Trial Outcomes & Findings for An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo (NCT NCT01439815)
NCT ID: NCT01439815
Last Updated: 2021-04-14
Results Overview
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Results posted on
2021-04-14
Participant Flow
Subjects were recruited from one site in the US.
Twenty-two participants enrolled and completed the study. Participant flow and baseline characteristics are presented for the 22 subjects that met all inclusion criteria, none of the exclusion criteria and were randomized to receive Fluticasone Propionate or Placebo nasal spray twice daily based on the randomization list.
Participant milestones
| Measure |
Fluticasone Propionate Nasal Spray
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
All Randomized Participant Population
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16Population: All Randomized Participants Population - All participants who received study treatment
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed.
Outcome measures
| Measure |
Fluticasone Propionate Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
|---|---|---|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
pre-ABC
|
-0.7 units on a scale
Standard Deviation 1.8
|
0.3 units on a scale
Standard Deviation 1.8
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
15 minutes
|
-2.8 units on a scale
Standard Deviation 3.4
|
0.9 units on a scale
Standard Deviation 3.8
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
30 minutes
|
-4.1 units on a scale
Standard Deviation 3.4
|
-0.6 units on a scale
Standard Deviation 3.0
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
45 minutes
|
-3.9 units on a scale
Standard Deviation 4.2
|
-0.3 units on a scale
Standard Deviation 3.1
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
60 minutes
|
-4.7 units on a scale
Standard Deviation 3.6
|
-0.9 units on a scale
Standard Deviation 3.3
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
75 minutes
|
-4.5 units on a scale
Standard Deviation 4.5
|
-2.3 units on a scale
Standard Deviation 3.7
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
90 minutes
|
-4.5 units on a scale
Standard Deviation 4.3
|
-1.7 units on a scale
Standard Deviation 3.3
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
105 minutes
|
-5.0 units on a scale
Standard Deviation 4.0
|
-1.6 units on a scale
Standard Deviation 2.5
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
120 minutes
|
-5.9 units on a scale
Standard Deviation 3.1
|
-0.7 units on a scale
Standard Deviation 3.5
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
135 minutes
|
-4.8 units on a scale
Standard Deviation 4.0
|
-0.5 units on a scale
Standard Deviation 3.2
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
150 minutes
|
-5.3 units on a scale
Standard Deviation 3.6
|
-1.7 units on a scale
Standard Deviation 2.6
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
165 minutes
|
-5.4 units on a scale
Standard Deviation 3.2
|
-1.6 units on a scale
Standard Deviation 2.8
|
|
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
180 minutes
|
-5.9 units on a scale
Standard Deviation 3.0
|
-0.6 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16Nasal Itching was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal itching score between Day 0 and Day 16 was analyzed.
Outcome measures
| Measure |
Fluticasone Propionate Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
|---|---|---|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
Pre-ABC
|
-0.2 units on a scale
Standard Deviation 0.6
|
0.1 units on a scale
Standard Deviation 0.7
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
15 minutes
|
-1 units on a scale
Standard Deviation 1
|
0.3 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
30 minutes
|
-1 units on a scale
Standard Deviation 1.2
|
-0.1 units on a scale
Standard Deviation 0.6
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
45 minutes
|
-0.8 units on a scale
Standard Deviation 1.6
|
-0.1 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
60 minutes
|
-1.3 units on a scale
Standard Deviation 1.3
|
-0.3 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
75 minutes
|
-1.3 units on a scale
Standard Deviation 1.5
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
90 minutes
|
-1 units on a scale
Standard Deviation 1.6
|
-0.6 units on a scale
Standard Deviation 0.7
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
105 minutes
|
-1.3 units on a scale
Standard Deviation 1.3
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
120 minutes
|
-1.5 units on a scale
Standard Deviation 1.1
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
135 minutes
|
-1.5 units on a scale
Standard Deviation 1.2
|
-0.3 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
150 minutes
|
-1.5 units on a scale
Standard Deviation 1.3
|
-0.2 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
165 minutes
|
-1.5 units on a scale
Standard Deviation 1.1
|
-0.2 units on a scale
Standard Deviation 1
|
|
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
180 minutes
|
-1.8 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16Sneezing was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average sneezing score between Day 0 and Day 16 was analyzed.
Outcome measures
| Measure |
Fluticasone Propionate Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
|---|---|---|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
Pre-ABC
|
-0.1 units on a scale
Standard Deviation 0.3
|
0.2 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
15 minutes
|
-0.5 units on a scale
Standard Deviation 1.1
|
0.1 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
30 minutes
|
-0.9 units on a scale
Standard Deviation 0.8
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
45 minutes
|
-0.9 units on a scale
Standard Deviation 1.1
|
0 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
60 minutes
|
-1.3 units on a scale
Standard Deviation 1.1
|
-0.2 units on a scale
Standard Deviation 1
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
75 minutes
|
-1.1 units on a scale
Standard Deviation 1.3
|
-0.6 units on a scale
Standard Deviation 1.3
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
90 minutes
|
-1.1 units on a scale
Standard Deviation 1.4
|
-0.3 units on a scale
Standard Deviation 1.2
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
105 minutes
|
-1.2 units on a scale
Standard Deviation 1.1
|
-0.4 units on a scale
Standard Deviation 1
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
120 minutes
|
-1.3 units on a scale
Standard Deviation 1.3
|
-0.1 units on a scale
Standard Deviation 1.1
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
135 minutes
|
-0.9 units on a scale
Standard Deviation 1.4
|
0 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
150 minutes
|
-0.8 units on a scale
Standard Deviation 1.3
|
-0.7 units on a scale
Standard Deviation 1
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
165 minutes
|
-1.1 units on a scale
Standard Deviation 0.9
|
-0.6 units on a scale
Standard Deviation 1
|
|
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
180 minutes
|
-1.2 units on a scale
Standard Deviation 0.8
|
-0.1 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16Rhinorrhea was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average rhinorrhea score between Day 0 and Day 16 was analyzed.
Outcome measures
| Measure |
Fluticasone Propionate Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
|---|---|---|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
Pre-ABC
|
-0.4 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0.5
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
15 minutes
|
-0.9 units on a scale
Standard Deviation 0.9
|
0.4 units on a scale
Standard Deviation 1.2
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
30 minutes
|
-1.5 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
45 minutes
|
-1.1 units on a scale
Standard Deviation 1.1
|
-0.2 units on a scale
Standard Deviation 1
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
60 minutes
|
-1.2 units on a scale
Standard Deviation 1
|
-0.1 units on a scale
Standard Deviation 1
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
75 minutes
|
-1.3 units on a scale
Standard Deviation 1.1
|
-0.7 units on a scale
Standard Deviation 1.3
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
90 minutes
|
-1.5 units on a scale
Standard Deviation 1
|
-0.5 units on a scale
Standard Deviation 1.1
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
105 minutes
|
-1.4 units on a scale
Standard Deviation 1.4
|
-0.5 units on a scale
Standard Deviation 1
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
120 minutes
|
-1.7 units on a scale
Standard Deviation 0.6
|
-0.1 units on a scale
Standard Deviation 1
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
135 minutes
|
-1.4 units on a scale
Standard Deviation 1.1
|
0 units on a scale
Standard Deviation 1.1
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
150 minutes
|
-1.5 units on a scale
Standard Deviation 0.8
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
165 minutes
|
-1.4 units on a scale
Standard Deviation 0.8
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
180 minutes
|
-1.5 units on a scale
Standard Deviation 0.9
|
-0.3 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16Nasal Congestion was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal congestion score between Day 0 and Day 16 was analyzed.
Outcome measures
| Measure |
Fluticasone Propionate Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
Placebo Nasal Spray
n=11 Participants
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
|
|---|---|---|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
Pre-ABC
|
-0.1 units on a scale
Standard Deviation 1
|
0 units on a scale
Standard Deviation 0.7
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
15 minutes
|
-0.4 units on a scale
Standard Deviation 1.2
|
0.1 units on a scale
Standard Deviation 1.3
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
30 minutes
|
-0.7 units on a scale
Standard Deviation 1.3
|
-0.1 units on a scale
Standard Deviation 1.2
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
45 minutes
|
-1.1 units on a scale
Standard Deviation 1.1
|
0 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
60 minutes
|
-1 units on a scale
Standard Deviation 1.1
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
75 minutes
|
-0.9 units on a scale
Standard Deviation 1.1
|
-0.5 units on a scale
Standard Deviation 1
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
90 minutes
|
-1.1 units on a scale
Standard Deviation 1.2
|
-0.3 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
105 minutes
|
-1.2 units on a scale
Standard Deviation 1
|
-0.2 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
120 minutes
|
-1.5 units on a scale
Standard Deviation 0.9
|
-0.2 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
135 minutes
|
-1.1 units on a scale
Standard Deviation 1.1
|
-0.2 units on a scale
Standard Deviation 0.9
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
150 minutes
|
-1.4 units on a scale
Standard Deviation 0.9
|
-0.3 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
165 minutes
|
-1.4 units on a scale
Standard Deviation 0.9
|
-0.3 units on a scale
Standard Deviation 0.8
|
|
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
180 minutes
|
-1.5 units on a scale
Standard Deviation 0.9
|
-0.1 units on a scale
Standard Deviation 0.9
|
Adverse Events
Fluticasone Propionate Nasal Spray
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Nasal Spray
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluticasone Propionate Nasal Spray
n=11 participants at risk
Two sprays in each nostril daily starting the day after Day 1 for up to 14 days.
|
Placebo Nasal Spray
n=11 participants at risk
Two sprays in each nostril daily starting the day after Day 1 for up to 14 days.
|
|---|---|---|
|
General disorders
hives (neck)
|
0.00%
0/11 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
|
General disorders
dizziness
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
0.00%
0/11 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
|
General disorders
headache
|
0.00%
0/11 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
|
General disorders
hives (face)
|
0.00%
0/11 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline (Day 0) through study completion (Day 16). All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place