Trial Outcomes & Findings for ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (NCT NCT04856865)

NCT ID: NCT04856865

Last Updated: 2024-05-16

Results Overview

The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

73 participants

Primary outcome timeframe

40 Weeks

Results posted on

2024-05-16

Participant Flow

Eligible participants were randomized in a 2:2:1:1 ratio to 1 of 4 arms, with 2 arms in each dosing regimen (low or high), to receive daily oral doses of study drug (either ADP101 or matching placebo) in a blinded fashion. Data from placebo participants (high-dose or low-dose) was analyzed in a pooled fashion (Pooled Placebo)

Participant milestones

Participant milestones
Measure
Low Dose ADP101
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High Dose ADP101
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
Overall Study
STARTED
25
24
24
Overall Study
COMPLETED
19
16
21
Overall Study
NOT COMPLETED
6
8
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Low Dose ADP101
n=25 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High Dose ADP101
n=24 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo
n=24 Participants
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo (see randomization scheme in pre-assignment details) over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
Total
n=73 Participants
Total of all reporting groups
Age, Categorical
<=18 years
21 Participants
n=25 Participants
20 Participants
n=24 Participants
20 Participants
n=24 Participants
61 Participants
n=73 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=25 Participants
4 Participants
n=24 Participants
4 Participants
n=24 Participants
12 Participants
n=73 Participants
Age, Categorical
>=65 years
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=24 Participants
0 Participants
n=73 Participants
Age, Continuous
13.9 years
STANDARD_DEVIATION 9.9 • n=25 Participants
12.1 years
STANDARD_DEVIATION 6 • n=24 Participants
14.8 years
STANDARD_DEVIATION 11.3 • n=24 Participants
13.6 years
STANDARD_DEVIATION 9.3 • n=73 Participants
Age, Customized
Mean (SD) age (years) of pediatric ITT population
10.3 years
STANDARD_DEVIATION 3.4 • n=21 Participants • Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization
9.9 years
STANDARD_DEVIATION 2.8 • n=20 Participants • Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization
10.1 years
STANDARD_DEVIATION 3.5 • n=20 Participants • Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization
10.1 years
STANDARD_DEVIATION 3.2 • n=61 Participants • Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization
Sex/Gender, Customized
Gender · Female
7 Participants
n=21 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
6 Participants
n=20 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
7 Participants
n=20 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
20 Participants
n=61 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
Sex/Gender, Customized
Gender · Male
14 Participants
n=21 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
14 Participants
n=20 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
13 Participants
n=20 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
41 Participants
n=61 Participants • Primary analysis population was the pediatric ITT population, age 4-17 at the time of randomization
Sex: Female, Male
Female
10 Participants
n=25 Participants
8 Participants
n=24 Participants
11 Participants
n=24 Participants
29 Participants
n=73 Participants
Sex: Female, Male
Male
15 Participants
n=25 Participants
16 Participants
n=24 Participants
13 Participants
n=24 Participants
44 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=25 Participants
4 Participants
n=24 Participants
0 Participants
n=24 Participants
5 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=25 Participants
20 Participants
n=24 Participants
22 Participants
n=24 Participants
65 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=25 Participants
0 Participants
n=24 Participants
2 Participants
n=24 Participants
3 Participants
n=73 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=24 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
Asian
6 Participants
n=25 Participants
2 Participants
n=24 Participants
5 Participants
n=24 Participants
13 Participants
n=73 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=24 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=25 Participants
0 Participants
n=24 Participants
3 Participants
n=24 Participants
3 Participants
n=73 Participants
Race (NIH/OMB)
White
18 Participants
n=25 Participants
20 Participants
n=24 Participants
14 Participants
n=24 Participants
52 Participants
n=73 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=24 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=25 Participants
2 Participants
n=24 Participants
2 Participants
n=24 Participants
5 Participants
n=73 Participants
Region of Enrollment
United States
25 Participants
n=25 Participants
24 Participants
n=24 Participants
24 Participants
n=24 Participants
73 Participants
n=73 Participants
Primary analysis population (pediatric ITT)
21 Participants
n=25 Participants
20 Participants
n=24 Participants
20 Participants
n=24 Participants
61 Participants
n=73 Participants

PRIMARY outcome

Timeframe: 40 Weeks

Population: The primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization

The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.

Outcome measures

Outcome measures
Measure
Low Dose ADP101
n=21 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High Dose ADP101
n=20 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo
n=20 Participants
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
600mg Desensitization in at Least One Qualifying Food
8 Participants
11 Participants
4 Participants

SECONDARY outcome

Timeframe: 40 weeks

Population: Primary analysis population was the pediatric ITT population, age 4-17 years at the time of randomization

Proportion of participants in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.

Outcome measures

Outcome measures
Measure
Low Dose ADP101
n=21 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High Dose ADP101
n=20 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo
n=20 Participants
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
1000mg Desensitization Threshold in Pediatric ITT Population
5 Participants
10 Participants
3 Participants

SECONDARY outcome

Timeframe: 40 weeks

Population: Primary analysis population is the pediatric ITT population age 4-17 years at the time of randomization

Proportion of participants with \>=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 600mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.

Outcome measures

Outcome measures
Measure
Low Dose ADP101
n=21 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High Dose ADP101
n=20 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo
n=20 Participants
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
2 Participants
5 Participants
0 Participants

SECONDARY outcome

Timeframe: 40 Weeks

Population: The primary analysis population is the pediatric ITT population, age 4-17 years at the time of randomization

Proportion of participants with \>=2 qualifying FAs in the pediatric ITT population (age 4-17 at randomization) who tolerated the 1000mg level of each of 2 or more qualifying foods without dose limiting symptoms at the Week 40 Exit DBPCFC.

Outcome measures

Outcome measures
Measure
Low Dose ADP101
n=21 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
High Dose ADP101
n=20 Participants
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101:Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
Pooled Placebo
n=20 Participants
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo:Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population
1 Participants
4 Participants
0 Participants

Adverse Events

Low Dose ADP101, Pediatric Safety Population

Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths

High Dose ADP101, Pediatric Safety Population

Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths

Pooled PBO, Pediatric Safety Population

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Low Dose ADP101, All-participants Safety Population

Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths

High Dose ADP101, All-participants Safety Population

Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths

Pooled PBO, All-participants Safety Population

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Low Dose ADP101, Pediatric Safety Population
n=21 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period.
High Dose ADP101, Pediatric Safety Population
n=20 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period.
Pooled PBO, Pediatric Safety Population
n=20 participants at risk
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period.
Low Dose ADP101, All-participants Safety Population
n=25 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period.
High Dose ADP101, All-participants Safety Population
n=24 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period.
Pooled PBO, All-participants Safety Population
n=24 participants at risk
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period.
Immune system disorders
Anaphylaxis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Number of events 1 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure
Low Dose ADP101, Pediatric Safety Population
n=21 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period.
High Dose ADP101, Pediatric Safety Population
n=20 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period.
Pooled PBO, Pediatric Safety Population
n=20 participants at risk
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period.
Low Dose ADP101, All-participants Safety Population
n=25 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period.
High Dose ADP101, All-participants Safety Population
n=24 participants at risk
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period.
Pooled PBO, All-participants Safety Population
n=24 participants at risk
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period.
Gastrointestinal disorders
Abdominal pain
47.6%
10/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
30.0%
6/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
30.0%
6/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
44.0%
11/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
33.3%
8/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Nausea
42.9%
9/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
48.0%
12/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
33.3%
8/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.7%
4/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Oral pruritis
23.8%
5/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
5/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
36.0%
9/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
33.3%
8/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
29.2%
7/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Abdominal pain upper
19.0%
4/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
4/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
37.5%
9/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Vomiting
28.6%
6/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
5/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
4/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
28.0%
7/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
29.2%
7/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.7%
4/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Diarrhoea
23.8%
5/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
37.5%
9/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Paresthesia oral
38.1%
8/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
32.0%
8/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.8%
5/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Abdominal discomfort
23.8%
5/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
4/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Tongue pruritis
19.0%
4/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.0%
4/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Lip swelling
14.3%
3/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.0%
3/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Dyspepsia
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Dysphagia
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Hypoaesthesia oral
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Lip erythema
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Lip pruritis
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Salivary hypersecretion
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Constipation
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Dental caries
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Flatulence
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Lip oedema
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Oral discomfort
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Retching
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
33.3%
7/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
32.0%
8/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
29.2%
7/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Cough
28.6%
6/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
5/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
32.0%
8/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.7%
4/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Throat irritation
23.8%
5/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
4/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
5/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
29.2%
7/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
19.0%
4/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
19.0%
4/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.0%
4/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Sneezing
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Throat tightness
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Wheezing
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Nasal pruritis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Throat clearing
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
COVID-19
28.6%
6/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
30.0%
6/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
32.0%
8/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
37.5%
9/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Upper respiratory tract infection
19.0%
4/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
5/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Viral infection
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Gastroenteritis viral
14.3%
3/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.0%
3/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Nasopharyngitis
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
4/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.7%
4/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Ear infection
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Influenza
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Otitis media
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Croup infectious
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Gastroenteritis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Gastroenteritis norovirus
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Laryngitis viral
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Otitis media acute
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Pulpitis dental
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Urticaria
33.3%
7/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
30.0%
6/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
35.0%
7/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
36.0%
9/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
29.2%
7/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
29.2%
7/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Pruritis
33.3%
7/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
5/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
32.0%
8/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.8%
5/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
25.0%
6/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Erythema
14.3%
3/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
4/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.0%
3/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.7%
4/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Rash
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.0%
3/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Angioedema
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.8%
5/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Acne
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Granuloma annulare
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Perioral dermatitis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Immune system disorders
Anaphylactic reaction
38.1%
8/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
45.0%
9/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
55.0%
11/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
40.0%
10/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
45.8%
11/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
54.2%
13/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Immune system disorders
Hypersensitivity
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Immune system disorders
Seasonal allergy
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Immune system disorders
Food allergy
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Nervous system disorders
Headache
23.8%
5/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
20.0%
5/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
16.7%
4/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Nervous system disorders
Dizziness
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Nervous system disorders
Lethargy
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Nervous system disorders
Paraesthesia
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Nervous system disorders
Syncope
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
General disorders
Chest discomfort
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.0%
3/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
General disorders
Pyrexia
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
General disorders
Fatigue
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
General disorders
Chills
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
General disorders
Feeling abnormal
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
General disorders
Swelling face
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Arthropod sting
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Vaccination complication
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Accidental exposure to product
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Contusion
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Scratch
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Injury, poisoning and procedural complications
Sunburn
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Eye disorders
Eye pruritis
9.5%
2/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
15.0%
3/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.0%
2/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
12.5%
3/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Eye disorders
Conjunctivitis allergic
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Eye disorders
Ocular hyperaemia
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Eye disorders
Eye swelling
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Eye disorders
Lacrimation increased
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Ear and labyrinth disorders
Ear pain
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Ear and labyrinth disorders
Ear pruritis
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
10.0%
2/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
8.3%
2/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Ear and labyrinth disorders
Tinnitus
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Vascular disorders
Flushing
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Vascular disorders
Pallor
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Psychiatric disorders
Anxiety
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Psychiatric disorders
Attention deficit hyperactivity disorder
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Psychiatric disorders
Irritability
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Reproductive system and breast disorders
Dysmenorrhea
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
5.0%
1/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.2%
1/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
Gastrointestinal disorders
Eosinophilic oesophagitis
4.8%
1/21 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/20 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
4.0%
1/25 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.
0.00%
0/24 • Adverse Events (AEs) were collected from consent until 14 days after last dose of study drug, up to approximately 52 weeks of treatment. Serious adverse events (SAEs) considered related to ADP101 were to be reported at any time until resolution/stabilization of the SAE.
Allergic reactions were graded according to the Consortium of Food Allergy Research (CoFAR grading system, Jones et al. 2017),including events that met the definition for anaphylaxis. The pediatric Safety population included all pediatric participants (age 4-17 at the time of randomization) who received at least one dose of study drug. The All-participants safety population included all participants (age 4-55 years at the time of randomization) who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Alladapt Immunotherapeutics

Phone: 650-420-3900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place