Trial Outcomes & Findings for Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME) (NCT NCT01992393)
NCT ID: NCT01992393
Last Updated: 2022-09-28
Results Overview
The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2022-09-28
Participant Flow
We used the electronic medical record from a large citywide healthcare system to preliminarily identify people with an epilepsy diagnosis and invited them to participate in the RCT.
14 participants were excluded at Screening because they did not meet the inclusion criteria: 4 No SMI, 2 No epilepsy, 3 No show (unwilling to participate), 3 withdrew from study, 1 Single episode SMI,1 Pregnancy
Participant milestones
| Measure |
TIME
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
This arm will receive treatment as usual.
|
|---|---|---|
|
Baseline
STARTED
|
22
|
22
|
|
Baseline
COMPLETED
|
21
|
22
|
|
Baseline
NOT COMPLETED
|
1
|
0
|
|
Week 12 (3 Months)
STARTED
|
21
|
22
|
|
Week 12 (3 Months)
COMPLETED
|
19
|
18
|
|
Week 12 (3 Months)
NOT COMPLETED
|
2
|
4
|
|
Week 16 (4 Months)
STARTED
|
19
|
18
|
|
Week 16 (4 Months)
COMPLETED
|
19
|
16
|
|
Week 16 (4 Months)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
Baseline characteristics by cohort
| Measure |
TIME
n=22 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=22 Participants
This arm will receive treatment as usual.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.00 years
STANDARD_DEVIATION 7.58 • n=93 Participants
|
45.10 years
STANDARD_DEVIATION 14.18 • n=4 Participants
|
48.25 years
STANDARD_DEVIATION 11.82 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Education Level
Less than a high school education
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Education Level
High school graduate, GED, or higher
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Employment Status
Unemployed
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Employment Status
Unable to work
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Employment Status
Other
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Employment Status
Data Missing
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Marital Status
Married
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Marital Status
Other
|
18 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Living Situation
Lives alone
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Living Situation
Only adult in household
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Living Situation
Lives with other adults
|
5 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Living Situation
Homeless
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Income Level
Less than $25,000
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Income Level
$25,000-$50,000
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Income Level
More than $50,000
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Seizure Type
Generalized
|
16 seizures
n=93 Participants
|
14 seizures
n=4 Participants
|
30 seizures
n=27 Participants
|
|
Seizure Type
Partial
|
5 seizures
n=93 Participants
|
6 seizures
n=4 Participants
|
11 seizures
n=27 Participants
|
|
Seizure Type
Unclassified
|
1 seizures
n=93 Participants
|
2 seizures
n=4 Participants
|
3 seizures
n=27 Participants
|
|
Seizure Type
Other
|
1 seizures
n=93 Participants
|
3 seizures
n=4 Participants
|
4 seizures
n=27 Participants
|
|
Seizure Type
Don't know/Not sure
|
1 seizures
n=93 Participants
|
4 seizures
n=4 Participants
|
5 seizures
n=27 Participants
|
|
Mental Health Diagnosis
Depression
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Mental Health Diagnosis
Bipolar Disorder
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Mental Health Diagnosis
Schizophrenia
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Duration of Mental Health Disorder (in years)
|
30.27 years
STANDARD_DEVIATION 17.35 • n=93 Participants
|
22.85 years
STANDARD_DEVIATION 12.33 • n=4 Participants
|
26.14 years
STANDARD_DEVIATION 15.76 • n=27 Participants
|
|
Duration of Epilepsy (in years)
|
27.55 years
STANDARD_DEVIATION 16.48 • n=93 Participants
|
25.43 years
STANDARD_DEVIATION 15.47 • n=4 Participants
|
26.27 years
STANDARD_DEVIATION 15.74 • n=27 Participants
|
|
Charlson Comorbidity Index (CCI)
|
3.14 scores on a scale
STANDARD_DEVIATION 2.47 • n=93 Participants
|
1.86 scores on a scale
STANDARD_DEVIATION 2.29 • n=4 Participants
|
2.45 scores on a scale
STANDARD_DEVIATION 2.44 • n=27 Participants
|
|
Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R)
|
5.18 scores on a scale
STANDARD_DEVIATION 2.77 • n=93 Participants
|
6.29 scores on a scale
STANDARD_DEVIATION 2.57 • n=4 Participants
|
5.77 scores on a scale
STANDARD_DEVIATION 2.69 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Individuals with epilepsy and comorbid mental illness.
The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression.
Outcome measures
| Measure |
TIME
n=22 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=22 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Week 16
|
11.21 score on a scale
Standard Deviation 9.36
|
21.81 score on a scale
Standard Deviation 10.50
|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Baseline
|
16.75 score on a scale
Standard Deviation 10.28
|
22.94 score on a scale
Standard Deviation 11.81
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assess functioning and disabilities in activities of daily living, including mobility, self-care, and life activities. Sum Scores from 32-180 with higher scores indicating greater degree of disability.
Outcome measures
| Measure |
TIME
n=21 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=19 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
World Health Organization Disability Assessment (WHODAS II)
Baseline
|
80.86 score on a scale
Standard Deviation 18.76
|
82.83 score on a scale
Standard Deviation 23.39
|
|
World Health Organization Disability Assessment (WHODAS II)
12 week
|
67.68 score on a scale
Standard Deviation 13.29
|
79.87 score on a scale
Standard Deviation 24.44
|
|
World Health Organization Disability Assessment (WHODAS II)
16 week
|
73.39 score on a scale
Standard Deviation 24.94
|
81.50 score on a scale
Standard Deviation 21.34
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems
Outcome measures
| Measure |
TIME
n=22 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=21 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Quality of Life Questionnaire (QOLIE-10)
Baseline
|
2.85 units on a scale
Standard Deviation 0.82
|
3.34 units on a scale
Standard Deviation 0.25
|
|
Quality of Life Questionnaire (QOLIE-10)
12 Week
|
2.38 units on a scale
Standard Deviation 0.60
|
3.03 units on a scale
Standard Deviation 0.79
|
|
Quality of Life Questionnaire (QOLIE-10)
16 Week
|
2.56 units on a scale
Standard Deviation 0.89
|
2.84 units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
Scores from 0-27 with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
TIME
n=20 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=21 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Baseline
|
9.70 score on a scale
Standard Deviation 5.55
|
11.76 score on a scale
Standard Deviation 5.72
|
|
Patient Health Questionnaire (PHQ-9)
12 Week
|
9.24 score on a scale
Standard Deviation 4.97
|
13.19 score on a scale
Standard Deviation 5.67
|
|
Patient Health Questionnaire (PHQ-9)
16 Week
|
6.38 score on a scale
Standard Deviation 4.44
|
12.87 score on a scale
Standard Deviation 6.63
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality).
Outcome measures
| Measure |
TIME
n=20 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=20 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
10.55 score on a scale
Standard Deviation 4.49
|
12.95 score on a scale
Standard Deviation 4.38
|
|
Pittsburgh Sleep Quality Index (PSQI)
12 Week
|
8.88 score on a scale
Standard Deviation 3.30
|
12.21 score on a scale
Standard Deviation 2.64
|
|
Pittsburgh Sleep Quality Index (PSQI)
16 Week
|
6.85 score on a scale
Standard Deviation 3.80
|
11.45 score on a scale
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms.
Outcome measures
| Measure |
TIME
n=21 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=20 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS)
12 Week
|
33.89 score on a scale
Standard Deviation 9.67
|
35.81 score on a scale
Standard Deviation 11.24
|
|
Brief Psychiatric Rating Scale (BPRS)
16 Week
|
29.59 score on a scale
Standard Deviation 11.36
|
35.73 score on a scale
Standard Deviation 9.63
|
|
Brief Psychiatric Rating Scale (BPRS)
Baseline
|
36.90 score on a scale
Standard Deviation 11.78
|
37.85 score on a scale
Standard Deviation 10.39
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning.
Outcome measures
| Measure |
TIME
n=22 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=21 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Global Assessment of Functioning (GAF)
Baseline
|
59.23 score on a scale
Standard Deviation 17.06
|
54.57 score on a scale
Standard Deviation 13.66
|
|
Global Assessment of Functioning (GAF)
12 Week
|
62.83 score on a scale
Standard Deviation 15.98
|
59.00 score on a scale
Standard Deviation 16.78
|
|
Global Assessment of Functioning (GAF)
16 Week
|
69.50 score on a scale
Standard Deviation 18.27
|
59.94 score on a scale
Standard Deviation 18.38
|
SECONDARY outcome
Timeframe: Baseline, 12 Week, 16 WeekPopulation: Individuals with epilepsy and comorbid mental illness with available data.
Self reported seizure frequency in the past 30 days
Outcome measures
| Measure |
TIME
n=18 Participants
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=16 Participants
This arm will receive treatment as usual.
|
|---|---|---|
|
Seizure Frequency - Past 30 Days
Baseline
|
3.67 number of seizures
Standard Deviation 14.08
|
8.79 number of seizures
Standard Deviation 32.01
|
|
Seizure Frequency - Past 30 Days
16 Week
|
1.00 number of seizures
Standard Deviation 1.97
|
6.44 number of seizures
Standard Deviation 15.21
|
|
Seizure Frequency - Past 30 Days
12 Week
|
1.50 number of seizures
Standard Deviation 2.68
|
18.40 number of seizures
Standard Deviation 42.36
|
Adverse Events
TIME
Serious events: 12 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIME
n=22 participants at risk
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=22 participants at risk
This arm will receive treatment as usual.
|
|---|---|---|
|
Nervous system disorders
Suicide attempt
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Nervous system disorders
Seizures
|
18.2%
4/22 • Number of events 4 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Cardiac disorders
Heart condition
|
13.6%
3/22 • Number of events 3 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Blood and lymphatic system disorders
Blood Sugar
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Cardiac disorders
Mini Stroke
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Injury, poisoning and procedural complications
Limb amputation
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
Surgical and medical procedures
Circulatory Surgery
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
Other adverse events
| Measure |
TIME
n=22 participants at risk
This arm will receive the TIME intervention.
TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
|
Treatment as Usual (TAU)
n=22 participants at risk
This arm will receive treatment as usual.
|
|---|---|---|
|
Surgical and medical procedures
Surgeries
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
|
General disorders
Foot issue
|
4.5%
1/22 • Number of events 1 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
0.00%
0/22 • All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
|
Additional Information
Joy Yala, Data & Regulatory Coordinator II
Case Western Reserve University
Phone: 216-368-0783
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place