Trial Outcomes & Findings for Remote Pulmonary Function Testing and Nurse Coaching in ALS (NCT NCT04490148)
NCT ID: NCT04490148
Last Updated: 2024-07-24
Results Overview
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of remote measurement of FVC 50% or less of the predicted value is reported here.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
1 year
Results posted on
2024-07-24
Participant Flow
5 participants exited the study prior to randomization.
Participant milestones
| Measure |
Remote Pulmonary Function Testing (rPFT) Longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
|
Remote Pulmonary Function Testing (rPFT) + Nurse Coaching Longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an amyotrophic lateral sclerosis (ALS) nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
17
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Remote PFT (rPFT) Longitudinal
n=12 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=12 Participants
|
65 years
n=17 Participants
|
64 years
n=29 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=12 Participants
|
10 Participants
n=17 Participants
|
14 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=12 Participants
|
7 Participants
n=17 Participants
|
15 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
17 participants
n=17 Participants
|
29 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Subset of patients include those who have a date of identification of NIV need from both remote PFT monitoring and standard PFT monitoring. Groups are combined because inferences across groups with respect to this outcome were not planned and are not reported.
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of remote measurement of FVC 50% or less of the predicted value is reported here.
Outcome measures
| Measure |
Total Group
n=7 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Date of Identification of Noninvasive Ventilation (NIV) Need From rPFT Monitoring
|
176 days after enrollment
Interval 36.0 to 365.0
|
—
|
PRIMARY outcome
Timeframe: From date of enrollment until first identification of non-invasive ventilation need, assessed up to 1.5 yearsPopulation: Subset of patients include those who have a date of identification of NIV need from both remote PFT monitoring and standard monitoring.
NIV is typically prescribed when an individual demonstrates signs of respiratory failure. In this study, forced vital capacity (FVC) of 50% or less of the predicted value serves as a surrogate for respiratory failure and constitutes identification of NIV need. First date of standard, in-clinic measurement of FVC 50% or less of the predicted value is reported here.
Outcome measures
| Measure |
Total Group
n=7 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Date of Identification of NIV Need From Standard PFT Monitoring
|
259 days after enrollment
Interval 76.0 to 413.0
|
—
|
PRIMARY outcome
Timeframe: 1 yearThe self-efficacy assessment contains questions from the Patient-Reported Outcomes Measurement Information System (PROMIS) item banks on Self-Efficacy for Managing Medications and Treatments (4 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Self-efficacy for Managing Medications and Treatments
|
-.238 points per month
Standard Deviation .393
|
.474 points per month
Standard Deviation 1.583
|
PRIMARY outcome
Timeframe: 1 yearThe self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Social Interactions (5 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Self-efficacy for Managing Social Interactions
|
-.041 points per month
Standard Deviation .551
|
-.181 points per month
Standard Deviation .688
|
PRIMARY outcome
Timeframe: 1 yearThe self-efficacy assessment contains questions from the PROMIS item bank on Self-Efficacy for Managing Symptoms (9 items). Cumulative T-scores from each test bank were reported at months 0, 3, 6, 9, and 12, with a mean score of 50±10, higher numbers indicating greater self-efficacy. The reported value is the slope of regression of self-efficacy on time, in T-score points per month.
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Self-efficacy for Managing Symptoms
|
-.279 points per month
Standard Deviation .636
|
-.255 points per month
Standard Deviation .813
|
SECONDARY outcome
Timeframe: 1 yearPatient-Reported Outcomes Measurement Information System (PROMIS) Pool v1.0 - Dyspnea Characteristics (5 items), which uses Likert-type scaling that are summed to a total score. Participants complete this questionnaire each month (12 total administrations). Total score range 0-44, with higher numbers indicating more severe dyspnea. The reported value is the slope of regression of total score on time, in point change per month.
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Dyspnea Characteristics
|
.029 points per month
Standard Deviation .408
|
.272 points per month
Standard Deviation .964
|
SECONDARY outcome
Timeframe: 1 yearSubjects were asked to report whether they experienced the following symptoms in the past month during each month on the study (12 administrations): excessive secretions, drooling, choking on secretions, morning headache. Reported value is the sum of experienced symptoms (0-4) summed over 12 months. Participants could experience none of these symptoms (0) up to experiencing all symptoms each month (48).
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Respiratory-related Symptoms
|
11.4 number of symptoms reported
Standard Deviation 6.4
|
7.6 number of symptoms reported
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 1 yearParticipant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report.
Outcome measures
| Measure |
Total Group
n=29 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
rPFT Adherence
|
82.2 Percentage
Interval 36.7 to 99.0
|
—
|
SECONDARY outcome
Timeframe: 1 yearPatient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Dyspnea Functional Limitations - Short Form 10a (10 items), which uses Likert-type scaling that are summed to a total score. Participants complete this questionnaire each month (12 total administrations). Total score range 0-30, with higher numbers indicating more functional limitations due to dyspnea. The reported value is the slope of regression of total score on time, in point change per month.
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Dyspnea Functional Limitations
|
-.022 points per month
Standard Deviation .350
|
-.255 points per month
Standard Deviation .838
|
SECONDARY outcome
Timeframe: 1 yearPatient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Sleep Related Impairment - Short Form 8a (8 items), which uses Likert-type scaling that are summed to a total score. Participants complete this questionnaire each month (12 total administrations). Total score range 8-40, with higher numbers indicating more sleep-related impairment. The reported value is the slope of regression of total score on time, in point change per month.
Outcome measures
| Measure |
Total Group
n=12 Participants
The full cohort from both arms of the study. There was no comparison of the primary outcome across groups.
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 Participants
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Sleep Related Impairment
|
.095 points per month
Standard Deviation .320
|
.140 points per month
Standard Deviation .523
|
Adverse Events
Remote PFT (rPFT) Longitudinal
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Remote PFT (rPFT) + Nurse Coaching Longitudinal
Serious events: 6 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Remote PFT (rPFT) Longitudinal
n=12 participants at risk
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
|
Remote PFT (rPFT) + Nurse Coaching Longitudinal
n=17 participants at risk
Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
remote pulmonary function testing: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
standard pulmonary function testing: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
Nurse Respiratory Health Coaching (NRHC): Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. \[Bennett2010\], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death due to respiratory failure
|
8.3%
1/12 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/12 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
|
Blood and lymphatic system disorders
Anasarca
|
0.00%
0/12 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
|
Vascular disorders
Stroke
|
0.00%
0/12 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
|
Injury, poisoning and procedural complications
Fall and Concussion
|
0.00%
0/12 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/12 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected at site visits as well as through participant self report between visits while the subject was on the study. This occurred over the course of one year on average.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place