Trial Outcomes & Findings for Using Digital Health, Financial Incentives, and Community Health Worker Support to Change Health Behavior (NCT NCT03939793)

Last Updated: 2024-09-05

Results Overview

constructed by summing the number of days in the study period that the glucometer was used divided by the total number of days in study period

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

3 months

Results posted on

2024-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care.	Digital Health Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card. If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider.	Hybrid Digital Health and Community Health Worker Support Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support. CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended.
Overall Study STARTED	50	50	50
Overall Study COMPLETED	40	34	28
Overall Study NOT COMPLETED	10	16	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant declined to answer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=50 Participants Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care.	Digital Health n=50 Participants Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card. If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider.	Hybrid Digital Health and Community Health Worker Support n=50 Participants Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support. CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended.	Total n=150 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 8.7 • n=50 Participants	55.0 years STANDARD_DEVIATION 14.1 • n=50 Participants	54.1 years STANDARD_DEVIATION 12.8 • n=50 Participants	55.1 years STANDARD_DEVIATION 12.0 • n=150 Participants
Sex: Female, Male Female	34 Participants n=49 Participants • Participant declined to answer	36 Participants n=50 Participants • Participant declined to answer	35 Participants n=50 Participants • Participant declined to answer	105 Participants n=149 Participants • Participant declined to answer
Sex: Female, Male Male	15 Participants n=49 Participants • Participant declined to answer	14 Participants n=50 Participants • Participant declined to answer	15 Participants n=50 Participants • Participant declined to answer	44 Participants n=149 Participants • Participant declined to answer
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=50 Participants	3 Participants n=50 Participants	3 Participants n=50 Participants	8 Participants n=150 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=50 Participants	46 Participants n=50 Participants	47 Participants n=50 Participants	141 Participants n=150 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=150 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants	1 Participants n=50 Participants	4 Participants n=50 Participants	5 Participants n=150 Participants
Race (NIH/OMB) Asian	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=150 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=150 Participants
Race (NIH/OMB) Black or African American	45 Participants n=50 Participants	39 Participants n=50 Participants	42 Participants n=50 Participants	126 Participants n=150 Participants
Race (NIH/OMB) White	1 Participants n=50 Participants	0 Participants n=50 Participants	3 Participants n=50 Participants	4 Participants n=150 Participants
Race (NIH/OMB) More than one race	2 Participants n=50 Participants	3 Participants n=50 Participants	0 Participants n=50 Participants	5 Participants n=150 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=50 Participants	6 Participants n=50 Participants	1 Participants n=50 Participants	9 Participants n=150 Participants
Highest level of education Less than HS	15 Participants n=50 Participants	10 Participants n=50 Participants	11 Participants n=50 Participants	36 Participants n=150 Participants
Highest level of education HS or GED	16 Participants n=50 Participants	22 Participants n=50 Participants	20 Participants n=50 Participants	58 Participants n=150 Participants
Highest level of education Some college/technical school	15 Participants n=50 Participants	13 Participants n=50 Participants	14 Participants n=50 Participants	42 Participants n=150 Participants
Highest level of education College graduate	4 Participants n=50 Participants	5 Participants n=50 Participants	5 Participants n=50 Participants	14 Participants n=150 Participants
Household income <15K	32 Participants n=50 Participants	30 Participants n=50 Participants	32 Participants n=50 Participants	94 Participants n=150 Participants
Household income >=15K	16 Participants n=50 Participants	18 Participants n=50 Participants	17 Participants n=50 Participants	51 Participants n=150 Participants
Household income Unknown	2 Participants n=50 Participants	2 Participants n=50 Participants	1 Participants n=50 Participants	5 Participants n=150 Participants
Employed	9 Participants n=50 Participants	7 Participants n=50 Participants	2 Participants n=50 Participants	18 Participants n=150 Participants
Insurance Medicaid	27 Participants n=50 Participants	27 Participants n=50 Participants	33 Participants n=50 Participants	87 Participants n=150 Participants
Insurance Medicaid/Medicare	23 Participants n=50 Participants	22 Participants n=50 Participants	16 Participants n=50 Participants	61 Participants n=150 Participants
Insurance Uninsured	0 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=150 Participants
Insurance Other	0 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=50 Participants	1 Participants n=150 Participants
Prior healthcare utilization, past 6 months (self-report) Any ED visit	23 Participants n=50 Participants	29 Participants n=50 Participants	30 Participants n=50 Participants	82 Participants n=150 Participants
Prior healthcare utilization, past 6 months (self-report) Any hospital admission	19 Participants n=50 Participants	20 Participants n=50 Participants	14 Participants n=50 Participants	53 Participants n=150 Participants
Postponed needed medical care	7 Participants n=50 Participants	9 Participants n=50 Participants	11 Participants n=50 Participants	27 Participants n=150 Participants
Health literacy	1.9 units on a scale STANDARD_DEVIATION 1.1 • n=50 Participants	1.8 units on a scale STANDARD_DEVIATION 1.2 • n=50 Participants	2.1 units on a scale STANDARD_DEVIATION 1.3 • n=50 Participants	1.9 units on a scale STANDARD_DEVIATION 1.2 • n=150 Participants
More than 1 competing need	14 Participants n=50 Participants	23 Participants n=50 Participants	20 Participants n=50 Participants	57 Participants n=150 Participants
Drug use	8 Participants n=50 Participants	6 Participants n=50 Participants	5 Participants n=50 Participants	19 Participants n=150 Participants
Alcohol overuse	11 Participants n=50 Participants	10 Participants n=50 Participants	7 Participants n=50 Participants	28 Participants n=150 Participants
Adverse childhood experiences	3.1 units on a scale STANDARD_DEVIATION 2.8 • n=50 Participants	3.3 units on a scale STANDARD_DEVIATION 2.6 • n=50 Participants	2.8 units on a scale STANDARD_DEVIATION 2.4 • n=50 Participants	3.0 units on a scale STANDARD_DEVIATION 2.6 • n=150 Participants
Perceived stress	5.9 units on a scale STANDARD_DEVIATION 3.5 • n=50 Participants	6.1 units on a scale STANDARD_DEVIATION 4.0 • n=50 Participants	5.7 units on a scale STANDARD_DEVIATION 3.6 • n=50 Participants	5.9 units on a scale STANDARD_DEVIATION 3.7 • n=150 Participants
Low social support	4 Participants n=50 Participants	7 Participants n=50 Participants	7 Participants n=50 Participants	18 Participants n=150 Participants
HbA1C	10.94 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.21 • n=50 Participants	11.05 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.58 • n=50 Participants	10.89 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.01 • n=50 Participants	10.96 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.94 • n=150 Participants
Patient Activation Measure	69.5 units on a scale STANDARD_DEVIATION 16.6 • n=50 Participants	67.3 units on a scale STANDARD_DEVIATION 15.4 • n=50 Participants	65.8 units on a scale STANDARD_DEVIATION 14.2 • n=50 Participants	67.6 units on a scale STANDARD_DEVIATION 15.4 • n=150 Participants

PRIMARY outcome

Timeframe: 3 months

constructed by summing the number of days in the study period that the glucometer was used divided by the total number of days in study period

Outcome measures

Outcome measures
Measure	Usual Care n=40 Participants Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care.	Digital Health n=34 Participants Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card. If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider.	Hybrid Digital Health and Community Health Worker Support n=28 Participants Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support. CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended.
Glucose Self-monitoring Adherence	65 percentage of days Standard Deviation 28	70 percentage of days Standard Deviation 25	72 percentage of days Standard Deviation 29

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.

Outcome measures

Outcome measures
Measure	Usual Care n=23 Participants Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care.	Digital Health n=21 Participants Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card. If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider.	Hybrid Digital Health and Community Health Worker Support n=24 Participants Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support. CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended.
Change in Glycosylated Hemoglobin	-0.49 percentage of glycosylated hemoglobin Standard Deviation 1.75	-0.85 percentage of glycosylated hemoglobin Standard Deviation 1.90	-0.74 percentage of glycosylated hemoglobin Standard Deviation 1.66

Adverse Events

Usual Care

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Digital Health

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Hybrid Digital Health and Community Health Worker Support

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Director of Evaluation

Penn Center for Community Health Workers

Phone: 267-624-5465

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Usual Care n=50 participants at risk Participants randomized to the usual-care arm were asked to check their daily blood glucose and to continue with their usual care.	Digital Health n=50 participants at risk Participants randomized to the digital health arm were asked to check their blood glucose and text the value daily to a phone number linked to the Way to Health platform. To promote early motivation and habit formation, participants were entered into a lottery each day they texted their glucose values for the first 6 weeks of the study period. Each day participants texted, the lottery provided an 18 in 100 chance of winning $5 and 1 in 100 chance of winning $50. Accrued money was distributed to participants biweekly on a reloadable card. If participants texted in a blood glucose value that was pre-established as medically dangerous (\< 60, \> 400), they received an automated text encouraging them to follow up with their provider. These values were also routed directly to the study clinician who called each patient within 24 hours to provide clinical management and coordinate care with the patient's provider.	Hybrid Digital Health and Community Health Worker Support n=50 participants at risk Participants in the hybrid arm received all aspects of the digital health intervention. Additionally, CHWs met with participants at enrollment and provided brief coaching using positive affect induction and attribution retraining to increase resilience to setbacks. At this meeting, CHWs explained to patients that they might work with them in the future if they needed additional support. During the first 12 weeks of the study, hybrid arm participants with low rates of SMBG (defined as 5 instances of missed readings) and/or elevated glucose readings (defined as a glucose level \> 300 mg/dL for \> 30% of days over any 2-week period) were 'escalated' to receive intensive CHW support. CHWs implemented the IMPaCT intervention, in which the CHW used an in-depth semi-structured interview guide to get to know participants' strengths, goals, and unmet social needs. Participants' individualized goals became the basis for tailored action plans. For the remainder of the 24-week study period, CHWs provided coaching, social support, advocacy, and navigation to support participants in achieving their health goals. CHWs communicated with participants at least once per week, including monthly face-to-face contact. CHWs normalized setbacks and used positive affect induction and attribution retraining to help patients to cope with failure. CHWs also helped participants connect to long-term family and social supports after the intervention ended.
Blood and lymphatic system disorders Anemia	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Cardiac disorders Myocardial Infarction	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Cardiac disorders Volume Overload	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Endocrine disorders Diabetic Ketoacidosis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Endocrine disorders Hyperglycemia	4.0% 2/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Endocrine disorders Hypoglycemia	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Gastrointestinal disorders Gastroenteritis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Gastrointestinal disorders Gastroparesis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Nervous system disorders Altered mental status	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
General disorders Chest pain	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Infections and infestations Finger infection	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Infections and infestations Sepsis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Infections and infestations COVID-19	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Infections and infestations Diabetic foot infection	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Injury, poisoning and procedural complications Post-operative pain	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Musculoskeletal and connective tissue disorders Ankle fracture	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Musculoskeletal and connective tissue disorders Osteomyelitis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	6.0% 3/50 • Adverse event data was collected for 6 months post-enrollment.
Nervous system disorders Seizure	4.0% 2/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Nervous system disorders Subarachnoid hemorrhage	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Pregnancy, puerperium and perinatal conditions Intrauterine fetal demise	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Renal and urinary disorders Pyelonephritis	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure with hypoxia	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Respiratory, thoracic and mediastinal disorders Shortness of breath	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Skin and subcutaneous tissue disorders Cellulitis	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Vascular disorders Hypertensive emergency	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.
Vascular disorders Orthostatic hypotension	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.
Vascular disorders Stroke	2.0% 1/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.	0.00% 0/50 • Adverse event data was collected for 6 months post-enrollment.