Trial Outcomes & Findings for Oral Immunotherapy for Childhood Egg Allergy (NCT NCT00461097)
NCT ID: NCT00461097
Last Updated: 2017-12-13
Results Overview
Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy
Results posted on
2017-12-13
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
15
|
|
Overall Study
Had Month 10 (Wk 44) Oral Food Challenge
|
35
|
13
|
|
Overall Study
Had Month 22 (Wk 96) Oral Food Challenge
|
34
|
1
|
|
Overall Study
Had Year 3 (Mnth 36) Oral Food Challenge
|
16
|
0
|
|
Overall Study
Had Year 4 (Mnth 48) Oral Food Challenge
|
7
|
0
|
|
Overall Study
COMPLETED
|
40
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Immunotherapy for Childhood Egg Allergy
Baseline characteristics by cohort
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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
n=15 Participants
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
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.1 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
7.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
52 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
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
48 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
15 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Atopic Dermatitis Total Score
|
3.1 Scores on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
3.0 Scores on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
3.1 Scores on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Total IgE
|
1378.7 kU/L
STANDARD_DEVIATION 1728.6 • n=5 Participants
|
1464.7 kU/L
STANDARD_DEVIATION 1182.7 • n=7 Participants
|
1402.1 kU/L
STANDARD_DEVIATION 1588.1 • n=5 Participants
|
|
Egg IgE
|
32.9 kUA/L
STANDARD_DEVIATION 54.7 • n=5 Participants
|
32.1 kUA/L
STANDARD_DEVIATION 27.3 • n=7 Participants
|
32.7 kUA/L
STANDARD_DEVIATION 48.5 • n=5 Participants
|
|
Egg Skin Prick Test Score
|
11.8 mm
STANDARD_DEVIATION 5.7 • n=5 Participants
|
12.8 mm
STANDARD_DEVIATION 4.3 • n=7 Participants
|
12.1 mm
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Age at Initial Egg Allergic Reaction
|
2.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
1.3 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
2.0 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapyPopulation: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.
Outcome measures
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg
|
27.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Following the blinded desensitization phase at approximately Week 44Population: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.
Outcome measures
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid
|
55.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Initial day of dosingPopulation: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.
Outcome measures
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation
|
22.5 percentage of participants
|
86.7 percentage of participants
|
SECONDARY outcome
Timeframe: Following the blinded desensitization phase at approximately Week 44Population: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.
Outcome measures
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg
|
45.0 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through the 2-year primary endpointPopulation: The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.
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.
Outcome measures
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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
n=15 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 years (48 months)Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.
Outcome measures
| Measure |
Egg Oral Immunotherapy (OIT)
n=40 Participants
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.
|
|---|---|---|
|
Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid
|
52.5 percentage of participants
|
—
|
Adverse Events
Egg Oral Immunotherapy (OIT), 0-2 Years
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo, 0-2 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Egg Oral Immunotherapy (OIT), 2-4 Years
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Egg Oral Immunotherapy (OIT), 0-2 Years
n=40 participants at risk
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
n=15 participants at risk
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
n=36 participants at risk
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).
|
|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
2.8%
1/36 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
Other adverse events
| Measure |
Egg Oral Immunotherapy (OIT), 0-2 Years
n=40 participants at risk
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
n=15 participants at risk
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
n=36 participants at risk
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).
|
|---|---|---|---|
|
Gastrointestinal disorders
Lip swelling
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
4.5%
1/22 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Oral disorder
|
77.5%
31/40 • Number of events 2457 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 9 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
36.4%
8/22 • Number of events 214 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
10/40 • Number of events 15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.3%
2/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
16.7%
6/36 • Number of events 8 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
General disorders
Chest discomfort
|
15.0%
6/40 • Number of events 8 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Eye disorders
Conjunctivitis
|
5.0%
2/40 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Eye disorders
Conjunctivitis allergic
|
5.0%
2/40 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Eye disorders
Eye irritation
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Eye disorders
Eye pruritus
|
12.5%
5/40 • Number of events 71 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
4.5%
1/22 • Number of events 11 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Eye disorders
Lacrimation increased
|
7.5%
3/40 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
3/40 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
8/40 • Number of events 20 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
4.5%
1/22 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
2/40 • Number of events 79 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
General disorders
Influenza like illness
|
10.0%
4/40 • Number of events 7 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
General disorders
Pyrexia
|
20.0%
8/40 • Number of events 11 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
22.2%
8/36 • Number of events 16 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
General disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
General disorders
Fatigue
|
7.5%
3/40 • Number of events 6 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
General disorders
Feeling hot
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Immune system disorders
Hypersensitivity
|
10.0%
4/40 • Number of events 7 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
2.8%
1/36 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Immune system disorders
Seasonal allergy
|
5.0%
2/40 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Bronchitis
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.3%
2/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Croup infectious
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Febrile infection
|
10.0%
4/40 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Gastroenteritis
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Gastroenteritis viral
|
30.0%
12/40 • Number of events 17 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
16.7%
6/36 • Number of events 6 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Impetigo
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Influenza
|
27.5%
11/40 • Number of events 12 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
11.1%
4/36 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Molluscum contagiosum
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
2.8%
1/36 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Nasopharyngitis
|
27.5%
11/40 • Number of events 32 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
33.3%
5/15 • Number of events 12 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
16.7%
6/36 • Number of events 11 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Otitis externa
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Otitis media
|
10.0%
4/40 • Number of events 6 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
26.7%
4/15 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.9%
5/36 • Number of events 8 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.0%
4/40 • Number of events 11 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Pneumonia
|
7.5%
3/40 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Sinusitis
|
20.0%
8/40 • Number of events 13 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.3%
2/15 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.9%
5/36 • Number of events 7 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Skin infection
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Subcutaneous abscess
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
20/40 • Number of events 59 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
60.0%
9/15 • Number of events 10 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
27.8%
10/36 • Number of events 19 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
2.8%
1/36 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Viral infection
|
12.5%
5/40 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
2.8%
1/36 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Viral pharyngitis
|
10.0%
4/40 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Number of events 25 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.3%
2/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
4.5%
1/22 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
2.8%
1/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
15.0%
6/40 • Number of events 10 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.3%
2/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
16.7%
6/36 • Number of events 8 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
65.0%
26/40 • Number of events 182 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
33.3%
5/15 • Number of events 35 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.6%
3/22 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
40.0%
16/40 • Number of events 385 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
33.3%
5/15 • Number of events 27 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
9.1%
2/22 • Number of events 151 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
4/40 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
10/40 • Number of events 42 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
2/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
7.5%
3/40 • Number of events 10 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
13.3%
2/15 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
55.0%
22/40 • Number of events 658 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
18.2%
4/22 • Number of events 36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
52.5%
21/40 • Number of events 72 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
40.0%
6/15 • Number of events 54 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
4.5%
1/22 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.0%
4/40 • Number of events 11 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
15.0%
6/40 • Number of events 11 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
4/40 • Number of events 9 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 14 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 5 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.5%
3/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
70.0%
28/40 • Number of events 424 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 12 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
18.2%
4/22 • Number of events 78 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
7.5%
3/40 • Number of events 4 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
67.5%
27/40 • Number of events 398 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
33.3%
5/15 • Number of events 19 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
22.7%
5/22 • Number of events 18 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Vascular disorders
Flushing
|
45.0%
18/40 • Number of events 43 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
20.0%
3/15 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
9.1%
2/22 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.0%
2/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Ear and labyrinth disorders
Ear pruritus
|
7.5%
3/40 • Number of events 10 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Gastrointestinal disorders
Glossodynia
|
5.0%
2/40 • Number of events 3 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Infections and infestations
Staphylococcal impetigo
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/36 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.5%
1/40 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/15 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
5.6%
2/36 • Number of events 2 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/40 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
6.7%
1/15 • Number of events 1 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
0.00%
0/22 • Baseline through 2 year primary endpoint for Egg OIT and Placebo groups; then for Egg OIT only from 2 to 4 years.
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.
|
Additional Information
Associate Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place