Trial Outcomes & Findings for Peanut Oral Immunotherapy in Children (NCT NCT01867671)
NCT ID: NCT01867671
Last Updated: 2020-03-16
Results Overview
Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.\* \*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
Week 134
Results posted on
2020-03-16
Participant Flow
Participants ages 1 to 3 with a clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut were recruited from 5 clinical centers in the United States from August 2013 to October 2015.
Individuals with a history of severe anaphylaxis (previous hypotension) to peanut were excluded.
Participant milestones
| Measure |
Peanut Oral Immune Therapy (OIT)
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
50
|
|
Overall Study
COMPLETED
|
67
|
22
|
|
Overall Study
NOT COMPLETED
|
29
|
28
|
Reasons for withdrawal
| Measure |
Peanut Oral Immune Therapy (OIT)
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Anaphylaxis
|
0
|
1
|
|
Overall Study
Inability to reach 3 mg peanut/placebo
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
21
|
21
|
Baseline Characteristics
Peanut Oral Immunotherapy in Children
Baseline characteristics by cohort
| Measure |
Peanut Oral Immune Therapy (OIT)
n=96 Participants
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
n=50 Participants
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.1 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.0 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.1 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
50 participants
n=7 Participants
|
146 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 134Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.\* \*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.
Outcome measures
| Measure |
Peanut Oral Immune Therapy (OIT)
n=96 Participants
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
n=50 Participants
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
|
71 Percentage of Participants
Interval 61.7 to 79.9
|
2 Percentage of Participants
Interval 0.0 to 5.9
|
SECONDARY outcome
Timeframe: Week 160Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).
Outcome measures
| Measure |
Peanut Oral Immune Therapy (OIT)
n=96 Participants
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
n=50 Participants
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Percentage of Tolerant Participants at Week 160
|
21 percentage of participants
Interval 12.7 to 29.0
|
2 percentage of participants
Interval 0.0 to 5.9
|
SECONDARY outcome
Timeframe: Week 134, Week 160Population: Participants randomized to the Peanut Oral Immunotherapy (OIT) group
Definition of transient desensitization: A participant who passed the blinded (masked) oral food challenge (OFC) to 10 grams peanut flour (=5 grams peanut protein) at week 134 and failed the week 160 in the Peanut oral immunotherapy (OIT) group.
Outcome measures
| Measure |
Peanut Oral Immune Therapy (OIT)
n=96 Participants
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Count of Participants With Transient Desensitization
Passed Week 134 and Failed Week 160
|
49 Participants
|
—
|
|
Count of Participants With Transient Desensitization
Passed Week 134 and Passed Week 160
|
19 Participants
|
—
|
|
Count of Participants With Transient Desensitization
Failed Week 134 and Failed Week 160
|
27 Participants
|
—
|
|
Count of Participants With Transient Desensitization
Failed Week 134 and Passed Week 160
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 160The highest tolerated cumulative dose of peanut protein during the blinded (masked) oral food challenge (OFC) at Week 160, analyzed within and between both placebo and peanut OIT groups. The highest cumulative dose of peanut protein tolerated for each participant was analyzed as a continuous outcome. Any randomized participant without an evaluable blinded (masked) OFC was imputed as not tolerant. For the continuous highest cumulative dose endpoint, this is defined as having a highest cumulative dose imputed as zero.
Outcome measures
| Measure |
Peanut Oral Immune Therapy (OIT)
n=96 Participants
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
n=50 Participants
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Highest Tolerated Cumulative Dose
|
1645 mg protein
Interval 1338.0 to 1951.0
|
180 mg protein
Interval -244.0 to 605.0
|
SECONDARY outcome
Timeframe: Initial Dose Escalation through Week 160 (Tolerance Assessment)Percentage of participants that withdrew from study participation, listed by study phase (at time of study withdrawal).
Outcome measures
| Measure |
Peanut Oral Immune Therapy (OIT)
n=96 Participants
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
Peanut Placebo
n=50 Participants
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance.
|
|---|---|---|
|
Percentage of Participants That Withdrew From the Study
Terminated during Initial Dose Escalation
|
2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants That Withdrew From the Study
Terminated during Build-Up
|
4 percentage of participants
|
12 percentage of participants
|
|
Percentage of Participants That Withdrew From the Study
Terminated during Maintenance
|
8 percentage of participants
|
16 percentage of participants
|
|
Percentage of Participants That Withdrew From the Study
Terminated after Maintenance/Prior to OFC
|
1 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants That Withdrew From the Study
Terminated during Avoidance
|
11 percentage of participants
|
14 percentage of participants
|
|
Percentage of Participants That Withdrew From the Study
Terminated after Avoidance/Prior to OFC
|
0 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants That Withdrew From the Study
Terminated after Tolerance Assessment
|
3 percentage of participants
|
2 percentage of participants
|
Adverse Events
Peanut Oral Immunotherapy (OIT)
Serious events: 3 serious events
Other events: 96 other events
Deaths: 0 deaths
Peanut Placebo
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peanut Oral Immunotherapy (OIT)
n=96 participants at risk
Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
|
Peanut Placebo
n=50 participants at risk
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract was derived from oat flour source material.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/96 • 162 weeks
|
4.0%
2/50 • Number of events 2 • 162 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/96 • 162 weeks
|
2.0%
1/50 • Number of events 1 • 162 weeks
|
|
Infections and infestations
Pyelonephritis
|
1.0%
1/96 • Number of events 1 • 162 weeks
|
0.00%
0/50 • 162 weeks
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
1/96 • Number of events 1 • 162 weeks
|
0.00%
0/50 • 162 weeks
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/96 • 162 weeks
|
2.0%
1/50 • Number of events 1 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/96 • Number of events 1 • 162 weeks
|
2.0%
1/50 • Number of events 1 • 162 weeks
|
Other adverse events
| Measure |
Peanut Oral Immunotherapy (OIT)
n=96 participants at risk
Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
|
Peanut Placebo
n=50 participants at risk
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract was derived from oat flour source material.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
4/96 • Number of events 9 • 162 weeks
|
6.0%
3/50 • Number of events 3 • 162 weeks
|
|
Eye disorders
Conjunctivitis
|
6.2%
6/96 • Number of events 8 • 162 weeks
|
10.0%
5/50 • Number of events 9 • 162 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.8%
18/96 • Number of events 48 • 162 weeks
|
8.0%
4/50 • Number of events 6 • 162 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
30.2%
29/96 • Number of events 105 • 162 weeks
|
10.0%
5/50 • Number of events 18 • 162 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.4%
10/96 • Number of events 26 • 162 weeks
|
4.0%
2/50 • Number of events 4 • 162 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.3%
8/96 • Number of events 8 • 162 weeks
|
14.0%
7/50 • Number of events 8 • 162 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
20/96 • Number of events 26 • 162 weeks
|
24.0%
12/50 • Number of events 20 • 162 weeks
|
|
Gastrointestinal disorders
Gastritis
|
13.5%
13/96 • Number of events 19 • 162 weeks
|
10.0%
5/50 • Number of events 15 • 162 weeks
|
|
Gastrointestinal disorders
Lip pruritus
|
5.2%
5/96 • Number of events 10 • 162 weeks
|
0.00%
0/50 • 162 weeks
|
|
Gastrointestinal disorders
Vomiting
|
46.9%
45/96 • Number of events 80 • 162 weeks
|
38.0%
19/50 • Number of events 32 • 162 weeks
|
|
General disorders
Influenza like illness
|
20.8%
20/96 • Number of events 78 • 162 weeks
|
16.0%
8/50 • Number of events 27 • 162 weeks
|
|
General disorders
Pyrexia
|
67.7%
65/96 • Number of events 190 • 162 weeks
|
58.0%
29/50 • Number of events 108 • 162 weeks
|
|
Immune system disorders
Allergy to animal
|
6.2%
6/96 • Number of events 15 • 162 weeks
|
6.0%
3/50 • Number of events 6 • 162 weeks
|
|
Immune system disorders
Food allergy
|
88.5%
85/96 • Number of events 135 • 162 weeks
|
86.0%
43/50 • Number of events 72 • 162 weeks
|
|
Immune system disorders
Hypersensitivity
|
40.6%
39/96 • Number of events 77 • 162 weeks
|
30.0%
15/50 • Number of events 25 • 162 weeks
|
|
Immune system disorders
Type I hypersensitivity
|
78.1%
75/96 • Number of events 1047 • 162 weeks
|
62.0%
31/50 • Number of events 152 • 162 weeks
|
|
Infections and infestations
Bronchitis
|
3.1%
3/96 • Number of events 3 • 162 weeks
|
6.0%
3/50 • Number of events 4 • 162 weeks
|
|
Infections and infestations
Croup infectious
|
14.6%
14/96 • Number of events 27 • 162 weeks
|
10.0%
5/50 • Number of events 7 • 162 weeks
|
|
Infections and infestations
Ear infection
|
12.5%
12/96 • Number of events 14 • 162 weeks
|
14.0%
7/50 • Number of events 8 • 162 weeks
|
|
Infections and infestations
Gastroenteritis
|
36.5%
35/96 • Number of events 48 • 162 weeks
|
24.0%
12/50 • Number of events 19 • 162 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
19.8%
19/96 • Number of events 27 • 162 weeks
|
18.0%
9/50 • Number of events 9 • 162 weeks
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
6.2%
6/96 • Number of events 6 • 162 weeks
|
4.0%
2/50 • Number of events 2 • 162 weeks
|
|
Infections and infestations
Impetigo
|
5.2%
5/96 • Number of events 5 • 162 weeks
|
0.00%
0/50 • 162 weeks
|
|
Infections and infestations
Influenza
|
8.3%
8/96 • Number of events 9 • 162 weeks
|
14.0%
7/50 • Number of events 7 • 162 weeks
|
|
Infections and infestations
Molluscum contagiosum
|
5.2%
5/96 • Number of events 5 • 162 weeks
|
6.0%
3/50 • Number of events 3 • 162 weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
8/96 • Number of events 13 • 162 weeks
|
4.0%
2/50 • Number of events 8 • 162 weeks
|
|
Infections and infestations
Otitis media
|
24.0%
23/96 • Number of events 38 • 162 weeks
|
30.0%
15/50 • Number of events 21 • 162 weeks
|
|
Infections and infestations
Otitis media acute
|
5.2%
5/96 • Number of events 5 • 162 weeks
|
4.0%
2/50 • Number of events 2 • 162 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
21.9%
21/96 • Number of events 28 • 162 weeks
|
6.0%
3/50 • Number of events 8 • 162 weeks
|
|
Infections and infestations
Pneumonia
|
9.4%
9/96 • Number of events 10 • 162 weeks
|
10.0%
5/50 • Number of events 6 • 162 weeks
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
1/96 • Number of events 1 • 162 weeks
|
8.0%
4/50 • Number of events 4 • 162 weeks
|
|
Infections and infestations
Sinusitis
|
13.5%
13/96 • Number of events 19 • 162 weeks
|
10.0%
5/50 • Number of events 16 • 162 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
35.4%
34/96 • Number of events 73 • 162 weeks
|
36.0%
18/50 • Number of events 42 • 162 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/96 • 162 weeks
|
8.0%
4/50 • Number of events 4 • 162 weeks
|
|
Infections and infestations
Viral infection
|
34.4%
33/96 • Number of events 67 • 162 weeks
|
24.0%
12/50 • Number of events 16 • 162 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
27.1%
26/96 • Number of events 42 • 162 weeks
|
16.0%
8/50 • Number of events 14 • 162 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.0%
1/96 • Number of events 2 • 162 weeks
|
6.0%
3/50 • Number of events 3 • 162 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
5.2%
5/96 • Number of events 6 • 162 weeks
|
4.0%
2/50 • Number of events 2 • 162 weeks
|
|
Nervous system disorders
Headache
|
8.3%
8/96 • Number of events 11 • 162 weeks
|
2.0%
1/50 • Number of events 1 • 162 weeks
|
|
Psychiatric disorders
Agitation
|
9.4%
9/96 • Number of events 10 • 162 weeks
|
6.0%
3/50 • Number of events 3 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
12.5%
12/96 • Number of events 17 • 162 weeks
|
16.0%
8/50 • Number of events 11 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
48/96 • Number of events 133 • 162 weeks
|
46.0%
23/50 • Number of events 49 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.9%
22/96 • Number of events 39 • 162 weeks
|
18.0%
9/50 • Number of events 18 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
20.8%
20/96 • Number of events 33 • 162 weeks
|
12.0%
6/50 • Number of events 17 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.4%
9/96 • Number of events 16 • 162 weeks
|
4.0%
2/50 • Number of events 2 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.3%
7/96 • Number of events 9 • 162 weeks
|
0.00%
0/50 • 162 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
17.7%
17/96 • Number of events 33 • 162 weeks
|
30.0%
15/50 • Number of events 22 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
9.4%
9/96 • Number of events 13 • 162 weeks
|
14.0%
7/50 • Number of events 8 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
28.1%
27/96 • Number of events 65 • 162 weeks
|
24.0%
12/50 • Number of events 16 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.2%
5/96 • Number of events 8 • 162 weeks
|
10.0%
5/50 • Number of events 5 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.6%
15/96 • Number of events 39 • 162 weeks
|
20.0%
10/50 • Number of events 17 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
24/96 • Number of events 33 • 162 weeks
|
22.0%
11/50 • Number of events 24 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.3%
7/96 • Number of events 9 • 162 weeks
|
2.0%
1/50 • Number of events 1 • 162 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
24/96 • Number of events 65 • 162 weeks
|
32.0%
16/50 • Number of events 29 • 162 weeks
|
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