Trial Outcomes & Findings for Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney) (NCT NCT03149328)
NCT ID: NCT03149328
Last Updated: 2021-10-05
Results Overview
Assessed using the symptoms/problems domain of the Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36). The Symptoms/Problems domain has 12 items, each representing a symptom or side effect of kidney disease based on the past 4 weeks with 5 response items ranging from "Not Bothered at all = 100" to "Extremely Bothered = 0". Min Score = 0; Max score = 100. Higher score indicates better health.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
594 participants
Primary outcome timeframe
Trajectories of up to 24 months from start of enrollment to study completion
Results posted on
2021-10-05
Participant Flow
Patients who attended a home dialysis clinic in either the Aberhart Center in Edmonton (NARP), between August 28, 2017 \& August 30, 2019 or the Sheldon M Chumir Health Center in Calgary (SARP), between October 5, 2017 \& October 31, 2019 and who met the inclusion criteria were invited to participate in this study. Patients were excluded if they were under 18 years of age, could not read or speak English or could not provide informed consent.
Patients were recruited and placed into their arm based on the clinic they were attending - there was no random assignment. 51 participants were clinicians (48) and family caregivers (3), these 2 participants groups were not part of the trial portion of the study.
Participant milestones
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Overall Study
STARTED
|
284
|
259
|
|
Overall Study
COMPLETED
|
200
|
213
|
|
Overall Study
NOT COMPLETED
|
84
|
46
|
Reasons for withdrawal
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
30
|
26
|
|
Overall Study
Changed Dialysis Modality
|
18
|
1
|
|
Overall Study
Transplant
|
9
|
1
|
|
Overall Study
Lost to Follow-up
|
25
|
16
|
|
Overall Study
Left Study Site
|
1
|
2
|
|
Overall Study
Language Barrier
|
1
|
0
|
Baseline Characteristics
2 participants chose not to answer - missing data
Baseline characteristics by cohort
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=284 Participants
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=259 Participants
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinciains did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 13.3 • n=282 Participants • 2 participants chose not to answer - missing data
|
56.7 years
STANDARD_DEVIATION 14.2 • n=259 Participants • 2 participants chose not to answer - missing data
|
56.0 years
STANDARD_DEVIATION 13.8 • n=541 Participants • 2 participants chose not to answer - missing data
|
|
Sex: Female, Male
Female
|
97 Participants
n=282 Participants • 2 participants chose to not answer - missing data
|
88 Participants
n=259 Participants • 2 participants chose to not answer - missing data
|
185 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Sex: Female, Male
Male
|
185 Participants
n=282 Participants • 2 participants chose to not answer - missing data
|
171 Participants
n=259 Participants • 2 participants chose to not answer - missing data
|
356 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Aboriginal
|
23 Participants
n=284 Participants
|
9 Participants
n=259 Participants
|
32 Participants
n=543 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
42 Participants
n=284 Participants
|
62 Participants
n=259 Participants
|
104 Participants
n=543 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
196 Participants
n=284 Participants
|
159 Participants
n=259 Participants
|
355 Participants
n=543 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
4 Participants
n=284 Participants
|
10 Participants
n=259 Participants
|
14 Participants
n=543 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
14 Participants
n=284 Participants
|
6 Participants
n=259 Participants
|
20 Participants
n=543 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than one race/ethnicity
|
5 Participants
n=284 Participants
|
12 Participants
n=259 Participants
|
17 Participants
n=543 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown or not reported
|
0 Participants
n=284 Participants
|
1 Participants
n=259 Participants
|
1 Participants
n=543 Participants
|
|
Employment Status
Retired
|
77 Participants
n=283 Participants • 2 participants chose to not answer - missing data
|
95 Participants
n=258 Participants • 2 participants chose to not answer - missing data
|
172 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Employment Status
Unable to Work
|
82 Participants
n=283 Participants • 2 participants chose to not answer - missing data
|
61 Participants
n=258 Participants • 2 participants chose to not answer - missing data
|
143 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Employment Status
Working
|
89 Participants
n=283 Participants • 2 participants chose to not answer - missing data
|
76 Participants
n=258 Participants • 2 participants chose to not answer - missing data
|
165 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Employment Status
Other
|
35 Participants
n=283 Participants • 2 participants chose to not answer - missing data
|
26 Participants
n=258 Participants • 2 participants chose to not answer - missing data
|
61 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Highlest Level of Education
Elementary School
|
18 Participants
n=284 Participants • 2 participants chose to not answer - missing data
|
5 Participants
n=257 Participants • 2 participants chose to not answer - missing data
|
23 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Highlest Level of Education
High School Graduate
|
95 Participants
n=284 Participants • 2 participants chose to not answer - missing data
|
67 Participants
n=257 Participants • 2 participants chose to not answer - missing data
|
162 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Highlest Level of Education
College / Trade Diploma
|
101 Participants
n=284 Participants • 2 participants chose to not answer - missing data
|
113 Participants
n=257 Participants • 2 participants chose to not answer - missing data
|
214 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Highlest Level of Education
Undergraduate Degree
|
40 Participants
n=284 Participants • 2 participants chose to not answer - missing data
|
50 Participants
n=257 Participants • 2 participants chose to not answer - missing data
|
90 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Highlest Level of Education
Graduate Degree
|
25 Participants
n=284 Participants • 2 participants chose to not answer - missing data
|
18 Participants
n=257 Participants • 2 participants chose to not answer - missing data
|
43 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Highlest Level of Education
Other
|
5 Participants
n=284 Participants • 2 participants chose to not answer - missing data
|
4 Participants
n=257 Participants • 2 participants chose to not answer - missing data
|
9 Participants
n=541 Participants • 2 participants chose to not answer - missing data
|
|
Type of Dialysis
Peritoneal
|
199 Participants
n=282 Participants • 2 participants chose not to answer - missing data
|
187 Participants
n=259 Participants • 2 participants chose not to answer - missing data
|
386 Participants
n=541 Participants • 2 participants chose not to answer - missing data
|
|
Type of Dialysis
Home Hemodialysis
|
75 Participants
n=282 Participants • 2 participants chose not to answer - missing data
|
65 Participants
n=259 Participants • 2 participants chose not to answer - missing data
|
140 Participants
n=541 Participants • 2 participants chose not to answer - missing data
|
|
Type of Dialysis
Nocturnal
|
6 Participants
n=282 Participants • 2 participants chose not to answer - missing data
|
5 Participants
n=259 Participants • 2 participants chose not to answer - missing data
|
11 Participants
n=541 Participants • 2 participants chose not to answer - missing data
|
|
Type of Dialysis
Other
|
2 Participants
n=282 Participants • 2 participants chose not to answer - missing data
|
2 Participants
n=259 Participants • 2 participants chose not to answer - missing data
|
4 Participants
n=541 Participants • 2 participants chose not to answer - missing data
|
|
Diagnoses
Diabetes
|
116 Participants
n=284 Participants
|
83 Participants
n=259 Participants
|
199 Participants
n=543 Participants
|
|
Diagnoses
Hypertension
|
182 Participants
n=284 Participants
|
186 Participants
n=259 Participants
|
368 Participants
n=543 Participants
|
|
Diagnoses
Myocardial Infarction
|
27 Participants
n=284 Participants
|
26 Participants
n=259 Participants
|
53 Participants
n=543 Participants
|
|
Diagnoses
Heart Disease
|
39 Participants
n=284 Participants
|
26 Participants
n=259 Participants
|
65 Participants
n=543 Participants
|
|
Diagnoses
Stroke
|
16 Participants
n=284 Participants
|
10 Participants
n=259 Participants
|
26 Participants
n=543 Participants
|
|
Diagnoses
Leg Amputation
|
10 Participants
n=284 Participants
|
7 Participants
n=259 Participants
|
17 Participants
n=543 Participants
|
|
Diagnoses
Lung Disease
|
8 Participants
n=284 Participants
|
15 Participants
n=259 Participants
|
23 Participants
n=543 Participants
|
|
Diagnoses
Liver Disease
|
2 Participants
n=284 Participants
|
6 Participants
n=259 Participants
|
8 Participants
n=543 Participants
|
|
Diagnoses
Arthritis
|
38 Participants
n=284 Participants
|
49 Participants
n=259 Participants
|
87 Participants
n=543 Participants
|
|
Diagnoses
Cancer
|
22 Participants
n=284 Participants
|
13 Participants
n=259 Participants
|
35 Participants
n=543 Participants
|
|
Diagnoses
Lower Back Pain
|
43 Participants
n=284 Participants
|
40 Participants
n=259 Participants
|
83 Participants
n=543 Participants
|
|
Diagnoses
Depression
|
36 Participants
n=284 Participants
|
31 Participants
n=259 Participants
|
67 Participants
n=543 Participants
|
|
Diagnoses
Other
|
28 Participants
n=284 Participants
|
33 Participants
n=259 Participants
|
61 Participants
n=543 Participants
|
PRIMARY outcome
Timeframe: Trajectories of up to 24 months from start of enrollment to study completionPopulation: Intent to treat population (all participants assigned to Clinician Support and Education as well as Usual Care). Based on Imputed dataset.
Assessed using the symptoms/problems domain of the Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36). The Symptoms/Problems domain has 12 items, each representing a symptom or side effect of kidney disease based on the past 4 weeks with 5 response items ranging from "Not Bothered at all = 100" to "Extremely Bothered = 0". Min Score = 0; Max score = 100. Higher score indicates better health.
Outcome measures
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=1196 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=1056 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Symptoms - Trajectory of Change
|
77.2 score on a scale
Standard Deviation 14.2
|
76.2 score on a scale
Standard Deviation 15.1
|
PRIMARY outcome
Timeframe: Trajectories of up to 24 months from start of enrollment to study completionPopulation: Intent to treat population (all participants assigned to Clinician Support and Education as well as Usual Care). Based on Imputed dataset.
Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC-20), a patient-reported experience measure on satisfaction with care over the past 6 months. The PACIC-20 is a 20-item survey based on five subscales: (1) patient activation, (2) delivery system design and decision support, (3) goal setting and tailoring, (4) problem-solving and contextual counselling, and (5) follow-up and coordination. Each item is rated on a five-point scale (from "Almost never = 0" to "Almost always = 5") and the subscale and total scores are based on average scores across items. Min score = 0; Max score = 5. Higher scores indicates higher quality of care.
Outcome measures
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=1196 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=1056 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Person-centred Care - Trajectory of Change
|
3.4 score on a scale
Standard Deviation 1.1
|
3.5 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: From study enrollment until completion (up to 24 months)Population: Health data for 5 participants classified as intervention were not found in the Alberta Health Services Database
Assessed using health services data (i.e. average number of hospital admissions, trips to the emergency room) determined through SPOR Platform and Alberta Health Services electronic health records. Higher numbers indicates worse outcomes.
Outcome measures
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=279 Participants
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=259 Participants
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Utilization of Health Services
Hospitalizations
|
1.99 number of occurances
Standard Deviation 2.15
|
2.33 number of occurances
Standard Deviation 2.52
|
|
Utilization of Health Services
Emergency Room Visits
|
5.72 number of occurances
Standard Deviation 7.28
|
4.53 number of occurances
Standard Deviation 5.58
|
SECONDARY outcome
Timeframe: Up to 24 months from start of enrollment to study completionPopulation: Intent to treat population (all participants assigned to Clinician Support and Education as well as Usual Care). Based on Imputed dataset.
Assessed using one item added to the end of the Patient Assessment of Care for Chronic Conditions 20 item questionnaire (PACIC-20) related to care received. This item is from the NHS Outpatient Survey (2011). (RateClin) related to care received on a Likert-type scale from Excellent = 1 to Very Poor = 6. Min = 1, max = 6. The number of patients who selected "1 - Excellent" was tabulated and compared between the two groups. The higher the number the more patients who felt the care provided to them was excellent.
Outcome measures
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=1196 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=1056 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Number of Participants Who Selected "1 - Excellent" on Satisfaction With Care
|
654 Patient Reported Outcome Surveys
|
547 Patient Reported Outcome Surveys
|
SECONDARY outcome
Timeframe: Trajectories of up to 24 months from start of enrollment to study completionPopulation: Intent to treat population (all participants assigned to Clinician Support and Education as well as Usual Care). Based on Imputed dataset.
Assessed using the SF-12 mental component summary (MCS) subscale in the Kidney Disease Quality of Life 36-item Short-Form Survey (KDQOL-36). The SF-12 uses 2 items (psychological distress and psychological well being) to measure the MCS score. The summary score is transformed using Canadian norm-based scoring. The scores ranged from 0 (worst health) to 100 (best health). The higher the score the better the mental health.
Outcome measures
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=1196 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=1056 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Mental Health - Trajectory of Change
|
50.9 score on a scale
Standard Deviation 8.4
|
51.0 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Trajectories of up to 24 months from start of enrollment to study completionPopulation: Intent to treat population (all participants assigned to Clinician Support and Education as well as Usual Care). Based on Imputed dataset.
Assessed using the Euro Quality of Life EQ-5D-5L. This assessment uses a descriptive system for health-related Quality of Life states in adults consisting of 5 dimensions; Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is scored between 1 = indicating no problem and 5 = indicating unable to/extreme problems. An EQ-5D summary index is derived by applying a formula (the Canadian standard value set) that attaches values (weights) to each of the levels in each dimension. Index min= 0.0 max = 1.0. The higher the index the better the quality of life/state of health.
Outcome measures
| Measure |
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
n=1196 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePRO) every three months, the ePRO results for the ESASr were given to the nurse and placed in the patient chart (paper and electronic). This process helps to facilitate real time Patient Reported Outcomes (PRO) data collection and feedback in clinical practice.
Educational Training and Support was provided to the multidisciplinary home dialysis clinicians on how to use the results of the patient completed ePROs routinely in their practice to support ongoing patient care.
Kidney Patient Population: Northern Alberta Renal Program (NARP)
|
Usual Care
n=1056 Patient Reported Outcome Surveys
In this study arm home dialysis clinic patient participants completed Electronic Patient Reported Outcome Measures (ePROs) every 3 months for study comparison data but this information was not shared with the home dialysis clinic clinicians and the clinicians did not have access to participant's assessment responses.
Kidney Patient Population: Southern Alberta Renal Program (SARP)
|
|---|---|---|
|
Quality of Life - Trajectory of Change
|
0.772 score on a scale
Standard Deviation 0.182
|
0.745 score on a scale
Standard Deviation 0.196
|
Adverse Events
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 23 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place