Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U19AI066738 | U.S. NIH Grant/Contract | View source | |
| CoFAR7 | Other Identifier | Consortium of Food Allergy Research |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Consortium of Food Allergy Research | OTHER |
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The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.
Food allergy affects 6-8 percent of children in the United States. In young children, reactions to egg can range from hives to severe life threatening allergic reactions called anaphylaxis. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The purpose of this study is to compare baked foods with egg versus (vs.) egg OIT. The intent of the study is to investigate if participants will be able to consume egg after taking baked foods with egg or egg OIT for a period of time and then stopping for a certain period. This is referred to as tolerance or sustained unresponsiveness. This study will evaluate the effectiveness of the egg OIT vs. baked egg by having each participant ingest egg white solid or baked foods with egg. This will be done over 2 years.
This study will last 2 years. All eligible subjects will receive a baked egg oral food challenge (OFC). Those who pass the baked egg OFC will then have a 2 gm egg OFC. Those who react to the egg OFC will be randomized to Baked Egg or Egg OIT. Individuals who do not pass the initial baked egg OFC will be assigned to Egg OIT. Those who pass the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1-year and a 2-year OFC.
At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg OIT Randomized | Experimental | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. |
|
| Baked Egg Randomized | Experimental | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol. |
|
| Egg OIT Assigned | Experimental | Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg Oral Immunotherapy | Drug | Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Unresponsiveness to Egg Consumption at 2 Years. | Sustained unresponsiveness - able to successfully consume 7444 mg egg white protein in a desensitization OFC and, after an 8-10 week egg-free interval, were also able to successfully consume 7444 mg egg white protein in an OFC after up to 2 years of therapy. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Desensitization to >= 4.444 Grams Egg White Solid. | Development of desensitization to able to successfully consume >=4444 mg egg white protein during a desensitization OFC on therapy at 1 year and 2 years. | 1 Year and 2 Years |
| Incidence of All Serious Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results. | Changes in egg-specific IgE and IgG4, changes in SPT mean wheal diameters, basophil reactivity, Th2 and Treg values. | 2 Years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh A Sampson, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Robert Wood, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| National Jewish Health |
Not provided
| Label | URL |
|---|---|
| Study Web Site | View source |
Not provided
Not provided
Study recruitment began in July 2013 and accrual closed in August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baked Egg Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol. Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions. |
| FG001 | Egg OIT Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| FG002 | Egg OIT Assigned | Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only treated participants are included in analysis
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Baked Egg Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol. Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Unresponsiveness to Egg Consumption at 2 Years. | Sustained unresponsiveness - able to successfully consume 7444 mg egg white protein in a desensitization OFC and, after an 8-10 week egg-free interval, were also able to successfully consume 7444 mg egg white protein in an OFC after up to 2 years of therapy. | All treated participants were included in the analysis. | Posted | Count of Participants | Participants | 2 Years |
|
up to 3 years, through last clinic visit.
* Unsolicited - collected by non-systematic assessment
+ Solicited (dosing symptoms from daily logs) - collected by systematic assessment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baked Egg Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol. Baked Egg: Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain+ | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hugh A. Sampson | Icahn School of Medicine at Mount Sinai | 212-659-9426 | hugh.sampson@mssm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2018 | Sep 21, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 16, 2016 | Sep 24, 2018 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baked Egg | Drug | Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions. |
|
Incidence of all serious adverse events during the study. No statistical analyses were performed since there were no events in 2 of the 3 treatment groups and only 1 event in the third so it would not be meaningful. |
| up to 3 years |
| Number of Participants With Unrestricted Consumption of Unbaked Egg | Number of participants who reported consumption of concentrated (unbaked) egg in their diet on the long-term follow-up questionnaire 3 years after randomization, indicating unrestricted consumption of unbaked egg. This is a qualitative questionnaire asking participants about egg in their diet, symptoms, and what treatment they received for their allergic reactions. | 3 years after randomization |
| Denver |
| Colorado |
| 80206 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 100029 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Withdrawal by Subject |
|
| Non-compliance |
|
| Developed Eosinophilic Esophagitis (EoE) |
|
| Refused SU OFC |
|
| BG001 | Egg OIT Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| BG002 | Egg OIT Assigned | Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Other Food Allergy History | Count of Participants | Participants |
|
| Asthma Severity History | Count of Participants | Participants |
|
| Allergic GI Disease | Count of Participants | Participants |
|
| Allergic Rhinitis | Count of Participants | Participants |
|
| Atopic Dermatitis History | Count of Participants | Participants |
|
| Atopic Dermatitis Score | The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Egg IgE | Assay limits of detection Ranges: 0.01 to 100 kUA/L, Values outside of range were truncated (lower and upper values): 0.05 and 101 kUA/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | kUA/L |
|
| Baseline Total IgE | Assay limits of detection ranges: Total IgE: 5000 kU/L upper limit, Values above range were truncated: 5001 kU/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | kUA/L |
|
| Baseline Egg IgG4 | Assay limits of detection ranges: 0.07 to 30 mgA/L, Values outside of range were truncated (lower and upper values): 0.035 and 31 mgA/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | mgA/L |
|
| Baseline Egg %IgE | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | % IgE |
|
| Baseline Ratio IgG4/IgE | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | ratio |
|
| Baseline Ovalbumin IgE | Assay limits of detection ranges: 0.01 to 100 kUA/L, Values outside of range were truncated (lower and upper values): 0.05 and 101 kUA/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | kUA/L |
|
| Baseline Ovomucoid IgE | Assay limits of detection ranges: 0.01 to 100 kUA/L, Values outside of range were truncated (lower and upper values): 0.05 and 101 kUA/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | kUA/L |
|
| Baseline Ovalbumin IgG4 | Assay limits of detection ranges: 0.07 to 30 mgA/L, Values outside of range were truncated (lower and upper values): 0.035 and 31 mgA/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | mgA/L |
|
| Baseline Ovomucoid IgG4 | Assay limits of detection ranges: 0.07 to 30 mgA/L, Values outside of range were truncated (lower and upper values): 0.035 and 31 mgA/L | One participant in Egg OIT Assigned arm had no plasma | Median | Inter-Quartile Range | mgA/L |
|
| Baseline Egg Skin Prick Test (SPT) | Skin prick tests performed using study approved procedures for food and environmental allergens. A skin test probe is pressed through a commercial extract of an allergen into the epidermis. | Median | Inter-Quartile Range | mms |
|
| Baseline Milk SPT | Median | Inter-Quartile Range | mms |
|
| Baseline Peanut SPT | One Egg OIT Assigned subject refused to complete the peanut SPT at baseline | Median | Inter-Quartile Range | mms |
|
| Baseline Tree SPT | Median | Inter-Quartile Range | mms |
|
| Baseline Grass SPT | Median | Inter-Quartile Range | mms |
|
| Baseline Weed SPT | Median | Inter-Quartile Range | mms |
|
| Baseline Mold SPT | Median | Inter-Quartile Range | mms |
|
| Baseline Cockroach SPT | Median | Inter-Quartile Range | mms |
|
| OG001 | Egg OIT Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
| OG002 | Egg OIT Assigned | Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. |
|
|
|
| Secondary | Desensitization to >= 4.444 Grams Egg White Solid. | Development of desensitization to able to successfully consume >=4444 mg egg white protein during a desensitization OFC on therapy at 1 year and 2 years. | Posted | Count of Participants | Participants | 1 Year and 2 Years |
|
|
|
|
| Secondary | Incidence of All Serious Adverse Events | Incidence of all serious adverse events during the study. No statistical analyses were performed since there were no events in 2 of the 3 treatment groups and only 1 event in the third so it would not be meaningful. | All treated participants | Posted | Count of Participants | Participants | up to 3 years |
|
|
|
| Secondary | Number of Participants With Unrestricted Consumption of Unbaked Egg | Number of participants who reported consumption of concentrated (unbaked) egg in their diet on the long-term follow-up questionnaire 3 years after randomization, indicating unrestricted consumption of unbaked egg. This is a qualitative questionnaire asking participants about egg in their diet, symptoms, and what treatment they received for their allergic reactions. | Participants who completed the long term follow-up questionnaire 3 years after randomization are included. | Posted | Count of Participants | Participants | 3 years after randomization |
|
|
|
|
| Other Pre-specified | Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results. | Changes in egg-specific IgE and IgG4, changes in SPT mean wheal diameters, basophil reactivity, Th2 and Treg values. | Data not reported because these are for tertiary objectives that are exploratory. | Posted | 2 Years |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 27 |
| 27 |
| EG001 | Egg OIT Randomized | Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. | 0 | 23 | 0 | 23 | 23 | 23 |
| EG002 | Egg OIT Assigned | Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol. Egg Oral Immunotherapy: Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. | 0 | 39 | 1 | 39 | 39 | 39 |
| Eyelid oedema+ | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ocular hyperaemia+ | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal discomfort* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Abdominal discomfort+ | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Abdominal pain upper* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Abdominal pain* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Abdominal pain+ | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diarrhoea* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Diarrhoea+ | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dyspepsia+ | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Flatulence+ | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Gastrointestinal disorder* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Lip swelling+ | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nausea* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Nausea+ | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oral discomfort+ | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oral disorder+ | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Tongue pruritus+ | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Vomiting* | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Vomiting+ | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Chest discomfort+ | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Influenza like illness* | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Malaise+ | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pyrexia* | General disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Allergy to animal* | Immune system disorders | MedDRA (21.1) | Non-systematic Assessment |
|
| Hypersensitivity* | Immune system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Bronchitis* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Cellulitis* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Croup infectious* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Ear infection* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Febrile infection* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Gastroenteritis viral* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Gastroenteritis* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Gastrointestinal viral infection* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Influenza* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Lice infestation* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Localised infection* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Otitis media* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Pharyngitis streptococcal* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Sinusitis* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection* | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
|
| Viral infection* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection* | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
|
| Concussion* | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
|
| Headache* | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Headache+ | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Asthma* | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Cough* | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Cough+ | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nasal congestion* | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Nasal congestion+ | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nasal pruritus+ | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oropharyngeal discomfort+ | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oropharyngeal pain* | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Rhinorrhoea* | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Sneezing+ | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Throat irritation+ | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Wheezing* | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Wheezing+ | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dermatitis atopic* | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Eczema* | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Eczema+ | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pruritus+ | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Rash papular* | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash* | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash+ | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Urticaria+ | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Flushing+ | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hispanic or Latino origin |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Barnard's Exact Test |
| 0.151 |
| Risk Difference (RD) |
| 17.7 |
| 2-Sided |
| 95 |
| -2.3 |
| 37.7 |
| Superiority |
| % participants desensitized to >=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized | Barnard's Exact Test | 0.002 | Risk Difference (RD) | 44.3 | 2-Sided | 95 | 19.4 | 69.2 | Superiority |
| % participants desensitized to >=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned | Barnard's Exact Test | 0.181 | Risk Difference (RD) | 17.5 | 2-Sided | 95 | -6.3 | 41.3 | Superiority |
| Barnard's Exact Test |
| 0.023 |
| Risk Difference (RD) |
| 33.7 |
| 2-Sided |
| 95 |
| 7.2 |
| 60.1 |
| Superiority |