Trial Outcomes & Findings for Study of Milk Allergy and Tolerance in Children (NCT NCT00778258)
NCT ID: NCT00778258
Last Updated: 2016-03-30
Results Overview
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Randomization through end of study (up to 36 months)
Results posted on
2016-03-30
Participant Flow
Participant milestones
| Measure |
Dose Escalation - Reacted to Pizza
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Rice Pudding
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Non-baked Milk
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Pizza
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Rice Pudding
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance- Reacted to Non-baked Milk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Not Randomized - Comparison
Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
|
Non-Randomized - Reacted to Muffin
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
|
Non-Randomized - Tolerant to Baked and Non-baked Milk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
5
|
20
|
15
|
6
|
23
|
34
|
41
|
10
|
|
Overall Study
COMPLETED
|
9
|
3
|
10
|
12
|
6
|
13
|
19
|
26
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
10
|
3
|
0
|
10
|
15
|
15
|
4
|
Reasons for withdrawal
| Measure |
Dose Escalation - Reacted to Pizza
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Rice Pudding
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Non-baked Milk
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Pizza
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Rice Pudding
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance- Reacted to Non-baked Milk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Not Randomized - Comparison
Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
|
Non-Randomized - Reacted to Muffin
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
|
Non-Randomized - Tolerant to Baked and Non-baked Milk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
3
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
8
|
2
|
0
|
6
|
12
|
12
|
4
|
|
Overall Study
New Contraindication
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of Milk Allergy and Tolerance in Children
Baseline characteristics by cohort
| Measure |
Dose Escalation - Reacted to Pizza
n=16 Participants
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Rice Pudding
n=5 Participants
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Non-baked Milk
n=20 Participants
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Pizza
n=15 Participants
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Rice Pudding
n=6 Participants
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance- Reacted to Non-baked Milk
n=23 Participants
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Not Randomized - Comparison
n=34 Participants
Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
|
Non-Randomized - Reacted to Muffin
n=41 Participants
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
|
Non-Randomized - Tolerant to Baked and Non-baked Milk
n=10 Participants
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
6.6 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
6.2 years
STANDARD_DEVIATION 1.6 • n=107 Participants
|
7.7 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
7.3 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
6.7 years
STANDARD_DEVIATION 2.7 • n=31 Participants
|
6.3 years
STANDARD_DEVIATION 2.1 • n=30 Participants
|
6.5 years
STANDARD_DEVIATION 2.3 • n=3 Participants
|
7.5 years
STANDARD_DEVIATION 1.9 • n=6 Participants
|
6.5 years
STANDARD_DEVIATION 2.2 • n=114 Participants
|
6.9 years
STANDARD_DEVIATION 2.2
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
52 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
23 Participants
n=3 Participants
|
29 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
118 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
38 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
159 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
18 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
141 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
11 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
5 participants
n=107 Participants
|
20 participants
n=206 Participants
|
15 participants
n=7 Participants
|
6 participants
n=31 Participants
|
23 participants
n=30 Participants
|
34 participants
n=3 Participants
|
41 participants
n=6 Participants
|
10 participants
n=114 Participants
|
170 participants
|
|
Baseline Boiled Milk Wheal
|
7.3 Mm
STANDARD_DEVIATION 2.4 • n=99 Participants
|
6.1 Mm
STANDARD_DEVIATION 3.5 • n=107 Participants
|
6.6 Mm
STANDARD_DEVIATION 2.8 • n=206 Participants
|
7.6 Mm
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.6 Mm
STANDARD_DEVIATION 2.0 • n=31 Participants
|
5.5 Mm
STANDARD_DEVIATION 3.2 • n=30 Participants
|
7.7 Mm
STANDARD_DEVIATION 4.5 • n=3 Participants
|
7.9 Mm
STANDARD_DEVIATION 2.6 • n=6 Participants
|
3.4 Mm
STANDARD_DEVIATION 2.5 • n=114 Participants
|
6.9 Mm
STANDARD_DEVIATION 3.2
|
|
Baseline Milk Extract Wheal
|
8.9 Mm
STANDARD_DEVIATION 2.4 • n=99 Participants
|
8.6 Mm
STANDARD_DEVIATION 1.2 • n=107 Participants
|
9.1 Mm
STANDARD_DEVIATION 3.4 • n=206 Participants
|
8.9 Mm
STANDARD_DEVIATION 2.8 • n=7 Participants
|
8.1 Mm
STANDARD_DEVIATION 2.7 • n=31 Participants
|
8.5 Mm
STANDARD_DEVIATION 3.4 • n=30 Participants
|
9.0 Mm
STANDARD_DEVIATION 3.8 • n=3 Participants
|
10.5 Mm
STANDARD_DEVIATION 3.7 • n=6 Participants
|
5.0 Mm
STANDARD_DEVIATION 2.6 • n=114 Participants
|
8.9 Mm
STANDARD_DEVIATION 3.4
|
|
Baseline Unheated Milk Wheal
|
10.4 Mm
STANDARD_DEVIATION 4.2 • n=99 Participants
|
11.6 Mm
STANDARD_DEVIATION 4.2 • n=107 Participants
|
8.3 Mm
STANDARD_DEVIATION 2.5 • n=206 Participants
|
8.8 Mm
STANDARD_DEVIATION 2.3 • n=7 Participants
|
10.0 Mm
STANDARD_DEVIATION 2.7 • n=31 Participants
|
9.7 Mm
STANDARD_DEVIATION 4.0 • n=30 Participants
|
9.6 Mm
STANDARD_DEVIATION 4.3 • n=3 Participants
|
10.1 Mm
STANDARD_DEVIATION 2.6 • n=6 Participants
|
5.6 Mm
STANDARD_DEVIATION 2.8 • n=114 Participants
|
9.3 Mm
STANDARD_DEVIATION 3.4
|
|
Baseline Cow's Milk IgE
|
10.3 kUa/L
STANDARD_DEVIATION 11.5 • n=99 Participants
|
10.5 kUa/L
STANDARD_DEVIATION 7.8 • n=107 Participants
|
5.3 kUa/L
STANDARD_DEVIATION 5.4 • n=206 Participants
|
7.8 kUa/L
STANDARD_DEVIATION 9.7 • n=7 Participants
|
13.7 kUa/L
STANDARD_DEVIATION 13.1 • n=31 Participants
|
4.1 kUa/L
STANDARD_DEVIATION 4.5 • n=30 Participants
|
14.7 kUa/L
STANDARD_DEVIATION 21.3 • n=3 Participants
|
15.1 kUa/L
STANDARD_DEVIATION 12.7 • n=6 Participants
|
4.9 kUa/L
STANDARD_DEVIATION 8.1 • n=114 Participants
|
10.6 kUa/L
STANDARD_DEVIATION 13.6
|
PRIMARY outcome
Timeframe: Randomization through end of study (up to 36 months)Population: Randomized intent-to-treat
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=44 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm
|
26 participants
|
31 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months, 24 monthsPopulation: Randomized intent-to-treat
Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=44 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months
Progressed at 12 Months
|
18 participants
|
18 participants
|
—
|
—
|
—
|
|
Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months
Progressed at 24 Months
|
23 participants
|
27 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months, 24 months, and 36 monthsPopulation: Randomized intent-to-treat
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=44 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months
Tolerant at 12 Month
|
29.3 percentage of participants
|
15.9 percentage of participants
|
—
|
—
|
—
|
|
Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months
Tolerant at 24 Months
|
43.9 percentage of participants
|
29.5 percentage of participants
|
—
|
—
|
—
|
|
Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months
Tolerant at 36 Months
|
53.7 percentage of participants
|
43.2 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomization through end of study (up to 36 months)Population: Randomized intent-to-treat
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.
Outcome measures
| Measure |
Dose-Escalation Group
n=31 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=11 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=43 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Percent of Participants Becoming Tolerant to Unheated Cow's Milk
|
38.7 percentage of participants
|
54.5 percentage of participants
|
53.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Intent-to-treat
This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=31 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=11 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
n=43 Participants
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
n=10 Participants
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity
|
41.0 percentage of max basophil degranulation
Interval 16.9 to 76.7
|
29.3 percentage of max basophil degranulation
Interval 12.8 to 47.8
|
45.6 percentage of max basophil degranulation
Interval 13.9 to 85.3
|
20.3 percentage of max basophil degranulation
Interval 6.3 to 55.1
|
8.9 percentage of max basophil degranulation
Interval 6.7 to 32.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: Intent-to-treat
This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=31 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=11 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
n=43 Participants
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
n=10 Participants
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity
Beta-lactoglobulin IgE
|
1.9 kUa/L
Interval 0.6 to 4.0
|
0.6 kUa/L
Interval 0.2 to 2.4
|
1.3 kUa/L
Interval 0.4 to 3.5
|
0.4 kUa/L
Interval 0.2 to 2.3
|
0.2 kUa/L
Interval 0.2 to 0.4
|
|
Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity
Casein IgE
|
12.3 kUa/L
Interval 3.4 to 17.9
|
4.1 kUa/L
Interval 1.6 to 9.6
|
5.6 kUa/L
Interval 2.0 to 12.9
|
1.6 kUa/L
Interval 0.7 to 3.6
|
0.8 kUa/L
Interval 0.2 to 1.6
|
|
Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity
Cow's Milk IgE
|
12.1 kUa/L
Interval 5.0 to 21.1
|
5.4 kUa/L
Interval 2.1 to 12.2
|
7.7 kUa/L
Interval 3.9 to 19.1
|
3.5 kUa/L
Interval 1.7 to 5.6
|
0.9 kUa/L
Interval 0.2 to 4.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Intent-to-treat
This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=31 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=11 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
n=43 Participants
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
n=10 Participants
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity
Max Basophil Assessment
|
1160.0 cells/µL
Interval 635.0 to 1981.0
|
717.0 cells/µL
Interval 456.0 to 982.0
|
1589.5 cells/µL
Interval 1287.5 to 3972.0
|
934.0 cells/µL
Interval 459.0 to 1669.0
|
524.0 cells/µL
Interval 319.0 to 1087.0
|
|
Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity
Tregs
|
4.2 cells/µL
Interval 2.4 to 7.0
|
6.2 cells/µL
Interval 2.4 to 8.5
|
7.5 cells/µL
Interval 2.4 to 12.5
|
5.2 cells/µL
Interval 3.5 to 10.1
|
4.2 cells/µL
Interval 2.2 to 8.5
|
SECONDARY outcome
Timeframe: Randomization through end of study (up to 36 months)Population: Randomized intent-to-treat participants who achieved tolerance
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.
Outcome measures
| Measure |
Dose-Escalation Group
n=12 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=6 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=23 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance
|
24.0 months
Standard Deviation 12.6
|
17.8 months
Standard Deviation 12.7
|
19.6 months
Standard Deviation 10.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24, Month 36Population: Intent-to-treat
Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.
Outcome measures
| Measure |
Dose-Escalation Group
n=41 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=31 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=11 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
n=43 Participants
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
n=10 Participants
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey
Baseline
|
4.6 Ratio
Interval 3.0 to 6.5
|
4.6 Ratio
Interval 1.8 to 9.0
|
5.5 Ratio
Interval 0.9 to 14.2
|
2.1 Ratio
Interval 1.0 to 6.6
|
1.6 Ratio
Interval 1.0 to 9.4
|
|
Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey
Month 12 Visit
|
7.7 Ratio
Interval 4.7 to 20.7
|
3.0 Ratio
Interval 2.0 to 12.2
|
4.5 Ratio
Interval 3.1 to 11.5
|
2.3 Ratio
Interval 1.1 to 4.3
|
2.2 Ratio
Interval 1.0 to 7.0
|
|
Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey
Month 24 Visit
|
3.7 Ratio
Interval 1.4 to 7.6
|
3.3 Ratio
Interval 3.0 to 9.2
|
4.8 Ratio
Interval 2.8 to 171.2
|
1.0 Ratio
Interval 0.9 to 6.2
|
2.6 Ratio
Interval 1.0 to 3.7
|
|
Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey
Month 36 Visit
|
4.6 Ratio
Interval 2.5 to 9.0
|
2.5 Ratio
Interval 2.1 to 13.7
|
5.1 Ratio
Interval 0.4 to 6.2
|
1.1 Ratio
Interval 1.0 to 2.6
|
2.3 Ratio
Interval 1.0 to 27.3
|
SECONDARY outcome
Timeframe: Month 36Population: Randomized and comparison participants
Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.
Outcome measures
| Measure |
Dose-Escalation Group
n=85 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
|
Maintenance Group
n=34 Participants
Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
|
Group 4 - Milk
n=41 Participants
Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
|
Group 4 = Milk
Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
|
Group 5 = Passed All
Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
|
|---|---|---|---|---|---|
|
Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk
|
48.2 percent participants
|
0.0 percent participants
|
0.0 percent participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24, and Month 36Population: Data were not collected and therefore no analyses could be performed.
This outcome measure was not well defined in the protocol and was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the time complete milk tolerance was establishedPopulation: Data were not collected and therefore no analyses could be performed.
This outcome measure was not well defined in the protocol and was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Dose Escalation - Reacted to Pizza
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Dose Escalation - Reacted to Rice Pudding
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Escalation - Reacted to Non-baked Milk
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Maintenance - Reacted to Pizza
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Maintenance - Reacted to Rice Pudding
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Maintenance - Reacted to Non-baked Milk
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Not Randomized - Comparison
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Non-Randomized - Reacted to Muffin
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Non-Randomized - Tolerant to Baked and Non-baked Milk
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation - Reacted to Pizza
n=16 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Rice Pudding
n=5 participants at risk
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Non-baked Milk
n=20 participants at risk
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Pizza
n=15 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Rice Pudding
n=6 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Non-baked Milk
n=23 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Not Randomized - Comparison
n=34 participants at risk
Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
|
Non-Randomized - Reacted to Muffin
n=41 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
|
Non-Randomized - Tolerant to Baked and Non-baked Milk
n=10 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
Other adverse events
| Measure |
Dose Escalation - Reacted to Pizza
n=16 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Rice Pudding
n=5 participants at risk
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Dose Escalation - Reacted to Non-baked Milk
n=20 participants at risk
At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Pizza
n=15 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Rice Pudding
n=6 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Maintenance - Reacted to Non-baked Milk
n=23 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
|
Not Randomized - Comparison
n=34 participants at risk
Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
|
Non-Randomized - Reacted to Muffin
n=41 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
|
Non-Randomized - Tolerant to Baked and Non-baked Milk
n=10 participants at risk
At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
|
|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Endocrine disorders
Growth hormone deficiency
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
8.7%
2/23 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Immune system disorders
Allergy to animal
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Immune system disorders
Food allergy
|
93.8%
15/16 • Number of events 53 • Enrollment through end of study (up to 3 years)
|
80.0%
4/5 • Number of events 7 • Enrollment through end of study (up to 3 years)
|
65.0%
13/20 • Number of events 31 • Enrollment through end of study (up to 3 years)
|
93.3%
14/15 • Number of events 66 • Enrollment through end of study (up to 3 years)
|
100.0%
6/6 • Number of events 19 • Enrollment through end of study (up to 3 years)
|
69.6%
16/23 • Number of events 48 • Enrollment through end of study (up to 3 years)
|
38.2%
13/34 • Number of events 18 • Enrollment through end of study (up to 3 years)
|
95.1%
39/41 • Number of events 104 • Enrollment through end of study (up to 3 years)
|
20.0%
2/10 • Number of events 11 • Enrollment through end of study (up to 3 years)
|
|
Immune system disorders
Hypersensitivity
|
12.5%
2/16 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Immune system disorders
Milk allergy
|
56.2%
9/16 • Number of events 18 • Enrollment through end of study (up to 3 years)
|
60.0%
3/5 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
90.0%
18/20 • Number of events 40 • Enrollment through end of study (up to 3 years)
|
80.0%
12/15 • Number of events 24 • Enrollment through end of study (up to 3 years)
|
83.3%
5/6 • Number of events 12 • Enrollment through end of study (up to 3 years)
|
100.0%
23/23 • Number of events 49 • Enrollment through end of study (up to 3 years)
|
14.7%
5/34 • Number of events 6 • Enrollment through end of study (up to 3 years)
|
34.1%
14/41 • Number of events 19 • Enrollment through end of study (up to 3 years)
|
10.0%
1/10 • Number of events 8 • Enrollment through end of study (up to 3 years)
|
|
Immune system disorders
Seasonal allergy
|
18.8%
3/16 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
20.0%
1/5 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
15.0%
3/20 • Number of events 3 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
17.4%
4/23 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 3 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Ear infection
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
8.7%
2/23 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
10.0%
1/10 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Gastroenteritis viral
|
18.8%
3/16 • Number of events 3 • Enrollment through end of study (up to 3 years)
|
20.0%
1/5 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
20.0%
3/15 • Number of events 3 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
17.4%
4/23 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
10.0%
1/10 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
H1N1 influenza
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Oral viral infection
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
33.3%
2/6 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Otitis media
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
10.0%
1/10 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
4/16 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
20.0%
1/5 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
20.0%
4/20 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
33.3%
5/15 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
13.0%
3/23 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
5.9%
2/34 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
9.8%
4/41 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
10.0%
1/10 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
8.7%
2/23 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Investigations
Weight increased
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
37.5%
6/16 • Number of events 9 • Enrollment through end of study (up to 3 years)
|
60.0%
3/5 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
20.0%
4/20 • Number of events 6 • Enrollment through end of study (up to 3 years)
|
20.0%
3/15 • Number of events 6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
5.9%
2/34 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
14.6%
6/41 • Number of events 6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
12.5%
2/16 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
4.9%
2/41 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
2/16 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
13.3%
2/15 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
25.0%
4/16 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
5.0%
1/20 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
20.0%
3/15 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
21.7%
5/23 • Number of events 7 • Enrollment through end of study (up to 3 years)
|
8.8%
3/34 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
9.8%
4/41 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
6.7%
1/15 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
16.7%
1/6 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
18.8%
3/16 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
20.0%
1/5 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
20.0%
4/20 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
26.7%
4/15 • Number of events 7 • Enrollment through end of study (up to 3 years)
|
50.0%
3/6 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
8.7%
2/23 • Number of events 4 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
9.8%
4/41 • Number of events 5 • Enrollment through end of study (up to 3 years)
|
10.0%
1/10 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
6.2%
1/16 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
0.00%
0/15 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
0.00%
0/23 • Enrollment through end of study (up to 3 years)
|
0.00%
0/34 • Enrollment through end of study (up to 3 years)
|
0.00%
0/41 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Enrollment through end of study (up to 3 years)
|
0.00%
0/5 • Enrollment through end of study (up to 3 years)
|
0.00%
0/20 • Enrollment through end of study (up to 3 years)
|
13.3%
2/15 • Number of events 2 • Enrollment through end of study (up to 3 years)
|
0.00%
0/6 • Enrollment through end of study (up to 3 years)
|
4.3%
1/23 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
2.9%
1/34 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
2.4%
1/41 • Number of events 1 • Enrollment through end of study (up to 3 years)
|
0.00%
0/10 • Enrollment through end of study (up to 3 years)
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place