Trial Outcomes & Findings for Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II (NCT NCT07205367)
NCT ID: NCT07205367
Last Updated: 2026-08-05
Results Overview
This outcome measure is met if the mean wear duration is greater than 21 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
21 - 30 days after baseline
Results posted on
2026-08-05
Participant Flow
This trial had 2 phases; 75 participants were in each phase. An external vendor conducted recruitment 02Dec24 - 31Jan25 for Phase I \& 07May25 - 06Jun25 for Phase II. The same recruitment methods (IRB-approved email solicitation \& social media posting) were used for each phase. A study population representative of the intended Zio monitor use \& those who met eligibility criteria were approached. Enrolled participants were seen at 1 of 2 Sponsor locations (San Francisco, CA or Deerfield, IL).
Participant milestones
| Measure |
Open Label - Phase I Participants
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
72
|
64
|
|
Overall Study
NOT COMPLETED
|
3
|
11
|
Reasons for withdrawal
| Measure |
Open Label - Phase I Participants
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Early detachment / Device fall off
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
Baseline characteristics by cohort
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 18 - 50 years
|
8 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
22 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
30 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Age, Customized
Age · 51 - 70 years
|
43 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
29 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
72 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Age, Customized
Age · > 70 years
|
24 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
20 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
44 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Sex: Female, Male
Sex · Female
|
40 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
34 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
74 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Sex: Female, Male
Sex · Male
|
35 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
37 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
72 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
5 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
11 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
16 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
70 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
60 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
130 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
0 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
1 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
1 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · Asian
|
13 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
7 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
20 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
0 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · Black or African American
|
7 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
9 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
16 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · White
|
52 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
51 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
103 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · More than one race
|
3 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
3 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
6 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
0 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
0 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Region of Enrollment
United States
|
75 participants
n=20 Participants • Seventy-five (75) participants from Phase I and 71 from Phase II were included in the performance analysis population. Participant visits for both phases occurred at the Deerfield, IL or San Francisco, CA locations.
|
71 participants
n=20 Participants • Seventy-five (75) participants from Phase I and 71 from Phase II were included in the performance analysis population. Participant visits for both phases occurred at the Deerfield, IL or San Francisco, CA locations.
|
146 participants
n=40 Participants • Seventy-five (75) participants from Phase I and 71 from Phase II were included in the performance analysis population. Participant visits for both phases occurred at the Deerfield, IL or San Francisco, CA locations.
|
|
Patch Application Method
Health Care Provider or Designee
|
50 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
44 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
94 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
|
Patch Application Method
Self Application
|
25 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
27 Participants
n=20 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
52 Participants
n=40 Participants • The number of participants included in the performance analysis is 75 in Phase I and 71 in Phase II.
|
PRIMARY outcome
Timeframe: 21 - 30 days after baselinePopulation: The number of days of wear when the device is attached to the participants skin (beginning at the time of device application and ending at the 30-day follow-up visit or when the device failed to adequately adhere to the skin) was assessed for 75 participants in Phase I and 71 participants in Phase II.
This outcome measure is met if the mean wear duration is greater than 21 days
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Mean Wear Duration
|
27.1 number of days
Interval 26.4 to 27.8
|
26.4 number of days
Interval 25.3 to 27.5
|
PRIMARY outcome
Timeframe: Up to 30 days (Day 30)Population: The percentage of analyzable time during the wear of the device which yields analyzable ECG signal (i.e., free from signal artifact), was assessed in 75 participants in Phase I and 71 participants in Phase II.
This outcome measure is met if the percent analyzable time is greater than 80% in 90% of subjects.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Percent Analyzable Time
|
94.7 percentage of analyzable time
Interval 93.5 to 96.0
|
96.1 percentage of analyzable time
Interval 94.3 to 97.8
|
PRIMARY outcome
Timeframe: Up to 30 days (Day 30)Population: Skin irritation through 30 days of wear was evaluated with a skin assessment at Visits 1 (Baseline), 4 (Day 21) and 5 (Day 30). There were 75 participants analyzed in Phase I and 71 participants analyzed in Phase II. The data is presented as the number of participants who experienced reactions at Visits 1, 4 and 5.
This includes the proportion of participants that experience clinically significant skin irritation through 30 days of wear. This will be assessed through the capture and reporting of all adverse events.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Safety: Skin Irritation
Visit 5: Negative Reaction
|
34 Participants
|
13 Participants
|
|
Safety: Skin Irritation
Visit 1: Negative Reaction
|
64 Participants
|
71 Participants
|
|
Safety: Skin Irritation
Visit 1: Doubtful Reaction
|
9 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 1: Irritant Reaction of Different Type
|
1 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 1: Weak Positive Reaction
|
1 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 1: Strong Positive Reaction
|
0 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 1: Extreme Positive Reaction
|
0 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 4: Negative Reaction
|
67 Participants
|
64 Participants
|
|
Safety: Skin Irritation
Visit 4: Doubtful Reaction
|
1 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 4: Irritant Reaction of Different Type
|
6 Participants
|
2 Participants
|
|
Safety: Skin Irritation
Visit 4: Weak Positive Reaction
|
0 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 4: Strong Positive Reaction
|
0 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 4: Extreme Positive Reaction
|
0 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 5: Doubtful Reaction
|
7 Participants
|
36 Participants
|
|
Safety: Skin Irritation
Visit 5: Irritant Reaction of Different Type
|
22 Participants
|
12 Participants
|
|
Safety: Skin Irritation
Visit 5: Weak Positive Reaction
|
4 Participants
|
4 Participants
|
|
Safety: Skin Irritation
Visit 5: Strong Positive Reaction
|
5 Participants
|
0 Participants
|
|
Safety: Skin Irritation
Visit 5: Extreme Positive Reaction
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days (Day 30)Population: The proportion of ECG signal that is artifact (disturbance on the ECG that doesn't represent true electrical activity of the heart) obtained during wear time, was reported for each study device in 75 participants in Phase I and 71 participants in Phase II.
Percent signal artifact is defined as the proportion of ECG signal that is artifact over the wear duration, reported for each study device. Signal artifact is a continuous value representing the percentage of the wear duration that was not interpretable. This variable will be calculated as the inverse of analyzable ECG percent. Signal artifact will be summarized using the population meeting protocol requirements and include means and 95% confidence intervals for these proportions.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Additional Device Measure 1: Signal Artifact
|
5.3 percentage of time signal artifact
Interval 4.1 to 6.5
|
3.9 percentage of time signal artifact
Interval 2.2 to 5.7
|
SECONDARY outcome
Timeframe: At 21 days (Day 21) and 30 days (Day 30)Population: Device functionality is an assessment of devices that were adhered to the skin, were operational and recording ECG at the time of removal during the study.
Device functionality is defined as the number of participants with Zio monitors recording a continuous ECG signal through 21 and 30 days. The ability to record a continuous ECG signal is defined as device functionality. Device functionality will be determined by the number of participants with devices adhering to the skin, the number of participants with devices functioning/operating and the number of participants with devices that are recording and ECG signal.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Additional Device Measure 2: Device Functionality
21 Days
|
72 # participants with functioning devices
|
64 # participants with functioning devices
|
|
Additional Device Measure 2: Device Functionality
27 - 30 Days
|
59 # participants with functioning devices
|
58 # participants with functioning devices
|
|
Additional Device Measure 2: Device Functionality
30 Days
|
7 # participants with functioning devices
|
5 # participants with functioning devices
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Skin type characteristics were assessed in 75 participants in Phase I and 71 participants in Phase II.
This includes an assessment of the following skin types: dry, oily and normal.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Observational Assessment: Skin Dryness Level
Normal
|
55 Participants
|
46 Participants
|
|
Observational Assessment: Skin Dryness Level
Dry
|
20 Participants
|
22 Participants
|
|
Observational Assessment: Skin Dryness Level
Oily
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Hyperhydrosis status skin characteristics were assessed in 75 participants in Phase I and 71 participants in Phase II.
This includes an assessment of the following hyperhydrosis status: primary, secondary or none.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Observational Assessment: Hyperhydrosis Status
Primary
|
1 Participants
|
1 Participants
|
|
Observational Assessment: Hyperhydrosis Status
Secondary
|
2 Participants
|
0 Participants
|
|
Observational Assessment: Hyperhydrosis Status
None
|
72 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The Fitzpatrick Skin Type assessment questionnaire (types I to VI)) was completed in 75 participants in Phase I and 71 participants in Phase II.
This includes a 6-point scale to assess the following skin types: (1) pale skin; always burns, never tans; (2) fair skin; usually burns, tans minimally; (3) darker white skin; sometimes mild burn, tans uniformly; (4) light brown skin; burns minimally, always tans well; (5) brown skin; very rarely burns; tans very easily; (6) dark brown or black skin; never burns.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Observational Assessment: Fitzpatrick Skin Type
Type I
|
1 Participants
|
2 Participants
|
|
Observational Assessment: Fitzpatrick Skin Type
Type II
|
18 Participants
|
14 Participants
|
|
Observational Assessment: Fitzpatrick Skin Type
Type III
|
40 Participants
|
42 Participants
|
|
Observational Assessment: Fitzpatrick Skin Type
Type IV
|
11 Participants
|
10 Participants
|
|
Observational Assessment: Fitzpatrick Skin Type
Type V/VI
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: Chest hair density skin characteristics were assessed in 75 participants in Phase I and 71 participants in Phase II.
This includes an assessment of the following chest hair density types: smooth/no hair; some hair; moderately hairy; or very hairy in the target patch placement area.
Outcome measures
| Measure |
Open Label - Phase I Participants
n=75 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=71 Participants
This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Observational Assessment: Chest Hair Density
Smooth/No Hair
|
60 Participants
|
45 Participants
|
|
Observational Assessment: Chest Hair Density
Moderately Hairy
|
12 Participants
|
22 Participants
|
|
Observational Assessment: Chest Hair Density
Very Hairy
|
3 Participants
|
4 Participants
|
Adverse Events
Open Label - Phase I Participants
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Open Label - Phase II Participants
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label - Phase I Participants
n=75 participants at risk
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
Open Label - Phase II Participants
n=75 participants at risk
This is an open-label study. All 75 participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
Zio Monitor: The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Dryness
|
4.0%
3/75 • Number of events 3 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
46.7%
35/75 • Number of events 36 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
42.7%
32/75 • Number of events 33 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Erythematous macule
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.7%
2/75 • Number of events 2 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
2.7%
2/75 • Number of events 2 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Excoriations
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Irritated Burning
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Laceration/Superficial Laceration
|
2.7%
2/75 • Number of events 2 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
5.3%
4/75 • Number of events 4 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
25/75 • Number of events 26 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
48.0%
36/75 • Number of events 38 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Immune system disorders
Pyrexia
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Chalazion
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza/Influenza A
|
2.7%
2/75 • Number of events 2 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Erythematous Papular Eruption
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
10.7%
8/75 • Number of events 8 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Left Chest Soreness
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Eruption
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Papular Eruption
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
|
Skin and subcutaneous tissue disorders
Erythematous Macular Eruption
|
0.00%
0/75 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
1.3%
1/75 • Number of events 1 • Adverse event (AE) reporting began at the time of informed consent and continued until resolution, or Day 37, whichever was sooner.
All 150 participants (i.e., 75 on Phase I \& 75 on Phase II) were included in the safety analysis; none were excluded. AEs were reported by participants \& study staff. Participants were also provided a contact number to report any adverse events that occurred between planned visits. Safety Committee physicians reviewed all AEs to determine severity, relatedness, and whether anticipated or not. There were no serious adverse events (SAEs) reported during the course of the study for either phase.
|
Additional Information
Chevy Brown, Manager, Clinical Research Projects
iRhythm Technologies
Phone: 803-917-1551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place