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.
COMPLETED
PHASE1/PHASE2
73 participants
40 Weeks
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
| 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
| 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 WeeksPopulation: 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
| 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 weeksPopulation: 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
| 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 weeksPopulation: 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
| 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 WeeksPopulation: 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
| 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
High Dose ADP101, Pediatric Safety Population
Pooled PBO, Pediatric Safety Population
Low Dose ADP101, All-participants Safety Population
High Dose ADP101, All-participants Safety Population
Pooled PBO, All-participants Safety Population
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place