Trial Outcomes & Findings for A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis (NCT NCT05692154)

NCT ID: NCT05692154

Last Updated: 2025-09-09

Results Overview

TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[0-6 hr\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 95 participants
• Primary outcome timeframe: From 0 hour to 6 hours at Day 4
• Results posted on: 2025-09-09

Participant Flow

A total of 95 participants took part in the study at one investigative site in Canada from 23 January 2023 to 14 March 2023.

Participants suffering from seasonal allergic rhinitis were randomly assigned in a 1:1 ratio to two arm groups Fexofenadine Pre-Treatment and Placebo Pre-Treatment.

Participant milestones

Measure	Arm A (Active-active) Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
Overall Study STARTED	47	48
Overall Study Intent To Treat (ITT) Analysis Set	47	48
Overall Study Safety Analysis (SAF) Set	47	47
Overall Study Modified Intent-to-Treat (mITT) Analysis Set	47	47
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Arm A (Active-active) Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
Overall Study Adverse Event	0	1

Baseline Characteristics

A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Total n=94 Participants Total of all reporting groups
Age, Continuous	47.0 years STANDARD_DEVIATION 12.82 • n=5 Participants	44.7 years STANDARD_DEVIATION 13.05 • n=7 Participants	45.9 years STANDARD_DEVIATION 12.92 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants	46 Participants n=7 Participants	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	45 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From 0 hour to 6 hours at Day 4

Population: The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4.

TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [0-6 hr]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3)	16.96 Sum of scores*hours Standard Deviation 9.090	21.42 Sum of scores*hours Standard Deviation 10.431

SECONDARY outcome

Timeframe: From 0 hour to 6 hours at Day 4

Population: The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4.

TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC [0-6 hr]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.6; Arm B=0.0-35.1.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4)	11.74 Sum of scores*hours Standard Deviation 10.451	16.21 Sum of scores*hours Standard Deviation 11.253

SECONDARY outcome

Timeframe: From 0 hour to 12 hours at Day 4

Population: The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4.

TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [0-12 hr]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-63.5; Arm B=2.1-69.4.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4)	23.66 Sum of scores*hours Standard Deviation 14.049	31.01 Sum of scores*hours Standard Deviation 18.555

SECONDARY outcome

Timeframe: From 0 hour to 12 hours at Day 4

Population: The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4.

TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC [0-12 hr]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-58.6; Arm B=0.0-65.5.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4)	14.74 Sum of scores*hours Standard Deviation 14.432	21.67 Sum of scores*hours Standard Deviation 17.154

SECONDARY outcome

Timeframe: From randomization (Day 1) to Day 4

Population: The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4.

TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3:scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [Day 1 to Day 4]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-267.8; Arm B=2.1-379.0.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4)	56.34 Sum of scores*hours Standard Deviation 55.697	65.48 Sum of scores*hours Standard Deviation 76.454

SECONDARY outcome

Timeframe: From randomization (Day 1) to Day 4

Population: The mITT analysis set contained all eligible, ITT, and treated participants with TNSS-3 evaluation at H0 at V4 and at least a further time point at Visit 4.

TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC [Day 1 to Day 4]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-226.6; Arm B=0.0-304.5.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
AUC of Total Ocular Symptoms Score (TOSS) (Day 1 to Day 4)	39.51 Sum of scores*hours Standard Deviation 55.416	47.21 Sum of scores*hours Standard Deviation 69.443

SECONDARY outcome

Timeframe: From Day 2 to Day 5

Population: The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.

An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A treatment emergent adverse event (TEAE) is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.

Outcome measures

Measure	Arm A (Active-active) n=47 Participants Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 Participants Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)	19.1 percentage of participants	12.8 percentage of participants

Adverse Events

Arm A (Active-active)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Arm B (Placebo-active)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm A (Active-active) n=47 participants at risk Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.	Arm B (Placebo-active) n=47 participants at risk Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4.
Ear and labyrinth disorders Tinnitus	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
General disorders Oedema mucosal	4.3% 2/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Immune system disorders Seasonal allergy	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Infections and infestations Gastroenteritis	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Injury, poisoning and procedural complications Skin abrasion	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Musculoskeletal and connective tissue disorders Back pain	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Musculoskeletal and connective tissue disorders Neck pain	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Nervous system disorders Headache	4.3% 2/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	4.3% 2/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Nervous system disorders Sinus headache	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	4.3% 2/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.
Respiratory, thoracic and mediastinal disorders Nasal oedema	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.	2.1% 1/47 • From Day 2 to Day 5 All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Analysis (SAF) Set. The SAF set contained all participants in the ITT set who received at least one dose of study drug and participants were classified according to treatment received.

Additional Information

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