test, and 1 follow-up assessment visits. If adverse events were self reported by participants between assessment visits a standardized adverse event form was completed to assess severity, relatedness, and outcome.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place