Trial Outcomes & Findings for Posterior Nasal Nerve (PNN) Rhinitis Study (NCT NCT03727347)
NCT ID: NCT03727347
Last Updated: 2021-06-16
Results Overview
Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value. The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in the rTNSS total score from Baseline to 12 week follow up visit
COMPLETED
NA
50 participants
Comparison of scores at Baseline and 12 weeks post procedure
2021-06-16
Participant Flow
Patients in the specialist's clinic seeking treatment for chronic rhinitis symptoms of at least 6 months duration were approached for possible participation. Following completion of the informed consent process, baseline evaluation was conducted.
Three potential subjects failed to meet one or more of the inclusion/exclusion criteria.
Participant milestones
| Measure |
InSeca Stylus
Low power radiofrequency treatment of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
2-week Evaluation
|
50
|
|
Overall Study
4-week Evaluation
|
50
|
|
Overall Study
12-week Primary Endpoint Evaluation
|
50
|
|
Overall Study
26-week Evaluation
|
48
|
|
Overall Study
52-week Evaluation
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
InSeca Stylus
Low power radiofrequency treatment of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Posterior Nasal Nerve (PNN) Rhinitis Study
Baseline characteristics by cohort
| Measure |
InSeca Stylus Treatment Group
n=50 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
|
Body Mass Index
|
29.8 kg/m2
STANDARD_DEVIATION 6.4 • n=99 Participants
|
|
rTNSS
|
8.5 score on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
|
PRIMARY outcome
Timeframe: Comparison of scores at Baseline and 12 weeks post procedurePopulation: The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight.
Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value. The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in the rTNSS total score from Baseline to 12 week follow up visit
Outcome measures
| Measure |
InSeca Stylus Treatment Group
n=49 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
Treatment Group - 2 Week Data
Data collected at 2 weeks post-study procedure
|
Treatment Group - 4 Week Data
Data collected at 4 weeks post-study procedure
|
Treatment Group - 12 Week Data
Data collected at 12 weeks post-study procedure
|
Treatment Group - 26 Week Data
Data collected at 26 weeks post-study procedure
|
Treatment Group - 52 Week Data
Data collected at 52 weeks post-study procedure
|
|---|---|---|---|---|---|---|
|
Change in Reflective Total Nasal Symptom Score (rTNSS)
|
-5.1 units on a scale
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At or following the study procedure, and up to the final study visit at 1 year.Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure.
Outcome measures
| Measure |
InSeca Stylus Treatment Group
n=50 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
Treatment Group - 2 Week Data
Data collected at 2 weeks post-study procedure
|
Treatment Group - 4 Week Data
Data collected at 4 weeks post-study procedure
|
Treatment Group - 12 Week Data
Data collected at 12 weeks post-study procedure
|
Treatment Group - 26 Week Data
Data collected at 26 weeks post-study procedure
|
Treatment Group - 52 Week Data
Data collected at 52 weeks post-study procedure
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment Related Adverse Events (Safety)
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Comparison of scores at Baseline and 12 weeks post procedurePopulation: The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight.
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. Subjects who showed at least a 1 point improvement (decrease) in the reflective Total Nasal Symptom Score (rTNSS) were categorized as responders. An overall responder rate of at least 55% was expected.
Outcome measures
| Measure |
InSeca Stylus Treatment Group
n=49 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
Treatment Group - 2 Week Data
Data collected at 2 weeks post-study procedure
|
Treatment Group - 4 Week Data
Data collected at 4 weeks post-study procedure
|
Treatment Group - 12 Week Data
Data collected at 12 weeks post-study procedure
|
Treatment Group - 26 Week Data
Data collected at 26 weeks post-study procedure
|
Treatment Group - 52 Week Data
Data collected at 52 weeks post-study procedure
|
|---|---|---|---|---|---|---|
|
rTNSS Responder Rate
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure.Population: 50 subjects were enrolled. 2 week evaluation: 1 subject missed it due to unrelated illness. 4 week evaluation: 1 subject missed it due to travel; 1 other attended the visit but did not complete the questionnaire. 12 week evaluation: All subjects attended but 1 subject did not complete the questionnaire. 26 week evaluation: 2 subjects withdrew from the study prior to the visit. 52 week evaluation: 1 additional subject was lost to follow-up.
Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores range from 0 to 12. A higher score indicates increased symptom severity. The mean change in the rTNSS total score from Baseline to each follow up visit: 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure will be recorded.
Outcome measures
| Measure |
InSeca Stylus Treatment Group
n=50 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
Treatment Group - 2 Week Data
n=49 Participants
Data collected at 2 weeks post-study procedure
|
Treatment Group - 4 Week Data
n=48 Participants
Data collected at 4 weeks post-study procedure
|
Treatment Group - 12 Week Data
n=49 Participants
Data collected at 12 weeks post-study procedure
|
Treatment Group - 26 Week Data
n=48 Participants
Data collected at 26 weeks post-study procedure
|
Treatment Group - 52 Week Data
n=47 Participants
Data collected at 52 weeks post-study procedure
|
|---|---|---|---|---|---|---|
|
Change in rTNSS Over Time
|
8.5 score on a scale
Standard Deviation 1.8
|
4.8 score on a scale
Standard Deviation 2.4
|
3.6 score on a scale
Standard Deviation 2.1
|
3.4 score on a scale
Standard Deviation 2.3
|
3.3 score on a scale
Standard Deviation 2.1
|
3.6 score on a scale
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedureReflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. Scores from each of the four components of the questionnaire (rhinorrhea, nasal congestion, nasal itching, and sneezing) will be evaluated at each follow up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. Individual component scores can range from 0 to 3, with a higher score indicating increased symptom severity.
Outcome measures
| Measure |
InSeca Stylus Treatment Group
n=50 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
Treatment Group - 2 Week Data
n=49 Participants
Data collected at 2 weeks post-study procedure
|
Treatment Group - 4 Week Data
n=48 Participants
Data collected at 4 weeks post-study procedure
|
Treatment Group - 12 Week Data
n=49 Participants
Data collected at 12 weeks post-study procedure
|
Treatment Group - 26 Week Data
n=48 Participants
Data collected at 26 weeks post-study procedure
|
Treatment Group - 52 Week Data
n=47 Participants
Data collected at 52 weeks post-study procedure
|
|---|---|---|---|---|---|---|
|
Change in rTNSS Individual Nasal Symptom Component Scores Over Time
Rhinorrhea
|
2.5 score on a scale
Standard Deviation 0.5
|
1.6 score on a scale
Standard Deviation 0.9
|
1.2 score on a scale
Standard Deviation 0.8
|
1.0 score on a scale
Standard Deviation 0.7
|
0.9 score on a scale
Standard Deviation 0.8
|
1.1 score on a scale
Standard Deviation 0.8
|
|
Change in rTNSS Individual Nasal Symptom Component Scores Over Time
Nasal Congestion
|
2.5 score on a scale
Standard Deviation 0.6
|
1.5 score on a scale
Standard Deviation 1.0
|
1.1 score on a scale
Standard Deviation 0.8
|
1.1 score on a scale
Standard Deviation 0.8
|
1.1 score on a scale
Standard Deviation 0.8
|
1.2 score on a scale
Standard Deviation 1.0
|
|
Change in rTNSS Individual Nasal Symptom Component Scores Over Time
Nasal Itching
|
1.7 score on a scale
Standard Deviation 0.9
|
0.7 score on a scale
Standard Deviation 0.8
|
0.4 score on a scale
Standard Deviation 0.6
|
0.5 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 0.7
|
|
Change in rTNSS Individual Nasal Symptom Component Scores Over Time
Sneezing
|
1.9 score on a scale
Standard Deviation 0.8
|
1.0 score on a scale
Standard Deviation 0.7
|
0.8 score on a scale
Standard Deviation 0.6
|
0.9 score on a scale
Standard Deviation 0.8
|
0.8 score on a scale
Standard Deviation 0.7
|
0.8 score on a scale
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The QOL was to be completed by the subject at baseline prior to the treatment procedure, and at the 12 week, 26 week and 52 week visits post procedure.Population: The baseline QOL was not completed by 4 subjects enrolled in the study. 12 week evaluation: 2 subjects failed to complete the QOL. 26 week evaluation: 2 subjects withdrew from the study prior to the 26 week visit. 52 week evaluation: 1 additional subject was lost to follow-up at this visit.
This Quality-of-Life (QOL) instrument is a 9-item patient self-reported questionnaire developed by Aerin Medical to gain understanding of the impact of chronic rhinitis on daily activities, feelings, symptoms and medication use. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. Section 1 asks "Please indicate how often you experience the following" for 6 items. For items 1, 3, 4 and 5, those who answered "never/rarely" were considered to have a positive (favorable) response. For questions 2 and 6, those who answered "frequently/very frequently" were considered to have a positive (favorable) response. Section 2 requests "Please indicate how often you use each of the following products to help you with your chronic rhinitis". For 3 items in this section, those who answered "never/rarely" were considered to have a positive (favorable) response.
Outcome measures
| Measure |
InSeca Stylus Treatment Group
n=46 Participants
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
Treatment Group - 2 Week Data
n=48 Participants
Data collected at 2 weeks post-study procedure
|
Treatment Group - 4 Week Data
n=48 Participants
Data collected at 4 weeks post-study procedure
|
Treatment Group - 12 Week Data
n=47 Participants
Data collected at 12 weeks post-study procedure
|
Treatment Group - 26 Week Data
Data collected at 26 weeks post-study procedure
|
Treatment Group - 52 Week Data
Data collected at 52 weeks post-study procedure
|
|---|---|---|---|---|---|---|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 1: Difficulty falling asleep · Positive (favorable) response
|
5 Participants
|
23 Participants
|
26 Participants
|
28 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 1: Difficulty falling asleep · Neutral or Negative response
|
41 Participants
|
25 Participants
|
22 Participants
|
19 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 2: Good sleep throughout the night · Positive (favorable) response
|
11 Participants
|
28 Participants
|
28 Participants
|
22 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 2: Good sleep throughout the night · Neutral or Negative response
|
35 Participants
|
20 Participants
|
20 Participants
|
25 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 3: Feeling fatigued during the day · Positive (favorable) response
|
3 Participants
|
17 Participants
|
14 Participants
|
14 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 3: Feeling fatigued during the day · Neutral or Negative response
|
43 Participants
|
31 Participants
|
34 Participants
|
33 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 4: Feelings of frustration/restlessness/irritability · Positive (favorable) response
|
7 Participants
|
30 Participants
|
26 Participants
|
29 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 4: Feelings of frustration/restlessness/irritability · Neutral or Negative response
|
39 Participants
|
18 Participants
|
22 Participants
|
18 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 5: Feelings of embarrassment or self-consciousness · Positive (favorable) response
|
10 Participants
|
38 Participants
|
31 Participants
|
33 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 2, Item 1: Oral medications · Positive (favorable) response
|
10 Participants
|
20 Participants
|
17 Participants
|
19 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 2, Item 1: Oral medications · Neutral or Negative response
|
36 Participants
|
28 Participants
|
31 Participants
|
28 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 2, Item 2: Nasal sprays · Positive (favorable) response
|
9 Participants
|
24 Participants
|
26 Participants
|
20 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 2, Item 2: Nasal sprays · Neutral or Negative response
|
37 Participants
|
24 Participants
|
22 Participants
|
27 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 2, Item 3: Nasal breathing strips · Positive (favorable) response
|
41 Participants
|
45 Participants
|
46 Participants
|
45 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 2, Item 3: Nasal breathing strips · Neutral or Negative response
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 5: Feelings of embarrassment or self-consciousness · Neutral or Negative response
|
36 Participants
|
10 Participants
|
17 Participants
|
14 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 6: Having a good sense of overall well-being · Positive (favorable) response
|
24 Participants
|
36 Participants
|
38 Participants
|
40 Participants
|
—
|
—
|
|
Response on Aerin Quality-of-Life (QOL) Assessment Items
Section 1, Item 6: Having a good sense of overall well-being · Neutral or Negative response
|
22 Participants
|
12 Participants
|
10 Participants
|
7 Participants
|
—
|
—
|
Adverse Events
InSeca Stylus Treatment Group
Serious adverse events
| Measure |
InSeca Stylus Treatment Group
n=50 participants at risk
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/50 • Number of events 1 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Gastrointestinal disorders
acute cholecystitis
|
2.0%
1/50 • Number of events 1 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
Other adverse events
| Measure |
InSeca Stylus Treatment Group
n=50 participants at risk
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.0%
3/50 • Number of events 3 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Infections and infestations
Bronchitis
|
6.0%
3/50 • Number of events 3 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Infections and infestations
Sinusitis
|
24.0%
12/50 • Number of events 12 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Infections and infestations
Upper respiratory tract infection/common cold
|
16.0%
8/50 • Number of events 8 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
3/50 • Number of events 3 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosa changes
|
4.0%
2/50 • Number of events 2 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal bleeding
|
4.0%
2/50 • Number of events 2 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
2/50 • Number of events 2 • From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.
- Publication restrictions are in place
Restriction type: OTHER