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Oral Immunotherapy for Childhood Egg Allergy

This study has been completed.
Sponsor:
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00461097
First received: April 16, 2007
Last updated: December 24, 2013
Last verified: December 2013
Results First Received: December 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Hypersensitivity
Immediate Hypersensitivity
Food Hypersensitivity
Interventions: Drug: Egg oral immunotherapy
Drug: Control Group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital) from July 2007 to December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Egg Oral Immunotherapy (OIT) Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
Placebo Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.

Participant Flow:   Overall Study
    Egg Oral Immunotherapy (OIT)     Placebo  
STARTED     40     15  
Had Month 10 (Wk 44) Oral Food Challenge     35     13  
Had Month 22 (Wk 96) Oral Food Challenge     34     1  
Had Year 3 (Mnth 36) Oral Food Challenge     16     0  
Had Year 4 (Mnth 48) Oral Food Challenge     7     0  
COMPLETED     40 [1]   15 [2]
NOT COMPLETED     0     0  
[1] Completed: Participants who were assessed for the primary outcome measure and outcome measure #6.
[2] Completed: Participants who were assessed for the primary outcome measure.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Egg Oral Immunotherapy (OIT) Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
Placebo Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
Total Total of all reporting groups

Baseline Measures
    Egg Oral Immunotherapy (OIT)     Placebo     Total  
Number of Participants  
[units: participants]
  40     15     55  
Age  
[units: participants]
     
<=18 years     40     15     55  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.1  ± 1.6     7.1  ± 1.6     7.1  ± 1.6  
Gender  
[units: participants]
     
Female     15     6     21  
Male     25     9     34  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     38     14     52  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     5     0     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     34     14     48  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     40     15     55  
Atopic Dermatitis Total Score [1]
[units: Scores on a scale]
Mean ± Standard Deviation
  3.1  ± 2.5     3.0  ± 2.8     3.1  ± 2.5  
Total IgE [2]
[units: kU/L]
Mean ± Standard Deviation
  1378.7  ± 1728.6     1464.7  ± 1182.7     1402.1  ± 1588.1  
Egg IgE [3]
[units: kUA/L]
Mean ± Standard Deviation
  32.9  ± 54.7     32.1  ± 27.3     32.7  ± 48.5  
Egg Skin Prick Test Score [4]
[units: mm]
Mean ± Standard Deviation
  11.8  ± 5.7     12.8  ± 4.3     12.1  ± 5.4  
Age at Initial Egg Allergic Reaction  
[units: years]
Mean ± Standard Deviation
  2.3  ± 2.1     1.3  ± 1.4     2.0  ± 2.0  
[1] The Atopic Dermatitis Total Score is scored on a 10 point scale from 0 to 9 where a higher score indicates increased severity of atopic dermatitis. This score is a combination of 3 scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.
[2] Total amount of serum immunoglobulin E. Individuals who are not allergic may have a total IgE as high as 304 kU/L.
[3] Amount of serum egg-specific immunoglobulin E. Individuals with an egg IgE of <0.35 kUA/L are considered not to be sensitized to egg.
[4] This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the egg wheal (in mm) observed for a skin prick test. Individuals with an egg skin prick test score of < 3 mm are considered to have a negative result.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg   [ Time Frame: At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy ]

2.  Secondary:   Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid   [ Time Frame: Following the blinded desensitization phase at approximately Week 44 ]

3.  Secondary:   Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation   [ Time Frame: Initial day of dosing ]

4.  Secondary:   Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg   [ Time Frame: Following the blinded desensitization phase at approximately Week 44 ]

5.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: Baseline through the 2-year primary endpoint ]

6.  Secondary:   Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid   [ Time Frame: 4 years (48 months) ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
Additional Description This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Egg Oral Immunotherapy (OIT), 0-2 Years Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
Placebo, 0-2 Years Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
Egg Oral Immunotherapy (OIT), 2-4 Years

Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.

Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing).


Other Adverse Events
    Egg Oral Immunotherapy (OIT), 0-2 Years     Placebo, 0-2 Years     Egg Oral Immunotherapy (OIT), 2-4 Years  
Total, other (not including serious) adverse events        
# participants affected / at risk     40/40     15/15     26/36  
Ear and labyrinth disorders        
Middle ear effusion * 1      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     1     1     0  
Ear discomfort † 2      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     3     0     0  
Ear pruritus † 2      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/22 (0.00%)  
# events     10     0     0  
Eye disorders        
Conjunctivitis * 1      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     2/36 (5.56%)  
# events     3     1     2  
Conjunctivitis allergic * 1      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     2/36 (5.56%)  
# events     2     0     2  
Eye irritation † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     1     0  
Eye pruritus † 2      
# participants affected / at risk     5/40 (12.50%)     3/15 (20.00%)     1/22 (4.55%)  
# events     71     4     11  
Lacrimation increased † 2      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/22 (0.00%)  
# events     5     0     0  
Ocular hyperaemia † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     1     0  
Conjunctivitis † 2      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     2     0     0  
Gastrointestinal disorders        
Abdominal pain upper * 1      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     2/36 (5.56%)  
# events     5     2     2  
Diarrhoea * 1      
# participants affected / at risk     2/40 (5.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     3     1     0  
Nausea * 1      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     2/36 (5.56%)  
# events     1     1     4  
Vomiting * 1      
# participants affected / at risk     10/40 (25.00%)     2/15 (13.33%)     6/36 (16.67%)  
# events     15     2     8  
Abdominal discomfort † 2      
# participants affected / at risk     34/40 (85.00%)     4/15 (26.67%)     4/22 (18.18%)  
# events     807     9     20  
Abdominal pain † 2      
# participants affected / at risk     16/40 (40.00%)     2/15 (13.33%)     0/22 (0.00%)  
# events     28     2     0  
Diarrhoea † 2      
# participants affected / at risk     8/40 (20.00%)     0/15 (0.00%)     1/22 (4.55%)  
# events     20     0     1  
Dysphagia † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     1     0  
Gastrooesophageal reflux disease † 2      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     79     0     0  
Lip swelling † 2      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     1/22 (4.55%)  
# events     3     0     3  
Oral disorder † 2      
# participants affected / at risk     31/40 (77.50%)     3/15 (20.00%)     8/22 (36.36%)  
# events     2457     9     214  
Vomiting † 2      
# participants affected / at risk     28/40 (70.00%)     2/15 (13.33%)     4/22 (18.18%)  
# events     125     4     4  
Abdominal discomfort * 1      
# participants affected / at risk     0/40 (0.00%)     0/15 (0.00%)     2/36 (5.56%)  
# events     0     0     3  
Abdominal pain * 1      
# participants affected / at risk     1/40 (2.50%)     0/15 (0.00%)     2/36 (5.56%)  
# events     1     0     2  
Glossodynia † 2      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     3     0     0  
General disorders        
Chest discomfort * 1      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     3/36 (8.33%)  
# events     2     0     3  
Influenza like illness * 1      
# participants affected / at risk     4/40 (10.00%)     0/15 (0.00%)     0/36 (0.00%)  
# events     7     0     0  
Pyrexia * 1      
# participants affected / at risk     8/40 (20.00%)     1/15 (6.67%)     8/36 (22.22%)  
# events     11     1     16  
Chest discomfort † 2      
# participants affected / at risk     6/40 (15.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     8     0     0  
Chest pain † 2      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     0/22 (0.00%)  
# events     1     1     0  
Fatigue † 2      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/22 (0.00%)  
# events     6     0     0  
Feeling hot † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     1     0  
Immune system disorders        
Hypersensitivity * 1      
# participants affected / at risk     4/40 (10.00%)     0/15 (0.00%)     1/36 (2.78%)  
# events     7     0     1  
Seasonal allergy * 1      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/36 (0.00%)  
# events     2     0     0  
Infections and infestations        
Acute sinusitis * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     1     0  
Bronchitis * 1      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     3     1     0  
Cellulitis * 1      
# participants affected / at risk     0/40 (0.00%)     2/15 (13.33%)     0/36 (0.00%)  
# events     0     2     0  
Croup infectious * 1      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     1     1     0  
Febrile infection * 1      
# participants affected / at risk     4/40 (10.00%)     0/15 (0.00%)     0/36 (0.00%)  
# events     5     0     0  
Gastroenteritis * 1      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/36 (0.00%)  
# events     3     0     0  
Gastroenteritis viral * 1      
# participants affected / at risk     12/40 (30.00%)     3/15 (20.00%)     6/36 (16.67%)  
# events     17     3     6  
Impetigo * 1      
# participants affected / at risk     1/40 (2.50%)     3/15 (20.00%)     0/36 (0.00%)  
# events     1     4     0  
Influenza * 1      
# participants affected / at risk     11/40 (27.50%)     3/15 (20.00%)     4/36 (11.11%)  
# events     12     4     5  
Lobar pneumonia * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     1     0  
Molluscum contagiosum * 3      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     1/36 (2.78%)  
# events     1     1     1  
Nasopharyngitis * 1      
# participants affected / at risk     11/40 (27.50%)     5/15 (33.33%)     6/36 (16.67%)  
# events     32     12     11  
Otitis externa * 1      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     1     1     0  
Otitis media * 1      
# participants affected / at risk     4/40 (10.00%)     4/15 (26.67%)     5/36 (13.89%)  
# events     6     4     8  
Pharyngitis streptococcal * 1      
# participants affected / at risk     4/40 (10.00%)     1/15 (6.67%)     2/36 (5.56%)  
# events     11     1     2  
Pneumonia * 1      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     2/36 (5.56%)  
# events     4     0     2  
Sinusitis * 1      
# participants affected / at risk     8/40 (20.00%)     2/15 (13.33%)     5/36 (13.89%)  
# events     13     3     7  
Skin infection * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     2     0  
Subcutaneous abscess * 1      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     1     1     0  
Tonsillitis streptococcal * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     1     0  
Upper respiratory tract infection * 1      
# participants affected / at risk     20/40 (50.00%)     9/15 (60.00%)     10/36 (27.78%)  
# events     59     10     19  
Urinary tract infection * 1      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     1/36 (2.78%)  
# events     2     0     1  
Viral infection * 1      
# participants affected / at risk     5/40 (12.50%)     1/15 (6.67%)     1/36 (2.78%)  
# events     5     1     1  
Viral pharyngitis * 1      
# participants affected / at risk     4/40 (10.00%)     0/15 (0.00%)     0/36 (0.00%)  
# events     5     0     0  
Viral upper respiratory tract infection * 1      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     3     1     0  
Staphylococcal impetigo * 1      
# participants affected / at risk     0/40 (0.00%)     0/15 (0.00%)     2/36 (5.56%)  
# events     0     0     2  
Injury, poisoning and procedural complications        
Arthropod bite * 1      
# participants affected / at risk     1/40 (2.50%)     1/15 (6.67%)     0/36 (0.00%)  
# events     1     1     0  
Ligament sprain * 1      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/36 (0.00%)  
# events     3     0     0  
Nervous system disorders        
Headache * 1      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     4/36 (11.11%)  
# events     4     2     4  
Headache † 2      
# participants affected / at risk     3/40 (7.50%)     2/15 (13.33%)     1/22 (4.55%)  
# events     25     2     1  
Psychomotor hyperactivity † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     1     0  
Psychiatric disorders        
Nervousness † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     1     0  
Respiratory, thoracic and mediastinal disorders        
Allergic cough * 1      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     1/36 (2.78%)  
# events     3     0     2  
Asthma * 1      
# participants affected / at risk     6/40 (15.00%)     2/15 (13.33%)     6/36 (16.67%)  
# events     10     2     8  
Bronchial hyperreactivity * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     1     0  
Cough * 1      
# participants affected / at risk     13/40 (32.50%)     1/15 (6.67%)     4/36 (11.11%)  
# events     20     1     7  
Nasal congestion * 1      
# participants affected / at risk     6/40 (15.00%)     0/15 (0.00%)     1/36 (2.78%)  
# events     11     0     1  
Oropharyngeal pain * 1      
# participants affected / at risk     4/40 (10.00%)     0/15 (0.00%)     2/36 (5.56%)  
# events     4     0     2  
Wheezing * 1      
# participants affected / at risk     8/40 (20.00%)     1/15 (6.67%)     2/36 (5.56%)  
# events     17     1     5  
Cough † 2      
# participants affected / at risk     26/40 (65.00%)     5/15 (33.33%)     3/22 (13.64%)  
# events     182     35     5  
Dysphonia † 2      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     3     0     0  
Dyspnoea † 2      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/22 (0.00%)  
# events     3     0     0  
Hiccups † 2      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     0     2     0  
Nasal congestion † 2      
# participants affected / at risk     16/40 (40.00%)     5/15 (33.33%)     2/22 (9.09%)  
# events     385     27     151  
Nasal discomfort † 2      
# participants affected / at risk     3/40 (7.50%)     2/15 (13.33%)     0/22 (0.00%)  
# events     10     2     0  
Oropharyngeal discomfort † 2      
# participants affected / at risk     22/40 (55.00%)     1/15 (6.67%)     4/22 (18.18%)  
# events     658     1     36  
Sneezing † 2      
# participants affected / at risk     21/40 (52.50%)     6/15 (40.00%)     1/22 (4.55%)  
# events     72     54     1  
Throat irritation † 2      
# participants affected / at risk     4/40 (10.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     11     0     0  
Throat tightness † 2      
# participants affected / at risk     6/40 (15.00%)     1/15 (6.67%)     0/22 (0.00%)  
# events     11     1     0  
Wheezing † 2      
# participants affected / at risk     10/40 (25.00%)     0/15 (0.00%)     0/22 (0.00%)  
# events     42     0     0  
Nasal turbinate hypertrophy * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     1     0  
Rhinorrhoea * 1      
# participants affected / at risk     2/40 (5.00%)     0/15 (0.00%)     0/36 (0.00%)  
# events     2     0     0  
Skin and subcutaneous tissue disorders        
Dyshidrosis * 1      
# participants affected / at risk     0/40 (0.00%)     1/15 (6.67%)     0/36 (0.00%)  
# events     0     1     0  
Rash * 1      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/36 (0.00%)  
# events     4     0     0  
Eczema † 2      
# participants affected / at risk     3/40 (7.50%)     0/15 (0.00%)     0/22 (0.00%)  
# events     4     0     0  
Erythema † 2      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     0/22 (0.00%)  
# events     3     1     0  
Pruritus † 2      
# participants affected / at risk     28/40 (70.00%)     3/15 (20.00%)     4/22 (18.18%)  
# events     424     12     78  
Rash † 2      
# participants affected / at risk     4/40 (10.00%)     3/15 (20.00%)     0/22 (0.00%)  
# events     9     14     0  
Rash macular † 2      
# participants affected / at risk     3/40 (7.50%)     1/15 (6.67%)     0/22 (0.00%)  
# events     4     1     0  
Urticaria † 2      
# participants affected / at risk     27/40 (67.50%)     5/15 (33.33%)     5/22 (22.73%)  
# events     398     19     18  
Dermatitis allergic * 1      
# participants affected / at risk     1/40 (2.50%)     0/15 (0.00%)     2/36 (5.56%)  
# events     1     0     2  
Eczema * 1      
# participants affected / at risk     1/40 (2.50%)     0/15 (0.00%)     2/36 (5.56%)  
# events     1     0     5  
Vascular disorders        
Flushing † 2      
# participants affected / at risk     18/40 (45.00%)     3/15 (20.00%)     2/22 (9.09%)  
# events     43     3     2  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (15.0)
2 Term from vocabulary, MedDRA (14.1)
3 Term from vocabulary, MedDRA (15.1)



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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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