Trial Outcomes & Findings for Promoting the Universal Medication Schedule Via Mobile and EHR Technologies (NCT NCT02248857)

NCT ID: NCT02248857

Last Updated: 2019-03-25

Results Overview

Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

452 participants

Primary outcome timeframe

6 months after baseline

Results posted on

2019-03-25

Participant Flow

Participant milestones

Participant milestones
Measure
Usual Care
Employ the current standard of care. No intervention.
UMS Strategy
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Baseline
STARTED
157
168
127
Baseline
COMPLETED
157
168
127
Baseline
NOT COMPLETED
0
0
0
3 Month
STARTED
157
168
127
3 Month
COMPLETED
111
134
96
3 Month
NOT COMPLETED
46
34
31
6 Month
STARTED
148
165
123
6 Month
COMPLETED
120
136
106
6 Month
NOT COMPLETED
28
29
17

Reasons for withdrawal

Reasons for withdrawal
Measure
Usual Care
Employ the current standard of care. No intervention.
UMS Strategy
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
3 Month
Withdrawal by Subject
9
3
4
3 Month
Unable to reach for 3 month
35
29
26
3 Month
Partially completed, unable to finish
2
2
1
6 Month
Lost to Follow-up
27
26
15
6 Month
Partially completed, unable to finish
0
1
0
6 Month
Withdrawal by Subject
0
2
2
6 Month
Death
1
0
0

Baseline Characteristics

Promoting the Universal Medication Schedule Via Mobile and EHR Technologies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Usual Care
n=157 Participants
Employ the current standard of care. No intervention.
UMS Strategy
n=168 Participants
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=127 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Total
n=452 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
131 Participants
n=5 Participants
142 Participants
n=7 Participants
95 Participants
n=5 Participants
368 Participants
n=4 Participants
Age, Categorical
>=65 years
26 Participants
n=5 Participants
26 Participants
n=7 Participants
32 Participants
n=5 Participants
84 Participants
n=4 Participants
Age, Continuous
56.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
56.4 years
STANDARD_DEVIATION 9.3 • n=7 Participants
57.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
56.7 years
STANDARD_DEVIATION 9.5 • n=4 Participants
Sex: Female, Male
Female
100 Participants
n=5 Participants
108 Participants
n=7 Participants
87 Participants
n=5 Participants
295 Participants
n=4 Participants
Sex: Female, Male
Male
57 Participants
n=5 Participants
60 Participants
n=7 Participants
40 Participants
n=5 Participants
157 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
113 Participants
n=5 Participants
127 Participants
n=7 Participants
91 Participants
n=5 Participants
331 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
43 Participants
n=5 Participants
41 Participants
n=7 Participants
36 Participants
n=5 Participants
120 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
5 Participants
n=4 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
6 Participants
n=7 Participants
1 Participants
n=5 Participants
10 Participants
n=4 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
Race (NIH/OMB)
Black or African American
32 Participants
n=5 Participants
27 Participants
n=7 Participants
23 Participants
n=5 Participants
82 Participants
n=4 Participants
Race (NIH/OMB)
White
112 Participants
n=5 Participants
130 Participants
n=7 Participants
96 Participants
n=5 Participants
338 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
14 Participants
n=4 Participants
Region of Enrollment
United States
157 participants
n=5 Participants
168 participants
n=7 Participants
127 participants
n=5 Participants
452 participants
n=4 Participants

PRIMARY outcome

Timeframe: 6 months after baseline

Population: All participants who completed the 6 month assessment and had complete data for the outcome for at least 1 medication.

Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.

Outcome measures

Outcome measures
Measure
Usual Care
n=559 Medications
Employ the current standard of care. No intervention.
UMS Strategy
n=611 Medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=455 Medications
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Prescription Understanding
0.81 Probability
Interval 0.77 to 0.84
0.82 Probability
Interval 0.79 to 0.85
0.78 Probability
Interval 0.74 to 0.82

SECONDARY outcome

Timeframe: 6 months after baseline

Population: All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication

Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.

Outcome measures

Outcome measures
Measure
Usual Care
n=611 Medications
Employ the current standard of care. No intervention.
UMS Strategy
n=654 Medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=488 Medications
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Medication Knowledge
0.21 Probability of medication knowledge
Interval 0.18 to 0.25
0.28 Probability of medication knowledge
Interval 0.25 to 0.32
0.26 Probability of medication knowledge
Interval 0.22 to 0.3

SECONDARY outcome

Timeframe: 6 months after baseline

Population: All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication

Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.

Outcome measures

Outcome measures
Measure
Usual Care
n=296 Medications
Employ the current standard of care. No intervention.
UMS Strategy
n=366 Medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=277 Medications
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Medication Adherence: Pill Count
0.41 Probability of adherence
Interval 0.35 to 0.47
0.31 Probability of adherence
Interval 0.27 to 0.36
0.34 Probability of adherence
Interval 0.29 to 0.4

SECONDARY outcome

Timeframe: 6 months after baseline

Population: All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication

Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.

Outcome measures

Outcome measures
Measure
Usual Care
n=609 Medications
Employ the current standard of care. No intervention.
UMS Strategy
n=654 Medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=487 Medications
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Medication Adherence: PMAQ
0.71 Probability of adherence
Interval 0.68 to 0.75
0.72 Probability of adherence
Interval 0.69 to 0.76
0.77 Probability of adherence
Interval 0.73 to 0.81

SECONDARY outcome

Timeframe: 6 months after baseline

Population: Participants who filled medications at Walgreens during the study period.

Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.

Outcome measures

Outcome measures
Measure
Usual Care
n=168 Medications
Employ the current standard of care. No intervention.
UMS Strategy
n=217 Medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=177 Medications
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Medication Adherence: Pharmacy Records
0.49 Probability of adherence
Interval 0.41 to 0.57
0.59 Probability of adherence
Interval 0.52 to 0.65
0.55 Probability of adherence
Interval 0.48 to 0.63

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months before baseline to 1 year after baseline

Population: All participants with both a baseline and 6 month systolic blood pressure measurement

An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).

Outcome measures

Outcome measures
Measure
Usual Care
n=94 Participants
Employ the current standard of care. No intervention.
UMS Strategy
n=115 Participants
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=91 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Changes in Blood Pressure
-1.4 mmHG
Standard Deviation 14.1
0.5 mmHG
Standard Deviation 14.0
0.1 mmHG
Standard Deviation 15.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months before baseline to 1 year after baseline

Population: All participants with both a baseline and 6 month hbA1c measurement

An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).

Outcome measures

Outcome measures
Measure
Usual Care
n=114 Participants
Employ the current standard of care. No intervention.
UMS Strategy
n=136 Participants
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=105 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Changes in Hemoglobin A1c (hbA1c)
-0.2 percent of glycated hemoglobin
Standard Deviation 1.3
-0.1 percent of glycated hemoglobin
Standard Deviation 1.5
-0.2 percent of glycated hemoglobin
Standard Deviation 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months before baseline to 1 year after baseline

Population: All participants with both a baseline and 6 month LDL measurement

An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).

Outcome measures

Outcome measures
Measure
Usual Care
n=19 Participants
Employ the current standard of care. No intervention.
UMS Strategy
n=29 Participants
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. 2. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
UMS Strategy + SMS Texting Reminders
n=9 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. SMS Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Changes in Low-density Lipoprotein Cholesterol (LDL)
-10.1 mg/dL
Standard Deviation 26.7
-17.1 mg/dL
Standard Deviation 66.5
-23.4 mg/dL
Standard Deviation 38.7

Adverse Events

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

UMS Strategy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

UMS Strategy + SMS Texting Reminders

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Wolf

Northwestern University

Phone: (312) 503-5592

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place