Trial Outcomes & Findings for Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) (NCT NCT02452892)
NCT ID: NCT02452892
Last Updated: 2017-12-05
Results Overview
Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline". Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Week 1 Day 4
Results posted on
2017-12-05
Participant Flow
12clinical study sites in the US recruited 122 subjects that were randomized into the study. The date of first subject enrollment was 03 September 2015 and the date of last subject enrolled was 22 July 2016.
Subject screening period was up to 14 days before receiving first study treatment. Subjects were contacted by an independent Massachusetts General Hospital-Clinical Trials Network and Institute (MGH-CTNI) rater to perform the Antidepressant Treatment Response Questionnaire (ATRQ) and SAFER assessments to confirm eligibility.
Participant milestones
| Measure |
LFMS Sham
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
LFMS 20 Minutes
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2, subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
LFMS 60 Minutes
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Week 1: Subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
LFMS 120 Min
Week 2: Subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
|---|---|---|---|---|
|
Week 1 Initial Randommization
STARTED
|
41
|
40
|
41
|
0
|
|
Week 1 Initial Randommization
COMPLETED
|
40
|
40
|
40
|
0
|
|
Week 1 Initial Randommization
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
Week 2 Stratification & Re-Randomization
STARTED
|
65
|
7
|
7
|
41
|
|
Week 2 Stratification & Re-Randomization
Non-reponders
|
38
|
0
|
0
|
41
|
|
Week 2 Stratification & Re-Randomization
Responders
|
27
|
7
|
7
|
0
|
|
Week 2 Stratification & Re-Randomization
COMPLETED
|
63
|
7
|
7
|
39
|
|
Week 2 Stratification & Re-Randomization
NOT COMPLETED
|
2
|
0
|
0
|
2
|
|
Follow-up
STARTED
|
63
|
7
|
7
|
39
|
|
Follow-up
COMPLETED
|
62
|
7
|
7
|
38
|
|
Follow-up
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
LFMS Sham
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
LFMS 20 Minutes
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2, subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
LFMS 60 Minutes
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Week 1: Subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
LFMS 120 Min
Week 2: Subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Week 1 subjects were randomly assigned using 1:1:1 allocation to LFMS Sham, LFMS 20 min., or LFMS 60 min. For Week 2 subjects were reassigned to LFMS Sham, LFMS 20min, LFMS 60min, or LFMS 120min. on the basis of their response to treatment received in Week 1 and their original treatment allocation.
|
|---|---|---|---|---|
|
Week 1 Initial Randommization
Adverse Event
|
1
|
0
|
0
|
0
|
|
Week 1 Initial Randommization
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Week 2 Stratification & Re-Randomization
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
Week 2 Stratification & Re-Randomization
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Follow-up
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Follow-up
Subject left town on Day 42
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
Baseline characteristics by cohort
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 120 Min
Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 1 Day 4Population: Subjects in the All Randomized set who completed at least one treatment session and had at least one post baseline primary efficacy assessment.
Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline". Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more.
Outcome measures
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.
|
-4.0 units on a scale
Interval -5.18 to -2.91
|
-4.2 units on a scale
Interval -5.34 to -3.04
|
-4.9 units on a scale
Interval -6.03 to -3.73
|
SECONDARY outcome
Timeframe: Day 11 (Week 2)Population: Only non-responders at end of Day 4 comprise this Wk 2 analysis . (Non-responders were defined as those who didn't reach a decrease in 6-item Hamilton Rating Scale for Depression (HAM-D6) total score of 50% compared to baseline Day 1, Week 1). 41 subjects entered Week 2: 1 subject withdrew consent on Day 8 and was not part of the Full Analysis Set.
Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4". To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11. Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more.
Outcome measures
| Measure |
LFMS Sham
n=38 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS
|
-2.6 units on a scale
Interval -3.6 to -1.68
|
-2.6 units on a scale
Interval -3.56 to -1.67
|
—
|
SECONDARY outcome
Timeframe: Day 42Population: Subjects who were HAM-D6 Day 4 responders, defined as those subjects who achieved a 50% or greater decrease in their HAM-D6 total score compared to Baseline ( Day1, Wk 1).
To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates.
Outcome measures
| Measure |
LFMS Sham
n=13 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=14 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=14 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score
|
53.8 percentage of LFMS responders
|
57.1 percentage of LFMS responders
|
78.6 percentage of LFMS responders
|
POST_HOC outcome
Timeframe: Day 4 Week 1Population: Full Analysis Set, Week1
The MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in subjects with Major Depressive Disorder (MDD). Individual items are rated on a scale of 0 to 6 in which a score of 6 represents the most severe symptoms for each item assessed. The total score ranges from 0 to 60. Remission of depression based on the MADRS is defined as a subject with a MADRS total score of ≤11 at endpoint. A responder on the MADRS is defined as a 50% or greater reduction from baseline in total MADRS score
Outcome measures
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)
|
-7.58 units on a scale
Interval -9.8 to -5.4
|
-8.09 units on a scale
Interval -10.3 to -5.8
|
-10.32 units on a scale
Interval -12.6 to -8.0
|
POST_HOC outcome
Timeframe: Day 4 Week 1Population: Full Analysis Set (Week 1).
The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Used as a psychometric scale, the PANAS can show relationships between positive and negative affect with personality stats and traits. Descriptors are used to define their meanings. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).To calculate the positive affect score, added scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, which higher scores representing higher levels of positive affect, or the extent to which the individual feels enthusiastic, active and alert.
Outcome measures
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score
|
1.67 units on a scale
Interval -0.29 to 3.62
|
3.62 units on a scale
Interval 1.63 to 5.62
|
3.24 units on a scale
Interval 1.23 to 5.26
|
POST_HOC outcome
Timeframe: Day 4, Week 1Population: Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.
The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome treated Item #2 as random missing data.
Outcome measures
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4
|
-2.27 units on a scale
Interval -4.2 to -0.34
|
-3.57 units on a scale
Interval -5.55 to -1.59
|
-5.32 units on a scale
Interval -7.31 to -3.33
|
POST_HOC outcome
Timeframe: Day 4Population: Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.
The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome treated Incorrect Item #2 where Item #2 data was removed.
Outcome measures
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4
|
-2.95 units on a scale
Interval -5.03 to -0.87
|
-3.78 units on a scale
Interval -5.94 to -1.59
|
-5.58 units on a scale
Interval -7.74 to -3.41
|
POST_HOC outcome
Timeframe: Day 4, Week 1Population: Full analysis set, Week 1.Item #2 was incorrectly listed as "Disinterested" instead of "Distressed".resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.
The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome approach took Incorrect Item #2 and imputed using worst possible value.
Outcome measures
| Measure |
LFMS Sham
n=41 Participants
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 Participants
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 Participants
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4
|
-2.29 units on a scale
Interval -4.24 to -0.34
|
-3.50 units on a scale
Interval -5.49 to -1.51
|
-5.36 units on a scale
Interval -7.36 to -3.36
|
Adverse Events
LFMS Sham
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
LFMS 20 Minutes
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
LFMS 60 Minutes
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LFMS 120 Min - Week 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LFMS Sham
n=79 participants at risk
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 20 Minutes
n=40 participants at risk
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 60 Minutes
n=41 participants at risk
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
LFMS 120 Min - Week 2
n=41 participants at risk
Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
LFMS: Low field magnetic stimulation (1 kHz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
|
|---|---|---|---|---|
|
Nervous system disorders
Headche
|
8.9%
7/79 • Number of events 10 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
15.0%
6/40 • Number of events 7 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
9.8%
4/41 • Number of events 4 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
9.8%
4/41 • Number of events 6 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
7.3%
3/41 • Number of events 3 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 2 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
General disorders
Fatigue
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
5.0%
2/40 • Number of events 2 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Psychiatric disorders
Insomnia
|
2.5%
2/79 • Number of events 2 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
4.9%
2/41 • Number of events 3 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
General disorders
Pyrexia
|
2.5%
2/79 • Number of events 2 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Gasrtoenteritis
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Gasrtoenteritis viral
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Upper respiratory tract infecrion
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
3/79 • Number of events 3 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 2 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
1/79 • Number of events 2 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Vascular disorders
Hypertension
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Investigations
Blood creatinine increased
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Psychiatric disorders
Depression
|
1.3%
1/79 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Ear infection viral
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.5%
1/40 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/79 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/40 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
0.00%
0/41 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
|
2.4%
1/41 • Number of events 1 • Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).
"# affected" for each tx group is the incidence count for each event occurring from Day 1-42. Day 8 Re-randomization per response to Wk 1 tx \& original tx assignment creates a higher exposure to LFMS Sham in Week 2. The "# at risk" for each tx group is total number of unique subjects who received at least one dose of tx being summarized during either Wk 1 or Wk 2.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place