Trial Outcomes & Findings for Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction (NCT NCT05445921)
NCT ID: NCT05445921
Last Updated: 2023-11-07
Results Overview
Participants will be asked about their change in olfactory dysfunction on a 7-point Likert scale from much better to much worse.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
5-10 days post SGB #1 and 1 month
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Stellate Ganglion Block
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction
Baseline characteristics by cohort
| Measure |
Stellate Ganglion Block
n=20 Participants
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5-10 days post SGB #1 and 1 monthParticipants will be asked about their change in olfactory dysfunction on a 7-point Likert scale from much better to much worse.
Outcome measures
| Measure |
Stellate Ganglion Block
n=20 Participants
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Week · About the Same
|
12 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Week · Slightly Better
|
8 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Week · Moderately Better
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Week · Moderately Better
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Week · Much Better
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Month · About the Same
|
11 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Week · Slightly Better
|
4 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Week · Moderately Better
|
1 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Week · Much Better
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Week · Slightly Better
|
6 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Week · Moderately Better
|
1 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Week · Much Better
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Week · Much Better
|
0 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Month · About the Same
|
10 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Month · Slightly Better
|
6 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Month · Moderately Better
|
3 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Loss at 1 Month · Much Better
|
1 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Week · About the Same
|
11 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Week · Slightly Better
|
9 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Month · Slightly Better
|
6 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Month · Moderately Better
|
2 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Smell Distortion at 1 Month · Much Better
|
1 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Week · About the Same
|
15 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Month · About the Same
|
14 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Month · Slightly Better
|
3 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Month · Moderately Better
|
2 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Loss at 1 Month · Much Better
|
1 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Week · About the Same
|
13 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Month · About the Same
|
12 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Month · Slightly Better
|
5 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Month · Moderately Better
|
2 Participants
|
|
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I for Taste Distortion at 1 Month · Much Better
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline, 5-10 days, and 1 monthParticipants will complete the 40-item scratch and sniff UPSIT and mean change will be assessed. The UPSIT has a minimum score of 0 and maximum score of 40 with lower scores indicating a greater degree of impairment. An UPSIT score of \>33 for men and \>34 for women is considered normosmic, and the minimal clinically important difference is a change of 4 points.
Outcome measures
| Measure |
Stellate Ganglion Block
n=20 Participants
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
University of Pennsylvania Smell Identification Test (UPSIT)
UPSIT at Baseline
|
16.5 units on a scale
Interval 4.0 to 32.0
|
|
University of Pennsylvania Smell Identification Test (UPSIT)
UPSIT at 1 Week
|
21 units on a scale
Interval 10.0 to 31.0
|
|
University of Pennsylvania Smell Identification Test (UPSIT)
UPSIT at 1 Month
|
22.5 units on a scale
Interval 10.0 to 35.0
|
SECONDARY outcome
Timeframe: baseline, 5-10 days post SGB #1, and 1 monthParticipants will be asked to complete the ODOR, which is a patient-reported outcome measure assessing physical problems, functional limitations, and emotional consequences of olfactory dysfunction. The ODOR has a minimum score of 0 and a maximum score of 112 with higher scores indicating a greater degree of impairment and limitation. The minimal clinically important difference is a change of 15 points.
Outcome measures
| Measure |
Stellate Ganglion Block
n=20 Participants
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
Olfactory Dysfunction Outcomes Rating (ODOR)
ODOR at 1 Week
|
57 score on a scale
Interval 13.0 to 82.0
|
|
Olfactory Dysfunction Outcomes Rating (ODOR)
ODOR at Baseline
|
62 score on a scale
Interval 16.0 to 85.0
|
|
Olfactory Dysfunction Outcomes Rating (ODOR)
ODOR at 1 Month
|
50.5 score on a scale
Interval 2.0 to 75.0
|
SECONDARY outcome
Timeframe: baseline, 5-10 days, and 1 monthParticipants will be asked about the severity of their olfactory dysfunction (and gustatory dysfunction) on a 5-point Likert scale from no smell loss to severe smell loss.
Outcome measures
| Measure |
Stellate Ganglion Block
n=20 Participants
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at Baseline · Very Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at Baseline · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at Baseline · Moderate Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Week · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Week · Moderate Problem
|
8 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Month · No Problem
|
3 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Month · Very Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at Baseline · Severe Problem
|
11 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Week · No Problem
|
0 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Week · Very Mild Problem
|
4 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Week · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Week · Moderate Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Week · Severe Problem
|
9 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Month · No Problem
|
0 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Month · Very Mild Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Month · Severe Problem
|
6 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at Baseline · No Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at Baseline · No Problem
|
0 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at Baseline · Severe Problem
|
12 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Week · No Problem
|
0 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Week · Very Mild Problem
|
3 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Week · Severe Problem
|
7 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Month · No Problem
|
0 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Month · Very Mild Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Month · Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Month · Moderate Problem
|
9 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Loss at 1 Month · Severe Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at Baseline · No Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at Baseline · Very Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at Baseline · Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at Baseline · Moderate Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at Baseline · Severe Problem
|
12 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Week · No Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Week · Very Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Week · Mild Problem
|
4 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Week · Moderate Problem
|
4 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Week · Severe Problem
|
10 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Month · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Month · Moderate Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Smell Distortion at 1 Month · Severe Problem
|
9 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at Baseline · No Problem
|
0 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at Baseline · Very Mild Problem
|
3 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at Baseline · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at Baseline · Moderate Problem
|
4 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Month · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Loss at 1 Month · Moderate Problem
|
7 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at Baseline · Very Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at Baseline · Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at Baseline · Moderate Problem
|
3 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at Baseline · Severe Problem
|
12 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Week · No Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Week · Very Mild Problem
|
3 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Week · Mild Problem
|
1 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Week · Moderate Problem
|
5 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Week · Severe Problem
|
9 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Month · No Problem
|
3 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Month · Very Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Month · Mild Problem
|
2 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Month · Moderate Problem
|
6 Participants
|
|
Clinical Global Impression - Severity (CGI-S) Score
CGI-S for Taste Distortion at 1 Month · Severe Problem
|
7 Participants
|
Adverse Events
Stellate Ganglion Block
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stellate Ganglion Block
n=20 participants at risk
The ultrasound guided stellate ganglion blocks will be performed by a pain management specialist with extensive experience performing these blocks. The first SGB at the initial visit will be performed on the right side, and the second SGB will be on the left side 5-10 days after the first SGB, given that the patient tolerated the first SGB.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after a test does of 1% lidocaine, 1% mepivacaine will be injected near the stellate ganglion.
|
|---|---|
|
Nervous system disorders
Horner syndrome
|
100.0%
20/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
Nervous system disorders
Hoarseness
|
45.0%
9/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
Nervous system disorders
Globus
|
35.0%
7/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
Cardiac disorders
Brief lightheadedness
|
25.0%
5/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
Nervous system disorders
Numbness of the face
|
20.0%
4/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Mild shortness of breath
|
20.0%
4/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Nasal congestion
|
15.0%
3/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Pain at the injection site
|
15.0%
3/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Fatigue
|
15.0%
3/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Cough
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
Nervous system disorders
Weakness of the arm
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Weakness of the neck/back
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Tightness of the back
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Arm heaviness
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Bruising of the injection site
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Chest heaviness
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Headache
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Palpitations
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
|
General disorders
Tightness of the shoulder
|
5.0%
1/20 • 5 weeks
Adverse events were reported per injection. Since all participants received two injections, there were a total of 40 possible reported events for each particular adverse event.
|
Additional Information
Dr. Andrew Peterson, Resident Physician
Washington University School of Medicine, Dept. of Otolaryngology - Head and Neck Surgery
Phone: 314-362-5626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place