Trial Outcomes & Findings for A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis (NCT NCT01918800)

NCT ID: NCT01918800

Last Updated: 2018-07-26

Results Overview

The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 282 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2018-07-26

Participant Flow

Participant milestones

Measure	Fatigue: Take Control Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Overall Study STARTED	109	109
Overall Study COMPLETED	100	104
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

Baseline characteristics by cohort

Measure	Fatigue: Take Control n=109 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=109 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.	Total n=218 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	98 Participants n=5 Participants	96 Participants n=7 Participants	194 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 9.8 • n=5 Participants	53.6 years STANDARD_DEVIATION 10.5 • n=7 Participants	53.7 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	77 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	80 Participants n=7 Participants	165 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	109 participants n=7 Participants	218 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.

Outcome measures

Measure	Fatigue: Take Control n=109 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=109 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Modified Fatigue Impact Scale	46.1 units on a scale Standard Deviation 12.2	46.7 units on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: 4 months

The self-report, retrospective MSSE is an 18-item scale of self-efficacy specifically designed for MS patients. This easy to use self-report measure demonstrates internal consistency estimates of about .89 for the full scale and a .75 test-retest correlation. Higher scores on the MSSE indicate higher self-efficacy. Scores range from 180-1800.

Outcome measures

Measure	Fatigue: Take Control n=109 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=109 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Multiple Sclerosis Self Efficacy Scale	1434.5 units on a scale Standard Deviation 274.2	1352.5 units on a scale Standard Deviation 241.4

SECONDARY outcome

Timeframe: 4 months

The self-report, retrospective BDI-II is a validated 21-item self-report measure of depression widely used in MS studies . Each item is scored between 0 and 3. It is reported to have good reliability (Cronbach's alpha of .81) and validity. Assessing for depression is part of the inclusion/exclusion criteria. Excluding subjects with severe depression is necessary to avoid confounding effects of fatigue and depression. Score range (0-63). Higher scores indicate greater depression.

Outcome measures

Measure	Fatigue: Take Control n=109 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=109 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Beck Depression Inventory II (BDI-II)	9.5 units on a scale Standard Deviation 7.7	10.7 units on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: 4 months

The SF-36 is a validated measure of health-related quality of life. It is sensitive to change, has appropriate psychometric properties and is frequently used in MS studies. Measures of health-related quality of life are recommended in the systematic review of self-management in neurological disorders. The range for the physical component score is 13.6-61.9. The range for the mental component scores is 15.6-70.0.

Outcome measures

Measure	Fatigue: Take Control n=100 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=104 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
SF-36 Physical Composite Score	24.5 units on a scale Standard Deviation 1.1	24.3 units on a scale Standard Deviation 1.1
SF-36 Mental Composite Score	23.9 units on a scale Standard Deviation 1.7	23.8 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 4 months

The self-report, retrospective Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults. A tool for older adults will be easy to use for people with MS who may not be regular exercisers. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. From these values we provided a percentage of the number of people exercising optimally in the RAPA Cardiovascular.

Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3). Based on total scores we provided a percentage of people at optimum strength and flexibility.

Outcome measures

Measure	Fatigue: Take Control n=100 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=104 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Rapid Assessment of Physical Activity (RAPA) RAPA Cardiovascular	40 Participants	33 Participants
Rapid Assessment of Physical Activity (RAPA) RAPA Strength	51 Participants	53 Participants
Rapid Assessment of Physical Activity (RAPA) RAPA Flexibility	69 Participants	64 Participants

SECONDARY outcome

Timeframe: 4 months

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score between 0-21. Higher scores indicate worse sleep quality.

Outcome measures

Measure	Fatigue: Take Control n=100 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=104 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Pittsburgh Sleep Quality Index (PSQI)	7.41 units on a scale Standard Deviation 4.27	7.71 units on a scale Standard Deviation 3.85

SECONDARY outcome

Timeframe: 4 months

The time to walk 8 meters or 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r = 0.91), without the variability that the ordinal scale reflects.T25-FW was used in this study to measure ambulation status and as an additional measure of mobility. The score for the T25-FWis the average of the two completed trials in seconds

Outcome measures

Measure	Fatigue: Take Control n=100 Participants Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=104 Participants MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Timed 25 Foot Walk (T25-FW)	8.17 seconds Standard Deviation 7.78	10.55 seconds Standard Deviation 11.94

Adverse Events

Fatigue: Take Control

Serious events: 12 serious events

Other events: 86 other events

Deaths: 0 deaths

MS: Take Control

Serious events: 10 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fatigue: Take Control n=109 participants at risk Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=109 participants at risk MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Nervous system disorders MS related	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Surgical and medical procedures Surgery	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Fracture from a fall	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Social circumstances Hospitalization for mental health	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Gastrointestinal disorders Constipation requiring hospitalization	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Cardiac disorders Defibrulator change resulting in hospitalization	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Immune system disorders Bee sting reaction	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Renal and urinary disorders Hernia	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Social circumstances Social circumstances	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Syncopal event	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders Difficulty breathing	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Seizure	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS Hug	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Cardiac disorders Chest pain	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS exacerbation	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.

Other adverse events

Measure	Fatigue: Take Control n=109 participants at risk Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline	MS: Take Control n=109 participants at risk MS: Take Control includes topics of interest to people with MS other than fatigue. MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue.
Musculoskeletal and connective tissue disorders fall	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Increased pain following car accident	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Cardiac disorders Chest pain. Undetermined orgin.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Cardiac disorders Shortness of breath and chest pains.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Gastrointestinal disorders nausea-diarrhea	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Gastrointestinal disorders Nausea	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Gastrointestinal disorders gastrointestinal pain	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Gastrointestinal disorders abdominal pain due to gastroparesis	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Gastrointestinal disorders bowel discomfort	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders hot flashes	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders hot flashes, fatigue and tremors	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders vertigo	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders Dizziness/balance	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders sedation/fainting from side effects of bladder medication	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders headache/migraine	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders Root canal	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders Increase in headaches, vertigo, weakness and fatigue	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders Headaches	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders headache	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
General disorders worsening headaches	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Infections and infestations sinus infection	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Infections and infestations flu	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Infections and infestations Infection	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders right hand pain	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Broken tooth	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Worsening focus and attention problems	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Increased pain left side of body	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders fall due to lightheadness	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders pain/stiffness/locking in left hip (from torn ligament)	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders left knee pain	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders right leg weakness	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders increased spasticity	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders swollen foot	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders left arm pain	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders right thigh soreness on ambulation	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders weakenss in right thigh	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Worsening of left knee. Hyperextension and weakness.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders strained groin muscle	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders increased shakiness in right arm	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders right hip increased ache, stiffness	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Right arm tendonitis	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders left shoulder/arm pain into mid back with back spasms	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Fever, body aches	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Increase in pain	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders heel spur	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS related	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	100.0% 1/1 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders migraine	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders cluster headaches	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders worsening insomnia	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS flareup; 5 days of sterioids (outpatient visits)	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Insomnia, dizziness, fatigue	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders tremors and increased fatigue	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders changes in peripheral vision	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders chest pain related to MS flare-up	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders fatigue	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS exacerbation: leg weakness	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS exacerbation: suspected optic neurtits (blurred vision)	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders MS exacerbation:spine curvature, stiffness, spasticity	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders facial numbness	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Increased leg weakness & declining mobility	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders increased facial pain right side below right eye	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders increased fatigue, spasticity, and tingling.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Increased fatigue	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Left heel drop	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Mental disorientation	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders epidural steroid injections for pain	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders muscle spasms, neck	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Diagnosis of external snapping hip syndrome	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Loss of feeling in vulvar glands	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders Muscle pain	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Nervous system disorders excessive fatigue: physical and cognitive change	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Renal and urinary disorders UTI	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Renal and urinary disorders Recurrent right inguinal hernia	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Renal and urinary disorders Angioedema for side effects of bladder medication	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Renal and urinary disorders hernia; seen by primary care MD	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Renal and urinary disorders bladder issues exacerbated by levoquin antibiotic for bronchitis	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Reproductive system and breast disorders Brusing of uterus, and fallopian tubes	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Reproductive system and breast disorders Hemorragic ovarian cysts	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Reproductive system and breast disorders vaginal dryness	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders Breathing/sinus difficutlies from deviated septum surgery	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders bronchitis	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders sinitus	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders Greater difficulty breathing. Cardiac tests negative. Referred to a pulmonologist.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders persistant cough	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Respiratory, thoracic and mediastinal disorders Upper respiratory/cold	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Skin and subcutaneous tissue disorders Piece of metal in foot	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Skin and subcutaneous tissue disorders skin rash	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Skin and subcutaneous tissue disorders Pruritis skin condition	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Skin and subcutaneous tissue disorders prutiis skin condition	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Skin and subcutaneous tissue disorders skin lesions possible due to injection reaction	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Skin and subcutaneous tissue disorders Skin problems	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Social circumstances increase in anxiety	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.
Social circumstances Emotional	0.00% 0/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.	0.92% 1/109 Subjects were asked to self report all health problems that occurred during the study at each study visit regardless of relation to study. The study PI then reviewed what subjects had written and categorized each adverse event based on written information from the participant according to organ system class.

Additional Information

Cinda Hugos

Portland VA Medical Center

Phone: 503-220-8262

Email: hugosc@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place