Trial Outcomes & Findings for Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness (NCT NCT03077919)
NCT ID: NCT03077919
Last Updated: 2020-05-13
Results Overview
≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD).
COMPLETED
NA
113 participants
Baseline, 8-weeks
2020-05-13
Participant Flow
123 participants screened eligible and completed the baseline CAPS-5
113 participants were randomized to treatment/sham and underwent the study procedure at Week 0 and Week 2.
Participant milestones
| Measure |
Stellate Ganglion Block (SGB)
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
39
|
|
Overall Study
Week 2 Visit
|
74
|
39
|
|
Overall Study
Week 4 Visit
|
73
|
38
|
|
Overall Study
Week 6 Visit
|
73
|
38
|
|
Overall Study
Week 8 Visit
|
71
|
38
|
|
Overall Study
Final CAPS
|
70
|
38
|
|
Overall Study
COMPLETED
|
70
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Stellate Ganglion Block (SGB)
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=74 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=113 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=74 Participants
|
39 Participants
n=39 Participants
|
113 Participants
n=113 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=74 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=113 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=74 Participants
|
3 Participants
n=39 Participants
|
13 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=74 Participants
|
36 Participants
n=39 Participants
|
100 Participants
n=113 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Marital Status
Married
|
67 Participants
n=74 Participants
|
33 Participants
n=39 Participants
|
100 Participants
n=113 Participants
|
|
Marital Status
Unmarried
|
7 Participants
n=74 Participants
|
6 Participants
n=39 Participants
|
13 Participants
n=113 Participants
|
|
Military Rank
Junior Enlisted
|
3 Participants
n=74 Participants
|
3 Participants
n=39 Participants
|
6 Participants
n=113 Participants
|
|
Military Rank
Non-commissioned Officer
|
27 Participants
n=74 Participants
|
11 Participants
n=39 Participants
|
38 Participants
n=113 Participants
|
|
Military Rank
Senior Enlisted
|
28 Participants
n=74 Participants
|
19 Participants
n=39 Participants
|
47 Participants
n=113 Participants
|
|
Military Rank
Warrant Officer
|
5 Participants
n=74 Participants
|
3 Participants
n=39 Participants
|
8 Participants
n=113 Participants
|
|
Military Rank
Commissioned Officer
|
11 Participants
n=74 Participants
|
3 Participants
n=39 Participants
|
14 Participants
n=113 Participants
|
|
Met CAPS-5 Criteria for PTSD
|
60 Participants
n=74 Participants
|
31 Participants
n=39 Participants
|
91 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8-weeksPopulation: Multiple imputation performed for missing data; Mean change - Adjusted for site and baseline CAPS TSSS; adjusted mean reduction in TSSS from baseline to week 8 by treatment group from per-protocol analysis and secondary analysis among those who fulfilled CAPS 5 diagnostic criteria for PTSD at baseline were consistent with those from ITT analyses
≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD).
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Clinician Administered PTSD Score (CAPS-5) TSSS
Baseline
|
37.61 score on a scale
Standard Deviation 11.13
|
39.82 score on a scale
Standard Deviation 14.23
|
|
Clinician Administered PTSD Score (CAPS-5) TSSS
8-week follow-up
|
25.67 score on a scale
Standard Deviation 14.13
|
33.68 score on a scale
Standard Deviation 15.60
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline; On the PCL 5, the range is 0 to 80, with higher scores indicating worse PTSD symptomatology.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
PTSD Checklist (PCL-5)
Baseline
|
41.54 score on a scale
Standard Deviation 14.03
|
43.23 score on a scale
Standard Deviation 18.13
|
|
PTSD Checklist (PCL-5)
8-week follow-up
|
29.49 score on a scale
Standard Deviation 19.29
|
38.11 score on a scale
Standard Deviation 18.23
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline; The total symptom severity score ranges from 17 to 85. The higher the score, the more severe the PTSD symptomatology
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
PTSD Checklist Civilian (PCL-C)
Baseline
|
53.30 score on a scale
Standard Deviation 13.64
|
54.95 score on a scale
Standard Deviation 15.67
|
|
PTSD Checklist Civilian (PCL-C)
8-week follow-up
|
42.41 score on a scale
Standard Deviation 17.47
|
50.65 score on a scale
Standard Deviation 17.04
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksto evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 8 weeks. The higher the score, the more severe the pathology. If an individual answers "yes" to any of seven initial questions concerning suicidal ideation in the past two months, they are asked an additional four questions regarding current suicidal ideation. Any positive answer on these four current questions triggers an automated alert system.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items
Baseline
|
0 number of events
Interval 0.0 to 3.0
|
0 number of events
Interval 0.0 to 3.0
|
|
Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items
8-week follow-up
|
0 number of events
Interval 0.0 to 3.0
|
0 number of events
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksto evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks. Based on a scale of 0 to 12, a score of 4 or greater is considered positive in males, while a score of 3 or more is positive among females.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C)
Baseline
|
2.74 score on a scale
Standard Deviation 2.64
|
3.18 score on a scale
Standard Deviation 4.26
|
|
Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C)
8-week follow-up
|
2.72 score on a scale
Standard Deviation 2.71
|
2.62 score on a scale
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Kessler Psychiatric Distress Scale (K6) at 8 weeks. Scores range from 0 to 24 resulting from 6 items administered on a scale of 0 to 4, with a score of 13 or greater indicative of serious psychological distress in the U.S. general population.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Kessler Psychiatric Distress Scale (K6)
Baseline
|
10.08 score on a scale
Standard Deviation 5.55
|
10.33 score on a scale
Standard Deviation 6.01
|
|
Kessler Psychiatric Distress Scale (K6)
8-week follow-up
|
7.80 score on a scale
Standard Deviation 6.41
|
10.00 score on a scale
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by The Patient Health Questionnaire (PHQ-9) at 8 weeks; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
The Patient Health Questionnaire (PHQ-9)
Baseline
|
12.57 score on a scale
Standard Deviation 6.05
|
12.69 score on a scale
Standard Deviation 6.61
|
|
The Patient Health Questionnaire (PHQ-9)
8-week follow-up
|
8.68 score on a scale
Standard Deviation 6.02
|
11.76 score on a scale
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at 8 weeks;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Generalized Anxiety Disorder 7-item Survey (GAD-7)
Baseline
|
12.39 score on a scale
Standard Deviation 5.35
|
12.49 score on a scale
Standard Deviation 5.50
|
|
Generalized Anxiety Disorder 7-item Survey (GAD-7)
8-week follow-up
|
8.11 score on a scale
Standard Deviation 6.02
|
11.19 score on a scale
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by 12-item Short Form Survey (SF-12) at 8 weeks. The score mean is 50; standard deviation of 10. The physical component score (PCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better physical health. The United States population average PCS-12 is 50 points.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
12-item Short Form Survey (SF-12) of Physical Functioning
Baseline
|
41.04 score on a scale
Standard Deviation 8.16
|
42.01 score on a scale
Standard Deviation 7.87
|
|
12-item Short Form Survey (SF-12) of Physical Functioning
8-week follow-up
|
43.43 score on a scale
Standard Deviation 8.33
|
41.28 score on a scale
Standard Deviation 8.18
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: \[\*\] Analysis Population Description Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Pain Scale at 8 weeks; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Short Pain Scale
Baseline
|
4.61 score on a scale
Standard Deviation 2.40
|
4.95 score on a scale
Standard Deviation 2.21
|
|
Short Pain Scale
8-week follow-up
|
4.10 score on a scale
Standard Deviation 2.51
|
4.86 score on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksto evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by a decrease in Current Medications at 8 weeks; in order to assess the potential impact of medication use concurrent with study participation, information on prescription psychotropics (including stimulants, anxiolytics, and antidepressants), anticonvulsants, antipsychotics, anticholinergic drugs, opioids, nicotine, sleeping medications, antihypertensives, and sympathomimetics/sympatholytics was collected.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Current Medications
Baseline
|
1 Medications
Interval 0.0 to 12.0
|
2 Medications
Interval 0.0 to 6.0
|
|
Current Medications
8-week follow-up
|
1 Medications
Interval 0.0 to 13.0
|
1 Medications
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 8-weeksPopulation: Adjusted for site, gender, age, visit, and interaction between visit and treatment.
to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Mental Functioning Scale at 8 weeks. The score mean is 50; standard deviation of 10. The mental component score (MCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better mental health. The United States population average MCS-12 is 50 points.
Outcome measures
| Measure |
Stellate Ganglion Block (SGB)
n=74 Participants
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 Participants
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
12 Item Short Form Survey (SF-12) of Mental Functioning
Baseline
|
41.24 score on a scale
Standard Deviation 11.32
|
40.16 score on a scale
Standard Deviation 9.84
|
|
12 Item Short Form Survey (SF-12) of Mental Functioning
8-week follow-up
|
42.83 score on a scale
Standard Deviation 10.22
|
40.17 score on a scale
Standard Deviation 9.50
|
Adverse Events
Stellate Ganglion Block (SGB)
Sham Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stellate Ganglion Block (SGB)
n=74 participants at risk
7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).
Ropivacaine: 0.5% ropivacaine
|
Sham Treatment
n=39 participants at risk
1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.
Sham treatment: preservative-free normal saline
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Temporary irritation of larynx which resulted in coughing
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected for eight weeks.
|
0.00%
0/39 • Adverse event data was collected for eight weeks.
|
|
Skin and subcutaneous tissue disorders
Pain and redness at injection site
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected for eight weeks.
|
0.00%
0/39 • Adverse event data was collected for eight weeks.
|
|
Nervous system disorders
Vasovagal syncope with insertion of the IV
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected for eight weeks.
|
0.00%
0/39 • Adverse event data was collected for eight weeks.
|
|
Endocrine disorders
Detection of nodule or cyst (< 1 cm) in thyroid gland
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected for eight weeks.
|
0.00%
0/39 • Adverse event data was collected for eight weeks.
|
|
Cardiac disorders
Self-resolving episode of bradycardia (30-second duration; minimum heart rate of 32)
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected for eight weeks.
|
0.00%
0/39 • Adverse event data was collected for eight weeks.
|
|
Nervous system disorders
Report of mild, relative increase in pre-existing right tinnitus
|
0.00%
0/74 • Adverse event data was collected for eight weeks.
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected for eight weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place