Trial Outcomes & Findings for DVD Lifestyle Intervention (NCT NCT03260140)
NCT ID: NCT03260140
Last Updated: 2023-07-28
Results Overview
Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
511 participants
Primary outcome timeframe
Weight closest to 12 months from baseline between 9-15 months post-baseline
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
Behavioral Lifestyle Intervention
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
participant in this arm will continue with usual care
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
257
|
|
Overall Study
COMPLETED
|
249
|
252
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Behavioral Lifestyle Intervention
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
participant in this arm will continue with usual care
|
|---|---|---|
|
Overall Study
Death
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
DVD Lifestyle Intervention
Baseline characteristics by cohort
| Measure |
Behavioral Lifestyle Intervention
n=254 Participants
The investigators will provide participants with the the behavioral lifestyle intervention
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=257 Participants
participant in this arm will continue with usual care
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 14.17 • n=99 Participants
|
58.1 years
STANDARD_DEVIATION 13.58 • n=107 Participants
|
57.4 years
STANDARD_DEVIATION 13.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
217 Participants
n=99 Participants
|
223 Participants
n=107 Participants
|
440 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
409 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weight closest to 12 months from baseline between 9-15 months post-baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
Weights were obtained from the VA electronic health record. For the weight variable, baseline is the weight used to identify Veterans for recruitment to participate.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=217 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=212 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Body Weight
|
99.8 kilogram (kg)
Standard Deviation 15.8
|
101.0 kilogram (kg)
Standard Deviation 15.0
|
PRIMARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the PCS score serving as co-primary outcome. The investigators scored the SF-12 using QualityMetric's scoring software. PCS scores range from 0-100 with higher scores indicating better general physical health.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=191 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=219 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Short Form (SF)-12 PCS
|
44.3 score on a scale
Standard Deviation 10.7
|
43.2 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted number of participants engaging in at least 150 minutes of activity per week. The analysis population for adjusted between-group differences includes study participants with measurements at both baseline and 12 months; see Statistical Analysis 1 for those results.
7-item short form of the IPAQ, which evaluates weekly walking, vigorous and moderate-intensity activity. The investigators report here the number of participants engaging in at least 150 minutes of activity per week.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=193 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=219 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ)
|
149 Participants
|
143 Participants
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
8-item self-report measure of diet quality that assesses intake of various types of food (e.g., fruit and vegetable, sugary beverages). Scores range from 0-16 with higher scores indicating better diet quality.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=191 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=217 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
"Starting the Conversation"
|
6.2 score on a scale
Standard Deviation 2.6
|
6.4 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results
4-item self-report scale indicating sleep disturbance. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep disturbance.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=192 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=219 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey Change
|
52.5 T-score
Standard Deviation 9.2
|
52.0 T-score
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
8-item self-report scale indicating sleep impairment. Raw scores are converted into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher scores represent more sleep impairment.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=193 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=218 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Survey Change
|
51.7 T-score
Standard Deviation 10.7
|
52.2 T-score
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
Three items measuring diet self-efficacy from the Patient-centered Assessment and Counseling for Exercise plus Nutrition (PACE+) Adult Psychosocial Questionnaire. Scores range from 1-5 with higher scores representing higher diet self-efficacy.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=193 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=219 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Dietary Self-efficacy
|
3.1 score on a scale
Standard Deviation 1.0
|
3.0 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: HbA1c closest to 12 months from baseline between 9-15 months post-baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
HbA1c values were obtained from the VA electronic health record. HbA1c is a measure of the percentage of glucose in the blood.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=135 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=133 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Hemoglobin A1c (HbA1c)
|
6.3 percentage of glycosylated hemoglobin
Standard Deviation 1.5
|
6.4 percentage of glycosylated hemoglobin
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
The SF-12 is a health-related quality of life measure that assesses general physical (PCS) and mental health (MCS) functioning and well-being, with the MCS score assessing mental health status. The investigators scored the SF-12 using QualityMetric's scoring software. MCS scores range from 0-100 with higher scores indicating better general menal health.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=191 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=219 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Short Form (SF)-12 Mental Component Score (MCS)
|
47.2 score on a scale
Standard Deviation 12.4
|
48.1 score on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: DBP closest to 12 months from baseline between 9-15 months post-baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
DBP values were obtained from the VA electronic health record. DBP is a measure of artery pressure when the heart rests between beats.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=205 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=194 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Diastolic Blood Pressure (DBP)
|
77.4 millimeters of mercury (mmHg)
Standard Deviation 8.0
|
77.2 millimeters of mercury (mmHg)
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: SBP closest to 12 months from baseline between 9-15 months post-baselinePopulation: The investigators report here the unadjusted means at 12 months. The analysis population for adjusted between-group differences includes study participants with a measurement at baseline and/or 12-month follow-up; see Statistical Analysis 1 for those results.
SBP values were obtained from the VA electronic health record. SBP is a measure of how much pressure blood is exerting against artery walls when the heart beats.
Outcome measures
| Measure |
Behavioral Lifestyle Intervention
n=205 Participants
behavioral lifestyle intervention: the investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=194 Participants
participant in this arm will continue with usual care
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
|
127.3 millimeters of mercury (mmHg)
Standard Deviation 11.6
|
126.9 millimeters of mercury (mmHg)
Standard Deviation 13.3
|
Adverse Events
Behavioral Lifestyle Intervention
Serious events: 47 serious events
Other events: 124 other events
Deaths: 4 deaths
Usual Care Control
Serious events: 42 serious events
Other events: 105 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Behavioral Lifestyle Intervention
n=254 participants at risk
The investigators will provide participants with the the behavioral lifestyle intervention
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=257 participants at risk
participant in this arm will continue with usual care
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
4.7%
12/254 • Number of events 16 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
7.0%
18/257 • Number of events 18 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
1.2%
3/254 • Number of events 3 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.6%
4/257 • Number of events 4 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.9%
10/254 • Number of events 11 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.9%
5/257 • Number of events 5 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Blood and lymphatic system disorders
Hematological
|
1.2%
3/254 • Number of events 3 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.2%
3/257 • Number of events 3 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Metabolism and nutrition disorders
Metabolic
|
1.2%
3/254 • Number of events 3 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
0.78%
2/257 • Number of events 2 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.9%
10/254 • Number of events 10 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.6%
4/257 • Number of events 4 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Nervous system disorders
Neurological
|
1.6%
4/254 • Number of events 5 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.6%
4/257 • Number of events 4 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Psychiatric disorders
Psychological
|
1.2%
3/254 • Number of events 3 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
0.78%
2/257 • Number of events 2 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory
|
3.5%
9/254 • Number of events 9 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.9%
5/257 • Number of events 7 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Renal and urinary disorders
Renal/Urologic
|
2.0%
5/254 • Number of events 5 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.2%
3/257 • Number of events 3 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.79%
2/254 • Number of events 2 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
0.39%
1/257 • Number of events 1 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
General disorders
Other
|
4.3%
11/254 • Number of events 11 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
3.1%
8/257 • Number of events 8 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
Other adverse events
| Measure |
Behavioral Lifestyle Intervention
n=254 participants at risk
The investigators will provide participants with the the behavioral lifestyle intervention
behavioral lifestyle intervention: The investigators will provide participants with the behavioral lifestyle intervention
|
Usual Care Control
n=257 participants at risk
participant in this arm will continue with usual care
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
2.8%
7/254 • Number of events 7 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
5.4%
14/257 • Number of events 15 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
7.5%
19/254 • Number of events 25 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
4.7%
12/257 • Number of events 13 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Gastrointestinal disorders
Gastrointestinal
|
8.3%
21/254 • Number of events 22 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
6.2%
16/257 • Number of events 16 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Blood and lymphatic system disorders
Hematological
|
0.79%
2/254 • Number of events 2 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
0.00%
0/257 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Metabolism and nutrition disorders
Metabolic
|
0.39%
1/254 • Number of events 1 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
1.9%
5/257 • Number of events 5 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
25.6%
65/254 • Number of events 79 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
14.8%
38/257 • Number of events 44 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Nervous system disorders
Neurological
|
7.1%
18/254 • Number of events 20 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
4.3%
11/257 • Number of events 11 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Psychiatric disorders
Psychological
|
2.0%
5/254 • Number of events 5 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
2.3%
6/257 • Number of events 6 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory
|
6.7%
17/254 • Number of events 19 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
6.2%
16/257 • Number of events 18 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Renal and urinary disorders
Renal/Urologic
|
4.3%
11/254 • Number of events 12 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
3.5%
9/257 • Number of events 11 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
Hepatobiliary disorders
Hepatobiliary
|
0.39%
1/254 • Number of events 1 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
0.39%
1/257 • Number of events 1 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
|
General disorders
Other
|
11.4%
29/254 • Number of events 33 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
8.6%
22/257 • Number of events 23 • We systematically collected adverse events (AE) by body system as part of the the 12- and 24-month follow-up survey process. For conditions that participants indicated were new since their baseline visit, study staff conducted electronic health record chart review for details of that condition.
Adverse Events were monitored/assessed without regard to specific Adverse Event Terms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place