Trial Outcomes & Findings for ARTEMIS Peanut Allergy In Children (NCT NCT03201003)
NCT ID: NCT03201003
Last Updated: 2021-08-03
Results Overview
The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
Approximately 9 months
Results posted on
2021-08-03
Participant Flow
Participant milestones
| Measure |
AR101
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
43
|
|
Overall Study
COMPLETED
|
106
|
40
|
|
Overall Study
NOT COMPLETED
|
26
|
3
|
Reasons for withdrawal
| Measure |
AR101
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
1
|
|
Overall Study
Other reasons
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
ARTEMIS Peanut Allergy In Children
Baseline characteristics by cohort
| Measure |
AR101
n=132 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 Participants
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Children (4-11 years)
|
97 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
35 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
8 participants
n=99 Participants
|
3 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Region of Enrollment
Ireland
|
20 participants
n=99 Participants
|
6 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
46 participants
n=99 Participants
|
13 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Region of Enrollment
France
|
12 participants
n=99 Participants
|
5 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=99 Participants
|
7 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=99 Participants
|
6 participants
n=107 Participants
|
26 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 9 monthsThe proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Outcome measures
| Measure |
AR101
n=132 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 Participants
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge.
|
77 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 9 monthsThe proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Outcome measures
| Measure |
AR101
n=132 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 Participants
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge
|
90 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Approximately 9 monthsThe proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Outcome measures
| Measure |
AR101
n=132 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 Participants
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge.
|
97 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Approximately 9 monthsThe maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower)
Outcome measures
| Measure |
AR101
n=132 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 Participants
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
None
|
47 Participants
|
0 Participants
|
|
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
Mild
|
55 Participants
|
16 Participants
|
|
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
Moderate
|
24 Participants
|
20 Participants
|
|
Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge
Severe or higher
|
6 Participants
|
7 Participants
|
Adverse Events
AR101
Serious events: 1 serious events
Other events: 130 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR101
n=132 participants at risk
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 participants at risk
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.76%
1/132 • Number of events 1 • Approximately 9 months
|
0.00%
0/43 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/132 • Approximately 9 months
|
2.3%
1/43 • Number of events 1 • Approximately 9 months
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/132 • Approximately 9 months
|
2.3%
1/43 • Number of events 1 • Approximately 9 months
|
Other adverse events
| Measure |
AR101
n=132 participants at risk
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=43 participants at risk
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase.
|
|---|---|---|
|
Vascular disorders
Flushing
|
11.4%
15/132 • Number of events 42 • Approximately 9 months
|
2.3%
1/43 • Number of events 3 • Approximately 9 months
|
|
Immune system disorders
Systemic allergic reaction
|
12.1%
16/132 • Number of events 22 • Approximately 9 months
|
2.3%
1/43 • Number of events 2 • Approximately 9 months
|
|
Immune system disorders
Seasonal allergy
|
7.6%
10/132 • Number of events 20 • Approximately 9 months
|
4.7%
2/43 • Number of events 2 • Approximately 9 months
|
|
General disorders
Pyrexia
|
22.0%
29/132 • Number of events 41 • Approximately 9 months
|
32.6%
14/43 • Number of events 19 • Approximately 9 months
|
|
General disorders
Fatigue
|
9.8%
13/132 • Number of events 36 • Approximately 9 months
|
11.6%
5/43 • Number of events 5 • Approximately 9 months
|
|
General disorders
Malaise
|
6.1%
8/132 • Number of events 12 • Approximately 9 months
|
7.0%
3/43 • Number of events 3 • Approximately 9 months
|
|
General disorders
Chest discomfort
|
5.3%
7/132 • Number of events 15 • Approximately 9 months
|
2.3%
1/43 • Number of events 1 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
43.2%
57/132 • Number of events 659 • Approximately 9 months
|
18.6%
8/43 • Number of events 25 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
32.6%
43/132 • Number of events 157 • Approximately 9 months
|
16.3%
7/43 • Number of events 24 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
66/132 • Number of events 166 • Approximately 9 months
|
55.8%
24/43 • Number of events 53 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.8%
34/132 • Number of events 89 • Approximately 9 months
|
23.3%
10/43 • Number of events 22 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.4%
23/132 • Number of events 63 • Approximately 9 months
|
18.6%
8/43 • Number of events 12 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.4%
15/132 • Number of events 40 • Approximately 9 months
|
7.0%
3/43 • Number of events 11 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
22/132 • Number of events 45 • Approximately 9 months
|
7.0%
3/43 • Number of events 8 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
7.6%
10/132 • Number of events 31 • Approximately 9 months
|
2.3%
1/43 • Number of events 8 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
8.3%
11/132 • Number of events 19 • Approximately 9 months
|
7.0%
3/43 • Number of events 3 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
28.0%
37/132 • Number of events 99 • Approximately 9 months
|
27.9%
12/43 • Number of events 18 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
5.3%
7/132 • Number of events 37 • Approximately 9 months
|
4.7%
2/43 • Number of events 3 • Approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.3%
7/132 • Number of events 12 • Approximately 9 months
|
7.0%
3/43 • Number of events 7 • Approximately 9 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.1%
8/132 • Number of events 10 • Approximately 9 months
|
2.3%
1/43 • Number of events 1 • Approximately 9 months
|
|
Nervous system disorders
Headache
|
34.8%
46/132 • Number of events 128 • Approximately 9 months
|
44.2%
19/43 • Number of events 65 • Approximately 9 months
|
|
Nervous system disorders
Dizziness
|
3.0%
4/132 • Number of events 4 • Approximately 9 months
|
7.0%
3/43 • Number of events 3 • Approximately 9 months
|
|
Eye disorders
Eye pruritus
|
18.2%
24/132 • Number of events 37 • Approximately 9 months
|
18.6%
8/43 • Number of events 12 • Approximately 9 months
|
|
Eye disorders
Eye swelling
|
8.3%
11/132 • Number of events 18 • Approximately 9 months
|
7.0%
3/43 • Number of events 7 • Approximately 9 months
|
|
Ear and labyrinth disorders
Ear pain
|
10.6%
14/132 • Number of events 21 • Approximately 9 months
|
0.00%
0/43 • Approximately 9 months
|
|
Ear and labyrinth disorders
Motion sickness
|
3.0%
4/132 • Number of events 5 • Approximately 9 months
|
7.0%
3/43 • Number of events 4 • Approximately 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
88/132 • Number of events 835 • Approximately 9 months
|
44.2%
19/43 • Number of events 126 • Approximately 9 months
|
|
Gastrointestinal disorders
Nausea
|
43.9%
58/132 • Number of events 437 • Approximately 9 months
|
25.6%
11/43 • Number of events 31 • Approximately 9 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
39.4%
52/132 • Number of events 961 • Approximately 9 months
|
20.9%
9/43 • Number of events 49 • Approximately 9 months
|
|
Gastrointestinal disorders
Vomiting
|
40.2%
53/132 • Number of events 120 • Approximately 9 months
|
23.3%
10/43 • Number of events 17 • Approximately 9 months
|
|
Gastrointestinal disorders
Oral pruritus
|
21.2%
28/132 • Number of events 236 • Approximately 9 months
|
2.3%
1/43 • Number of events 1 • Approximately 9 months
|
|
Gastrointestinal disorders
Lip swelling
|
15.2%
20/132 • Number of events 112 • Approximately 9 months
|
9.3%
4/43 • Number of events 6 • Approximately 9 months
|
|
Gastrointestinal disorders
Lip pruritus
|
12.1%
16/132 • Number of events 97 • Approximately 9 months
|
4.7%
2/43 • Number of events 2 • Approximately 9 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.9%
17/132 • Number of events 120 • Approximately 9 months
|
4.7%
2/43 • Number of events 3 • Approximately 9 months
|
|
Gastrointestinal disorders
Tongue pruritus
|
9.1%
12/132 • Number of events 133 • Approximately 9 months
|
11.6%
5/43 • Number of events 11 • Approximately 9 months
|
|
Gastrointestinal disorders
Lip oedema
|
5.3%
7/132 • Number of events 20 • Approximately 9 months
|
2.3%
1/43 • Number of events 2 • Approximately 9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
16/132 • Number of events 26 • Approximately 9 months
|
18.6%
8/43 • Number of events 19 • Approximately 9 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.6%
14/132 • Number of events 44 • Approximately 9 months
|
11.6%
5/43 • Number of events 6 • Approximately 9 months
|
|
Gastrointestinal disorders
Lip pain
|
5.3%
7/132 • Number of events 21 • Approximately 9 months
|
0.00%
0/43 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.8%
67/132 • Number of events 300 • Approximately 9 months
|
32.6%
14/43 • Number of events 62 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
36.4%
48/132 • Number of events 156 • Approximately 9 months
|
20.9%
9/43 • Number of events 27 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.8%
34/132 • Number of events 69 • Approximately 9 months
|
11.6%
5/43 • Number of events 5 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.9%
21/132 • Number of events 38 • Approximately 9 months
|
18.6%
8/43 • Number of events 18 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
9.8%
13/132 • Number of events 87 • Approximately 9 months
|
9.3%
4/43 • Number of events 7 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.1%
12/132 • Number of events 25 • Approximately 9 months
|
25.6%
11/43 • Number of events 18 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
6/132 • Number of events 8 • Approximately 9 months
|
9.3%
4/43 • Number of events 5 • Approximately 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.3%
3/132 • Number of events 3 • Approximately 9 months
|
9.3%
4/43 • Number of events 5 • Approximately 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
11/132 • Number of events 15 • Approximately 9 months
|
2.3%
1/43 • Number of events 1 • Approximately 9 months
|
|
Infections and infestations
Conjunctivitis
|
11.4%
15/132 • Number of events 31 • Approximately 9 months
|
11.6%
5/43 • Number of events 25 • Approximately 9 months
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
44/132 • Number of events 77 • Approximately 9 months
|
27.9%
12/43 • Number of events 21 • Approximately 9 months
|
|
Infections and infestations
Rhinitis
|
15.2%
20/132 • Number of events 51 • Approximately 9 months
|
16.3%
7/43 • Number of events 17 • Approximately 9 months
|
|
Infections and infestations
Viral infection
|
13.6%
18/132 • Number of events 24 • Approximately 9 months
|
16.3%
7/43 • Number of events 10 • Approximately 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
17/132 • Number of events 21 • Approximately 9 months
|
25.6%
11/43 • Number of events 12 • Approximately 9 months
|
|
Infections and infestations
Gastroenteritis
|
9.1%
12/132 • Number of events 13 • Approximately 9 months
|
11.6%
5/43 • Number of events 6 • Approximately 9 months
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
7/132 • Number of events 8 • Approximately 9 months
|
0.00%
0/43 • Approximately 9 months
|
|
Infections and infestations
Influenza
|
3.0%
4/132 • Number of events 4 • Approximately 9 months
|
7.0%
3/43 • Number of events 3 • Approximately 9 months
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
3/132 • Number of events 4 • Approximately 9 months
|
7.0%
3/43 • Number of events 5 • Approximately 9 months
|
Additional Information
Director of Regulatory Affairs
Aimmune Therapeutics, Inc.
Phone: 650-409-5164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee * Institutions cannot publish until the multi-center sponsor publication is published * Or, institutions cannot publish until 18 months after study completion * And Sponsor review of any publications is required prior to any institution publications according to contractual agreements
- Publication restrictions are in place
Restriction type: OTHER