Trial Outcomes & Findings for Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) (NCT NCT02709538)
NCT ID: NCT02709538
Last Updated: 2020-02-26
Results Overview
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
601 participants
Primary outcome timeframe
52 weeks
Results posted on
2020-02-26
Participant Flow
Participant milestones
| Measure |
GSP 301 NS
GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 3.7
GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 7.0
GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
400
|
100
|
101
|
|
Overall Study
COMPLETED
|
287
|
72
|
81
|
|
Overall Study
NOT COMPLETED
|
113
|
28
|
20
|
Reasons for withdrawal
| Measure |
GSP 301 NS
GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 3.7
GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 7.0
GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
24
|
8
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
40
|
7
|
4
|
|
Overall Study
Non-compliance with study procedures
|
5
|
0
|
0
|
|
Overall Study
Non-compliance with study drug
|
2
|
0
|
0
|
|
Overall Study
Protocol deviation
|
10
|
4
|
4
|
|
Overall Study
Withdrawal by Parent or Legal Guardian
|
1
|
0
|
0
|
|
Overall Study
Other
|
16
|
7
|
5
|
Baseline Characteristics
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
Baseline characteristics by cohort
| Measure |
GSP 301 NS
n=393 Participants
GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 3.7
n=99 Participants
GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 7.0
n=101 Participants
GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
269 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
405 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
95 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
282 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
436 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety Analysis Set (SAS) will consist of all subjects who took at least 1 dose of study medication following randomization. This was the primary analysis set for safety analyses.
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Outcome measures
| Measure |
GSP 301 NS
n=393 Participants
GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 3.7
n=99 Participants
GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 7.0
n=101 Participants
GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
|
203 participants
|
41 participants
|
54 participants
|
Adverse Events
GSP 301 NS
Serious events: 7 serious events
Other events: 72 other events
Deaths: 0 deaths
GSP 301 Placebo NS pH 3.7
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
GSP 301 Placebo NS pH 7.0
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSP 301 NS
n=393 participants at risk
GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 3.7
n=99 participants at risk
GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 7.0
n=101 participants at risk
GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.99%
1/101 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/393 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
1.0%
1/99 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Infections and infestations
Cellulitis
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/393 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
1.0%
1/99 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/393 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.99%
1/101 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.25%
1/393 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/99 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
0.00%
0/101 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
Other adverse events
| Measure |
GSP 301 NS
n=393 participants at risk
GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 3.7
n=99 participants at risk
GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks
|
GSP 301 Placebo NS pH 7.0
n=101 participants at risk
GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.1%
12/393 • Number of events 14 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
5.1%
5/99 • Number of events 6 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
5.9%
6/101 • Number of events 6 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
25/393 • Number of events 30 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
6.1%
6/99 • Number of events 8 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
8.9%
9/101 • Number of events 12 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Nervous system disorders
Headache
|
4.1%
16/393 • Number of events 18 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
3.0%
3/99 • Number of events 3 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
5.0%
5/101 • Number of events 5 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.6%
18/393 • Number of events 23 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
2.0%
2/99 • Number of events 2 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
2.0%
2/101 • Number of events 3 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.8%
11/393 • Number of events 15 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
2.0%
2/99 • Number of events 2 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
5.0%
5/101 • Number of events 7 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER