Trial Outcomes & Findings for Self-Management of Osteoarthritis (NCT NCT00288912)

Last Updated: 2015-04-24

Results Overview

Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale ("all days" to "no days"). The possible range of scores is 0-10, with higher scores indicating more severe pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

523 participants

Primary outcome timeframe

Baseline and 12-month follow-up

Results posted on

2015-04-24

Participant Flow

Recruitment began on Oct 3, 2006 and ended on June 30, 2008. We used VA medical records to identify patients with hip and knee OA and no exclusionary diagnoses. We mailed introductory letters to these individuals and followed up with a screening phone call. Eligible patients were asked to come to the Durham VA for a baseline visit.

Participant milestones

Participant milestones
Measure	Arm 1 Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 Usual Medical Care	Arm 3 Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
Overall Study STARTED	175	174	174
Overall Study COMPLETED	158	157	146
Overall Study NOT COMPLETED	17	17	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 Usual Medical Care	Arm 3 Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
Overall Study Developed exclusion criterion	4	6	7
Overall Study Lost to Follow-up	9	6	9
Overall Study Withdrawal by Subject	4	5	12

Baseline Characteristics

Self-Management of Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=172 Participants Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=171 Participants Usual Medical Care	Arm 3 n=172 Participants Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.	Total n=515 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.1 • n=7 Participants	60.3 years STANDARD_DEVIATION 10.3 • n=5 Participants	60.1 years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	160 Participants n=5 Participants	161 Participants n=7 Participants	157 Participants n=5 Participants	478 Participants n=4 Participants
Race/Ethnicity, Customized White	91 participants n=5 Participants	92 participants n=7 Participants	95 participants n=5 Participants	278 participants n=4 Participants
Race/Ethnicity, Customized Non-White	81 participants n=5 Participants	79 participants n=7 Participants	77 participants n=5 Participants	237 participants n=4 Participants
Region of Enrollment United States	172 participants n=5 Participants	171 participants n=7 Participants	172 participants n=5 Participants	515 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 12-month follow-up

Outcome measures

Outcome measures
Measure	Arm 1 n=172 Participants Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=171 Participants Usual Medical Care	Arm 3 n=172 Participants Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
Pain Baseline	6.01 units on a scale Standard Deviation 2.28	5.77 units on a scale Standard Deviation 2.14	5.92 units on a scale Standard Deviation 2.27
Pain 12-Month Follow-Up	5.84 units on a scale Standard Deviation 2.32	5.46 units on a scale Standard Deviation 2.03	5.22 units on a scale Standard Deviation 2.44

SECONDARY outcome

Timeframe: Baseline and 12-month follow-up

The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale ("all days" to "no days"). Scores can range from 0-10, with higher scores indicating worse function.

Outcome measures

Outcome measures
Measure	Arm 1 n=172 Participants Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=171 Participants Usual Medical Care	Arm 3 n=172 Participants Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
AIMS 2 Physical Function 12-Month Follow-Up	2.87 units on a scale Standard Deviation 1.94	2.34 units on a scale Standard Deviation 1.55	2.57 units on a scale Standard Deviation 1.77
AIMS 2 Physical Function Baseline	2.70 units on a scale Standard Deviation 1.78	2.27 units on a scale Standard Deviation 1.34	2.60 units on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: Baseline and 12 months

The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale ("all days" to "no days"). Scores can range from 0-10, with higher scores indicating worse affect.

Outcome measures

Outcome measures
Measure	Arm 1 n=172 Participants Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=171 Participants Usual Medical Care	Arm 3 n=172 Participants Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
AIMS 2 Affect Baseline	3.64 units on a scale Standard Deviation 2.26	3.23 units on a scale Standard Deviation 2.04	3.74 units on a scale Standard Deviation 2.29
AIMS 2 Affect 12-Month Follow-Up	3.44 units on a scale Standard Deviation 2.20	3.08 units on a scale Standard Deviation 2.09	3.58 units on a scale Standard Deviation 3.35

SECONDARY outcome

Timeframe: Baseline and 12 months

The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.

Outcome measures

Outcome measures
Measure	Arm 1 n=172 Participants Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=171 Participants Usual Medical Care	Arm 3 n=172 Participants Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
Arthritis Self Efficacy Baseline	5.78 units on a scale Standard Deviation 2.01	5.92 units on a scale Standard Deviation 1.92	5.68 units on a scale Standard Deviation 2.07
Arthritis Self Efficacy 12-Month Follow-Up	5.80 units on a scale Standard Deviation 2.06	5.96 units on a scale Standard Deviation 1.96	6.09 units on a scale Standard Deviation 2.13

Adverse Events

Arm 1

Serious events: 10 serious events

Other events: 33 other events

Deaths: 0 deaths

Arm 2

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Arm 3

Serious events: 14 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=175 participants at risk Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=174 participants at risk Usual Medical Care	Arm 3 n=174 participants at risk Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
General disorders Death	0.00% 0/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Cardiac disorders Hospital Admission	1.1% 2/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	1.7% 3/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	4.0% 7/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospital Admission	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Infections and infestations Hospital Admission	0.00% 0/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
General disorders Hospital Admission	0.00% 0/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Surgical and medical procedures Inpatient Surgery	2.3% 4/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	3.4% 6/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	4.0% 7/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Significant Disability	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Renal and urinary disorders Hospital Admission	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Respiratory, thoracic and mediastinal disorders Hospital Admission	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Musculoskeletal and connective tissue disorders Hospital Admission	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Endocrine disorders Hospital Admission	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Nervous system disorders Significant Disability	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Hepatobiliary disorders Hospital Admission	0.00% 0/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.

Other adverse events

Other adverse events
Measure	Arm 1 n=175 participants at risk Health Education Intervention Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.	Arm 2 n=174 participants at risk Usual Medical Care	Arm 3 n=174 participants at risk Osteoarthritis Self-Management Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
Gastrointestinal disorders Emergency Room Visit	1.1% 2/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	3.4% 6/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Musculoskeletal and connective tissue disorders Emergency Room Visit	11.4% 20/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	4.0% 7/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	10.9% 19/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Respiratory, thoracic and mediastinal disorders Emergency Room Visit	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	2.9% 5/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	4.0% 7/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
General disorders Emergency Room Visit	6.3% 11/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	6.3% 11/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	7.5% 13/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Cardiac disorders Emergency Room Visit	0.00% 0/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	1.1% 2/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Ear and labyrinth disorders Emergency Room Visit	0.00% 0/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Renal and urinary disorders Emergency Room Visit	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Surgical and medical procedures Outpatient Surgery	5.7% 10/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	5.7% 10/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	8.0% 14/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Psychiatric disorders Emergency Room Visit	1.1% 2/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Vascular disorders Emergency Room Visit	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Eye disorders Emergency Room Visit	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Skin and subcutaneous tissue disorders Emergency Room Visit	1.1% 2/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.57% 1/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
Infections and infestations Emergency Room Visit	0.57% 1/175 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.	0.00% 0/174 We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.

Additional Information

Dr. Kelli Allen

Durham VA HSR&D

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place