Trial Outcomes & Findings for Care Management for the Effective Use of Opioids (NCT NCT01236521)

NCT ID: NCT01236521

Last Updated: 2023-07-27

Results Overview

The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 261 participants
• Primary outcome timeframe: Baseline and 3, 6, 9, and 12 months
• Results posted on: 2023-07-27

Participant Flow

Participant milestones

Measure	Arm 1: Pharmacological (PHARM) Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants had an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment was assessed. Analgesic and co-analgesic therapy: During the baseline assessment, the nurse care managers determined current and past treatments for chronic lower back pain.	Arm 2: Behavioral Treatment (BEH) Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Study STARTED	131	130
Overall Study 3-month Completed	122	118
Overall Study 6-month Completed	121	114
Overall Study 9-month Completed	105	98
Overall Study 12-moth Completed	108	105
Overall Study COMPLETED	108	105
Overall Study NOT COMPLETED	23	25

Reasons for withdrawal

Measure	Arm 1: Pharmacological (PHARM) Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period. Participants had an initial visit at baseline to assess their current and past treatments for chronic lower back pain, pain intensity, and pain-related limitations. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment was assessed. Analgesic and co-analgesic therapy: During the baseline assessment, the nurse care managers determined current and past treatments for chronic lower back pain.	Arm 2: Behavioral Treatment (BEH) Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Overall Study Withdrawal by Subject	12	17
Overall Study Death	2	1
Overall Study Lost to Follow-up	9	7

Baseline Characteristics

Care Management for the Effective Use of Opioids

Baseline characteristics by cohort

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm will receive at least 8 contacts with the nurse care managers (NCM) over the trial period. During follow-up calls, patients' pain severity, response to treatment, adherence, adverse effects, and desire to change current treatment will be assessed. During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) will receive a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.	Total n=261 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	58.2 years STANDARD_DEVIATION 9.2 • n=7 Participants	57.9 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	117 Participants n=7 Participants	241 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	100 Participants n=7 Participants	191 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3, 6, 9, and 12 months

Population: We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.

The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months Baseline	6.45 units on a scale Standard Deviation 1.79	6.49 units on a scale Standard Deviation 1.67
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months 3 months	5.41 units on a scale Standard Deviation 2.10	5.86 units on a scale Standard Deviation 1.91
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months 6 months	5.39 units on a scale Standard Deviation 2.21	5.85 units on a scale Standard Deviation 1.84
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months 9 months	5.29 units on a scale Standard Deviation 2.25	5.66 units on a scale Standard Deviation 1.91
Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months 12 months	5.31 units on a scale Standard Deviation 2.27	5.85 units on a scale Standard Deviation 1.98

PRIMARY outcome

Timeframe: Baseline and 3, 6, 9, and 12 months

Population: We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.

The Brief Pain Inventory pain intensity score is scored from 0 (no pain) to 10 (worst pain imaginable). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point Baseline	6.78 units on a scale Standard Deviation 1.65	6.76 units on a scale Standard Deviation 1.47
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point 3 months	5.96 units on a scale Standard Deviation 1.86	6.24 units on a scale Standard Deviation 1.56
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point 6 months	5.94 units on a scale Standard Deviation 1.95	6.45 units on a scale Standard Deviation 1.60
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point 9 months	5.84 units on a scale Standard Deviation 1.83	6.18 units on a scale Standard Deviation 1.69
Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point 12 months	5.76 units on a scale Standard Deviation 2.14	6.36 units on a scale Standard Deviation 1.59

PRIMARY outcome

Timeframe: Baseline and 3, 6, 9, and 12 months

Population: We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.

The Brief Pain Inventory Pain Interference Scale score assesses if pain interferes with 7 common activities. This scale is score 0 (no interference) to 10 (high interference). The 7-items are averaged to give a score.

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Brief Pain Inventory Pain Interference Scale Score Baseline	6.34 scores on a scale Standard Deviation 2.07	6.39 scores on a scale Standard Deviation 1.99
Brief Pain Inventory Pain Interference Scale Score 3 months	5.19 scores on a scale Standard Deviation 2.38	5.71 scores on a scale Standard Deviation 2.28
Brief Pain Inventory Pain Interference Scale Score 6 months	5.17 scores on a scale Standard Deviation 2.51	5.61 scores on a scale Standard Deviation 2.15
Brief Pain Inventory Pain Interference Scale Score 12 months	5.15 scores on a scale Standard Deviation 2.46	5.68 scores on a scale Standard Deviation 2.30
Brief Pain Inventory Pain Interference Scale Score 9 months	5.08 scores on a scale Standard Deviation 2.57	5.47 scores on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

The Pain Catastrophizing Scale a 13-item scale that assesses catastrophizing - a pain belief that have been found to be strong predictor of poor treatment response. It is scored from 0 (no catastrophizing) to 52 (severe catastrophizing)

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Pain Catastrophizing Scale Baseline	23.95 scores on a scale Standard Deviation 12.77	24.44 scores on a scale Standard Deviation 11.27
Pain Catastrophizing Scale 6 months	21.64 scores on a scale Standard Deviation 13.20	20.41 scores on a scale Standard Deviation 12.54
Pain Catastrophizing Scale 12 months	22.14 scores on a scale Standard Deviation 13.84	20.43 scores on a scale Standard Deviation 12.04

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

The Roland Morris Disability Scale is a 24-item pain-specific measure of physical disability. It provides a score from 0 (no disability) to 24 (high disability)

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Roland Morris Disability Scale Baseline	16.59 scores on a scale Standard Deviation 4.70	16.72 scores on a scale Standard Deviation 4.15
Roland Morris Disability Scale 3 months	15.55 scores on a scale Standard Deviation 5.18	15.80 scores on a scale Standard Deviation 5.20
Roland Morris Disability Scale 6 months	15.32 scores on a scale Standard Deviation 5.20	15.34 scores on a scale Standard Deviation 5.50
Roland Morris Disability Scale 9 months	15.54 scores on a scale Standard Deviation 5.53	15.33 scores on a scale Standard Deviation 5.50
Roland Morris Disability Scale 12 months	15.60 scores on a scale Standard Deviation 5.85	16.58 scores on a scale Standard Deviation 5.34

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

The Patient Health Questionnaire-9 is used to assess depression severity. It's 9-items that are scored from 0 (no depression) to 27 (severe depression)

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Patient Health Questionnaire-9 Baseline	11.18 scores on a scale Standard Deviation 6.40	11.19 scores on a scale Standard Deviation 5.82
Patient Health Questionnaire-9 3 months	9.74 scores on a scale Standard Deviation 6.33	9.94 scores on a scale Standard Deviation 6.14
Patient Health Questionnaire-9 6 months	9.74 scores on a scale Standard Deviation 6.56	10.04 scores on a scale Standard Deviation 6.12
Patient Health Questionnaire-9 9 months	9.67 scores on a scale Standard Deviation 6.41	9.84 scores on a scale Standard Deviation 5.68
Patient Health Questionnaire-9 12 months	10.13 scores on a scale Standard Deviation 6.95	10.53 scores on a scale Standard Deviation 6.21

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 9 months, and 12 months

The GAD-7 is a measure of anxiety. The GAD-7 consists of 7 items that are scored from 0 (no anxiety) to 21 (severe anxiety)

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Generalized Anxiety Disorder 7-item (GAD-7) Scale Baseline	6.68 scores on a scale Standard Deviation 5.13	6.81 scores on a scale Standard Deviation 4.63
Generalized Anxiety Disorder 7-item (GAD-7) Scale 3 months	6.65 scores on a scale Standard Deviation 4.50	6.08 scores on a scale Standard Deviation 4.57
Generalized Anxiety Disorder 7-item (GAD-7) Scale 6 months	6.00 scores on a scale Standard Deviation 5.23	6.22 scores on a scale Standard Deviation 4.88
Generalized Anxiety Disorder 7-item (GAD-7) Scale 9 months	6.30 scores on a scale Standard Deviation 4.92	5.92 scores on a scale Standard Deviation 4.83
Generalized Anxiety Disorder 7-item (GAD-7) Scale 12 months	6.41 scores on a scale Standard Deviation 5.30	7.02 scores on a scale Standard Deviation 4.98

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

The AUDIT-C is validated as an effective screening test and diagnostic tool for alcohol misuse in primary care samples. It is scored on 0 to 10 score with higher scores representing alcohol misuse

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
AUDIT-C Baseline	5.65 scores on a scale Standard Deviation 5.51	5.87 scores on a scale Standard Deviation 5.71
AUDIT-C 6 months	5.42 scores on a scale Standard Deviation 5.69	5.75 scores on a scale Standard Deviation 5.40
AUDIT-C 12 months	5.06 scores on a scale Standard Deviation 5.58	5.36 scores on a scale Standard Deviation 5.66

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

The COMM (Current Opioid Misuse Measure) is a 17-item instrument designed to monitor misuse and aberrant behaviors in patients prescribed opioids. The scale is scored from 0 (no evidence of opioid misuse or aberrant behaviors) to 64 (strong evidence for opioid misuse and aberrant behaviors)

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
Current Opioid Misuse Measure (COMM) Baseline	8.73 scores on a scale Standard Deviation 6.81	8.87 scores on a scale Standard Deviation 6.54
Current Opioid Misuse Measure (COMM) 6 months	7.29 scores on a scale Standard Deviation 6.96	8.20 scores on a scale Standard Deviation 6.85
Current Opioid Misuse Measure (COMM) 12 months	7.60 scores on a scale Standard Deviation 6.96	8.96 scores on a scale Standard Deviation 7.94

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

The SF-36 is a subscale that assesses the self-reported general health. It is scored on a 0 to 100 scale with higher scores representing greater perceived general health

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
SF-36 General Health Perception Baseline	43.66 scores on a scale Standard Deviation 20.92	45.39 scores on a scale Standard Deviation 18.64
SF-36 General Health Perception 6 months	45.85 scores on a scale Standard Deviation 19.89	45.83 scores on a scale Standard Deviation 20.40
SF-36 General Health Perception 12 months	42.70 scores on a scale Standard Deviation 23.03	42.44 scores on a scale Standard Deviation 20.17

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

The SF-36 vital score is a subscale that assesses participants' vitality/energy. It is scored on a 0 to 100 scale with higher scores representing greater vitality/energy.

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
SF-36 Vitality Scale Baseline	38.64 scores on a scale Standard Deviation 16.98	35.08 scores on a scale Standard Deviation 16.17
SF-36 Vitality Scale 6 months	40.00 scores on a scale Standard Deviation 17.50	38.33 scores on a scale Standard Deviation 17.06
SF-36 Vitality Scale 12 months	40.51 scores on a scale Standard Deviation 16.28	38.19 scores on a scale Standard Deviation 15.74

SECONDARY outcome

Timeframe: Baseline, 6 months, and 12 months

The SF-36 social functioning scale is a subscale that assesses the self-reported social functioning. It is scored on a 0 to 100 scale with higher scores representing better social functioning.

Outcome measures

Measure	Arm 1: Pharmacological (PHARM) n=131 Participants Subjects in the Pharmacological (PHARM) arm received at least 8 contacts with the nurse care managers (NCM) over the trial period.	Arm 2: Behavioral Treatment (BEH) n=130 Participants Veterans randomized to behavioral treatment arm (BEH) received a series of 8 pain self-management/coping skills training sessions delivered by one of three primary-care based clinical psychologists.
SF-36 Social Functioning Scale Baseline	48.47 scores on a scale Standard Deviation 27.21	49.81 scores on a scale Standard Deviation 29.32
SF-36 Social Functioning Scale 6 months	55.79 scores on a scale Standard Deviation 29.67	51.10 scores on a scale Standard Deviation 27.40
SF-36 Social Functioning Scale 12 months	55.72 scores on a scale Standard Deviation 28.49	52.02 scores on a scale Standard Deviation 28.12

Adverse Events

Arm 1: Pharmacological (PHARM)

Serious events: 6 serious events

Other events: 10 other events

Deaths: 2 deaths

Arm 2: Behavioral Treatment (BEH)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Arm 1: Pharmacological (PHARM) n=131 participants at risk Nurse care managers followed an analgesic algorithm; supervised by study physicians	Arm 2: Behavioral Treatment (BEH) n=130 participants at risk Clinical psychologist delivered pain self-management/pain coping skills to Veterans
Surgical and medical procedures Knee Replacement Surgery	0.76% 1/131 • Number of events 1 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.77% 1/130 • Number of events 1 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Gastrointestinal disorders Small Bowel Obstruction	1.5% 2/131 • Number of events 6 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Infections and infestations Urinary Tract Infection and Sepsis	1.5% 2/131 • Number of events 2 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Cardiac disorders Atrial Fibrillation	0.76% 1/131 • Number of events 1 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Other adverse events

Measure	Arm 1: Pharmacological (PHARM) n=131 participants at risk Nurse care managers followed an analgesic algorithm; supervised by study physicians	Arm 2: Behavioral Treatment (BEH) n=130 participants at risk Clinical psychologist delivered pain self-management/pain coping skills to Veterans
Infections and infestations other adverse event	4.6% 6/131 • Number of events 6 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Musculoskeletal and connective tissue disorders other adverse event	0.00% 0/131 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	1.5% 2/130 • Number of events 2 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Cardiac disorders other adverse event	0.76% 1/131 • Number of events 2 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Gastrointestinal disorders other adverse event	1.5% 2/131 • Number of events 4 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Renal and urinary disorders other adverse event	0.76% 1/131 • Number of events 1 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/130 Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Additional Information

Dr. Matthew J. Bair

VA Center for Health Information and Communication

Phone: 317-988-2058

Email: mbair@iupui.edu; Matthew.Bair@va.gov

Results disclosure agreements

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