Trial Outcomes & Findings for Connect-Home Clinical Trial (NCT NCT03810534)
NCT ID: NCT03810534
Last Updated: 2022-08-23
Results Overview
The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
654 participants
Primary outcome timeframe
7 Days After SNF Discharge
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
SNF 1
Connect-Home intervention at skilled nursing facility (SNF) 1.
Participants at this SNF enter the Standard of Care phase for 5 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 11 months.
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
|
SNF 2
Connect-Home intervention at skilled nursing facility (SNF) 2.
Participants at this SNF enter the Standard of Care phase for 6 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 10 months.
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
|
SNF 3
Connect-Home intervention at skilled nursing facility (SNF) 3.
Participants at this SNF enter the Standard of Care phase for 7 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 9 months.
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
|
SNF 4
Connect-Home intervention at skilled nursing facility (SNF) 4.
Participants at this SNF enter the Standard of Care phase for 8 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 8 months.
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
|
SNF 5
Connect-Home intervention at skilled nursing facility (SNF) 5.
Participants at this SNF enter the Standard of Care phase for 9 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 7 months.
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
|
SNF 6
Connect-Home intervention at skilled nursing facility (SNF) 6.
Participants at this SNF enter the Standard of Care phase for 10 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 6 months.
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
|
|---|---|---|---|---|---|---|
|
Standard of Care (5-10 Months)
STARTED
|
40
|
46
|
54
|
62
|
34
|
88
|
|
Standard of Care (5-10 Months)
Patients Started
|
20
|
23
|
27
|
31
|
17
|
44
|
|
Standard of Care (5-10 Months)
Caregivers Started
|
20
|
23
|
27
|
31
|
17
|
44
|
|
Standard of Care (5-10 Months)
Completed 7-day (Patients)
|
16
|
20
|
23
|
29
|
13
|
40
|
|
Standard of Care (5-10 Months)
Completed 7-Day (Caregivers)
|
18
|
21
|
23
|
29
|
13
|
38
|
|
Standard of Care (5-10 Months)
Completed 30-day (Patients)
|
14
|
16
|
21
|
23
|
12
|
38
|
|
Standard of Care (5-10 Months)
Completed 30-Day (Caregivers)
|
14
|
16
|
21
|
23
|
10
|
32
|
|
Standard of Care (5-10 Months)
Completed 60-Day (Patients)
|
10
|
16
|
17
|
20
|
10
|
32
|
|
Standard of Care (5-10 Months)
Completed 60-Day (Caregivers)
|
10
|
16
|
15
|
20
|
9
|
31
|
|
Standard of Care (5-10 Months)
COMPLETED
|
20
|
32
|
32
|
40
|
19
|
63
|
|
Standard of Care (5-10 Months)
NOT COMPLETED
|
20
|
14
|
22
|
22
|
15
|
25
|
|
Pre-Implementation Phase (2 Months)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Patients Started
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Caregivers Started
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Completed 7-Day (Patients)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Completed 7-Day (Caregivers)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Completed 30-Day (Patients)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Completed 30-Day (Caregivers)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Completed 60-Day (Patients)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
Completed 60-Day (Caregivers)
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Implementation Phase (2 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Connect-Home (5-10 Months)
STARTED
|
82
|
80
|
66
|
54
|
10
|
38
|
|
Connect-Home (5-10 Months)
Patients Started
|
41
|
40
|
33
|
27
|
5
|
19
|
|
Connect-Home (5-10 Months)
Caregivers Started
|
41
|
40
|
33
|
27
|
5
|
19
|
|
Connect-Home (5-10 Months)
Completed 7-Day (Patients)
|
38
|
35
|
27
|
23
|
4
|
14
|
|
Connect-Home (5-10 Months)
Completed 7-Day (Caregivers)
|
35
|
34
|
29
|
24
|
4
|
13
|
|
Connect-Home (5-10 Months)
Completed 30-Day (Patients)
|
35
|
31
|
25
|
19
|
3
|
12
|
|
Connect-Home (5-10 Months)
Completed 30-Day (Caregivers)
|
34
|
30
|
25
|
21
|
2
|
10
|
|
Connect-Home (5-10 Months)
Completed 60-Day (Patients)
|
30
|
25
|
23
|
19
|
2
|
10
|
|
Connect-Home (5-10 Months)
Completed 60-Day (Caregivers)
|
32
|
27
|
21
|
19
|
2
|
9
|
|
Connect-Home (5-10 Months)
COMPLETED
|
62
|
52
|
44
|
38
|
4
|
19
|
|
Connect-Home (5-10 Months)
NOT COMPLETED
|
20
|
28
|
22
|
16
|
6
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Connect-Home Clinical Trial
Baseline characteristics by cohort
| Measure |
Connect-Home Patients
n=165 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Connect-Home Caregivers
n=165 Participants
Caregivers of Connect-Home study patients.
|
Control Patients
n=162 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control Caregivers
n=162 Participants
Caregivers of Control study patients.
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
76.5 Years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 14.02 • n=7 Participants
|
76.6 Years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 13.72 • n=4 Participants
|
76.5 Years
STANDARD_DEVIATION 9.51 • n=21 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
444 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
654 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
472 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
165 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
654 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 Days After SNF DischargePopulation: Data reported for participants who answered the 7-day data collection phone call.
The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.
Outcome measures
| Measure |
Connect-Home
n=142 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=141 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge
|
75.80 score on a scale
Standard Deviation 16.08
|
68.33 score on a scale
Standard Deviation 17.69
|
PRIMARY outcome
Timeframe: 7 Days After Patient SNF DischargeThe caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.
Outcome measures
| Measure |
Connect-Home
n=140 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=141 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge
|
23.14 score on a scale
Standard Deviation 6.74
|
19.26 score on a scale
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: 30 Days After SNF DischargeThe patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.
Outcome measures
| Measure |
Connect-Home
n=100 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=91 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge
|
7.69 score on a scale
Standard Deviation 1.81
|
7.69 score on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 60 Days After SNF DischargeThe patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.
Outcome measures
| Measure |
Connect-Home
n=88 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=81 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge
|
7.81 score on a scale
Standard Deviation 1.58
|
7.71 score on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: 30 Days After SNF DischargePatient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.
Outcome measures
| Measure |
Connect-Home
n=124 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=125 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Life Space Assessment 30 Days After Skilled Nursing Facility Discharge
|
22.18 score on a scale
Standard Deviation 16.67
|
22.97 score on a scale
Standard Deviation 15.38
|
SECONDARY outcome
Timeframe: 60 Days After SNF DischargePatient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.
Outcome measures
| Measure |
Connect-Home
n=108 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=105 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Life Space Assessment 60 Days After Skilled Nursing Facility Discharge
|
25.55 score on a scale
Standard Deviation 17.41
|
28.60 score on a scale
Standard Deviation 18.55
|
SECONDARY outcome
Timeframe: 30 Days After Patient's SNF DischargeCaregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.
Outcome measures
| Measure |
Connect-Home
n=120 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=118 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge
|
12.27 score on a scale
Standard Deviation 9.77
|
12.33 score on a scale
Standard Deviation 10.33
|
SECONDARY outcome
Timeframe: 60 Days After Patient's SNF DischargeCaregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.
Outcome measures
| Measure |
Connect-Home
n=106 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=102 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge
|
11.84 score on a scale
Standard Deviation 9.40
|
11.35 score on a scale
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: 30 Days After Patient's SNF DischargeCaregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \>4 associated with poor coping and depression.
Outcome measures
| Measure |
Connect-Home
n=118 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=118 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Distress Thermometer 30 Days After Skilled Nursing Facility Discharge
|
3.19 score on a scale
Standard Deviation 2.66
|
3.02 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: 60 Days After Patient's SNF DischargeCaregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores \>4 associated with poor coping and depression.
Outcome measures
| Measure |
Connect-Home
n=105 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=102 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Distress Thermometer 60 Days After Skilled Nursing Facility Discharge
|
3.03 score on a scale
Standard Deviation 3.07
|
2.60 score on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: 30 Days After SNF DischargePopulation: Data are reported only for participants who had acute care use.
Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.
Outcome measures
| Measure |
Connect-Home
n=135 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=130 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge
|
.65 Days
Standard Deviation 1.82
|
1.01 Days
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: 60 Days After SNF DischargePopulation: Data are reported only for participants who had acute care use.
Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.
Outcome measures
| Measure |
Connect-Home
n=136 Participants
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control
n=131 Participants
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
|
|---|---|---|
|
Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge
|
.82 Days
Standard Error 2.00
|
1.24 Days
Standard Error 3.61
|
Adverse Events
Connect-Home Patients
Serious events: 38 serious events
Other events: 0 other events
Deaths: 6 deaths
Connect-Home Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Patients
Serious events: 34 serious events
Other events: 0 other events
Deaths: 8 deaths
Control Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Connect-Home Patients
n=165 participants at risk
Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Connect-Home Caregivers
n=165 participants at risk
Caregivers of Connect-Home study patients.
|
Control Patients
n=162 participants at risk
Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
|
Control Caregivers
n=162 participants at risk
Caregivers of Control study patients.
|
|---|---|---|---|---|
|
General disorders
Hospitalization for generalized weakness
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
General disorders
Hospitalization Reason Undisclosed
|
1.8%
3/165 • Number of events 3 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
1.2%
2/162 • Number of events 2 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization for Racing Heart Issues
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Skin and subcutaneous tissue disorders
Hospitalization for Neck Laceration Caused by Fall
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Nervous system disorders
Hospitalization due to Mini Stroke
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
1.2%
2/162 • Number of events 2 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Renal and urinary disorders
Hospitalization due to Urinary Tract Infection
|
3.0%
5/165 • Number of events 5 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
2.5%
4/162 • Number of events 4 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Renal and urinary disorders
Hospitalization due to Kidney Issues
|
1.2%
2/165 • Number of events 2 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Nervous system disorders
Hospitalization Due to Acute Metabolic Encephalopathy
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization Due to Shortness of Breath
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
2.5%
4/162 • Number of events 4 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Low Blood Pressure
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Fluid Build-Up
|
1.2%
2/165 • Number of events 2 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Left Thoracentesis
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization Due to Fracture Subsequent to Fall
|
4.8%
8/165 • Number of events 8 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
2.5%
4/162 • Number of events 4 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Hepatobiliary disorders
Hospitalization Due to Gall Bladder Issues
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Atrial Fibrillation
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Cardiac Stent Placement
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Blood and lymphatic system disorders
Hospitalization Due to Sepsis
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Skin and subcutaneous tissue disorders
Hospitalization Due to Skin Infection
|
1.8%
3/165 • Number of events 3 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Vascular disorders
Hospitalization Due to Vasculitis
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Congestive Heart Failure
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Gastrointestinal disorders
Hospitalization Due to Colon Tear
|
0.61%
1/165 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization Due to Pneumonia
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
3.7%
6/162 • Number of events 6 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Gastrointestinal disorders
Hospitalization Due to Abdominal Pain
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Pulmonary Embolism
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization Due to Lower Extremity Weakness
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Nervous system disorders
Hospitalization Due to Tremors
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Surgical and medical procedures
Hospitalization Due to Toe Amputation
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
1.2%
2/162 • Number of events 2 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization Due to Leg Pain
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
|
Cardiac disorders
Hospitalization Due to Chest Pain
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/165 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.62%
1/162 • Number of events 1 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
0.00%
0/162 • Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Mark Toles, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-5684
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place