Trial Outcomes & Findings for Oral Immunotherapy for Wheat Allergy (NCT NCT01980992)
NCT ID: NCT01980992
Last Updated: 2020-08-14
Results Overview
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
1 Year
Results posted on
2020-08-14
Participant Flow
Enrollment began November 2013 and was completed in November 2014
Participant milestones
| Measure |
Placebo Then High Dose Group
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
|---|---|---|
|
52 Weeks Blinded Study Treatment
STARTED
|
23
|
23
|
|
52 Weeks Blinded Study Treatment
COMPLETED
|
21
|
19
|
|
52 Weeks Blinded Study Treatment
NOT COMPLETED
|
2
|
4
|
|
52 Weeks Open Label Active Wheat OIT
STARTED
|
21
|
19
|
|
52 Weeks Open Label Active Wheat OIT
COMPLETED
|
18
|
18
|
|
52 Weeks Open Label Active Wheat OIT
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo Then High Dose Group
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
|---|---|---|
|
52 Weeks Blinded Study Treatment
Dosing Symptoms
|
0
|
3
|
|
52 Weeks Blinded Study Treatment
Withdrawal by Subject
|
1
|
1
|
|
52 Weeks Blinded Study Treatment
Non-compliance
|
1
|
0
|
|
52 Weeks Open Label Active Wheat OIT
Dosing Symptoms
|
2
|
0
|
|
52 Weeks Open Label Active Wheat OIT
Non-compliance
|
1
|
0
|
|
52 Weeks Open Label Active Wheat OIT
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Oral Immunotherapy for Wheat Allergy
Baseline characteristics by cohort
| Measure |
Placebo Then High Dose Group
n=23 Participants
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
n=23 Participants
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.7 years
n=5 Participants
|
8.6 years
n=7 Participants
|
8.7 years
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
|
Wheat IgE
|
86.8 kUA/L
n=5 Participants
|
94.1 kUA/L
n=7 Participants
|
88.4 kUA/L
n=5 Participants
|
|
Wheat IgG4
|
4.6 mgA/L
n=5 Participants
|
2.9 mgA/L
n=7 Participants
|
4.2 mgA/L
n=5 Participants
|
|
Wheat Skin Prick Test
|
6.8 mm
STANDARD_DEVIATION 2.8 • n=5 Participants
|
5.3 mm
STANDARD_DEVIATION 3.4 • n=7 Participants
|
6.1 mm
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Wheat OFC Dose at First Symptom
|
13.0 mg protein
n=5 Participants
|
43.0 mg protein
n=7 Participants
|
13.0 mg protein
n=5 Participants
|
|
Wheat OFC Successfully Consumed Dose
|
43.0 mg protein
n=5 Participants
|
43.0 mg protein
n=7 Participants
|
43.0 mg protein
n=5 Participants
|
|
Maximum Initial Escalation Day Dose
|
12.0 mg powder
n=5 Participants
|
12.0 mg powder
n=7 Participants
|
12.0 mg powder
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: All randomized participants were included.
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
Outcome measures
| Measure |
Placebo
n=23 Participants
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
n=23 Participants
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Wheat OIT After 1 Year
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
|
0 Participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 to 10 weeks after passing the 2 Year OFCPopulation: This is not applicable for the Placebo Crossover subjects as they did not complete at 2 Year Tolerance OFC per the protocol.
The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.
Outcome measures
| Measure |
Placebo
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
n=23 Participants
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Wheat OIT After 1 Year
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 44 WeeksThe number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.
Outcome measures
| Measure |
Placebo
n=23 Participants
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
n=23 Participants
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Wheat OIT After 1 Year
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT
|
21 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Two Placebo subjects did not crossover. This outcome measure is only for the Placebo crossover group.
The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).
Outcome measures
| Measure |
Placebo
n=21 Participants
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Wheat OIT After 1 Year
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group
|
14 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year and 2 YearsPopulation: Data was available for 22 participants in the Wheat OIT group and 21 participants for the Placebo Crossover group at the end of the study.
Outcome measures
| Measure |
Placebo
n=23 Participants
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT
n=23 Participants
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Wheat OIT After 1 Year
n=22 Participants
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
n=21 Participants
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
Incidence of All Serious Adverse Events During the Study.
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Wheat OIT Before 1 Year
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Before 1 Year
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Wheat OIT After 1 Year
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Crossover
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wheat OIT Before 1 Year
n=23 participants at risk
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Before 1 Year
n=23 participants at risk
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT After 1 Year
n=22 participants at risk
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
n=21 participants at risk
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/23 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/21 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/23 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/21 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/23 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/21 • 2 years
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Wheat OIT Before 1 Year
n=23 participants at risk
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Before 1 Year
n=23 participants at risk
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
Wheat OIT After 1 Year
n=22 participants at risk
2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
|
Placebo Crossover
n=21 participants at risk
52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
4.8%
1/21 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.7%
2/23 • Number of events 4 • 2 years
|
21.7%
5/23 • Number of events 9 • 2 years
|
0.00%
0/22 • 2 years
|
23.8%
5/21 • Number of events 10 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.7%
2/23 • Number of events 4 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
1/23 • Number of events 4 • 2 years
|
4.3%
1/23 • Number of events 16 • 2 years
|
4.5%
1/22 • Number of events 8 • 2 years
|
0.00%
0/21 • 2 years
|
|
General disorders
Nausea
|
8.7%
2/23 • Number of events 3 • 2 years
|
4.3%
1/23 • Number of events 2 • 2 years
|
9.1%
2/22 • Number of events 6 • 2 years
|
0.00%
0/21 • 2 years
|
|
General disorders
Vomiting
|
34.8%
8/23 • Number of events 25 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 5 • 2 years
|
33.3%
7/21 • Number of events 20 • 2 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
17.4%
4/23 • Number of events 4 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
General disorders
Rhinitis allergic
|
4.3%
1/23 • Number of events 1 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.7%
2/23 • Number of events 8 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Eye disorders
Eye pruritus
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
69.6%
16/23 • Number of events 484 • 2 years
|
26.1%
6/23 • Number of events 28 • 2 years
|
27.3%
6/22 • Number of events 74 • 2 years
|
61.9%
13/21 • Number of events 146 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
2/23 • Number of events 3 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • Number of events 20 • 2 years
|
8.7%
2/23 • Number of events 6 • 2 years
|
4.5%
1/22 • Number of events 5 • 2 years
|
9.5%
2/21 • Number of events 11 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 8 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
14.3%
3/21 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Gastrontestinal disorder
|
73.9%
17/23 • Number of events 172 • 2 years
|
47.8%
11/23 • Number of events 57 • 2 years
|
22.7%
5/22 • Number of events 14 • 2 years
|
76.2%
16/21 • Number of events 153 • 2 years
|
|
Gastrointestinal disorders
Gastrooescophageal refluz disease
|
8.7%
2/23 • Number of events 8 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
nausea
|
4.3%
1/23 • Number of events 1 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/21 • 2 years
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Gastrointestinal disorders
Saliva altered
|
4.3%
1/23 • Number of events 17 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Number of events 5 • 2 years
|
17.4%
4/23 • Number of events 5 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
General disorders
Chest discomfort
|
17.4%
4/23 • Number of events 85 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
19.0%
4/21 • Number of events 13 • 2 years
|
|
General disorders
Chest pain
|
4.3%
1/23 • Number of events 5 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
General disorders
Influenza like illness
|
17.4%
4/23 • Number of events 5 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
13.6%
3/22 • Number of events 4 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
General disorders
Malaise
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
General disorders
Pyrexia
|
26.1%
6/23 • Number of events 6 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
13.6%
3/22 • Number of events 4 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Immune system disorders
Hypersensitivity
|
13.0%
3/23 • Number of events 3 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/23 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 3 • 2 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Infections and infestations
Croup infectious
|
0.00%
0/23 • 2 years
|
4.3%
1/23 • Number of events 3 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 3 • 2 years
|
|
Infections and infestations
Ear infection
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
14.3%
3/21 • Number of events 3 • 2 years
|
|
Infections and infestations
Gastroenteritis viral
|
4.3%
1/23 • Number of events 1 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/23 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Infections and infestations
Pharyngitis streptococcal
|
13.0%
3/23 • Number of events 3 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Infections and infestations
Sinusitis
|
13.0%
3/23 • Number of events 3 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Infections and infestations
upper respiratory tract infection
|
21.7%
5/23 • Number of events 11 • 2 years
|
30.4%
7/23 • Number of events 10 • 2 years
|
18.2%
4/22 • Number of events 4 • 2 years
|
47.6%
10/21 • Number of events 17 • 2 years
|
|
Infections and infestations
Viral infection
|
8.7%
2/23 • Number of events 2 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
0.00%
0/21 • 2 years
|
|
Infections and infestations
Viral upper respiratory tract infection
|
17.4%
4/23 • Number of events 4 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
14.3%
3/21 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 4 • 2 years
|
13.0%
3/23 • Number of events 3 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/21 • 2 years
|
|
Psychiatric disorders
nervousness
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
13.0%
3/23 • Number of events 3 • 2 years
|
13.0%
3/23 • Number of events 7 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
65.2%
15/23 • Number of events 55 • 2 years
|
21.7%
5/23 • Number of events 12 • 2 years
|
18.2%
4/22 • Number of events 7 • 2 years
|
38.1%
8/21 • Number of events 32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.0%
3/23 • Number of events 10 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
9.5%
2/21 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
47.8%
11/23 • Number of events 126 • 2 years
|
8.7%
2/23 • Number of events 2 • 2 years
|
9.1%
2/22 • Number of events 12 • 2 years
|
28.6%
6/21 • Number of events 31 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
69.6%
16/23 • Number of events 304 • 2 years
|
30.4%
7/23 • Number of events 10 • 2 years
|
27.3%
6/22 • Number of events 27 • 2 years
|
81.0%
17/21 • Number of events 200 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhimorrhoea
|
69.6%
16/23 • Number of events 157 • 2 years
|
34.8%
8/23 • Number of events 16 • 2 years
|
18.2%
4/22 • Number of events 14 • 2 years
|
52.4%
11/21 • Number of events 45 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
8.7%
2/23 • Number of events 3 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
4.8%
1/21 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
dermatitis atopic
|
8.7%
2/23 • Number of events 2 • 2 years
|
0.00%
0/23 • 2 years
|
0.00%
0/22 • 2 years
|
0.00%
0/21 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
4.5%
1/22 • Number of events 4 • 2 years
|
0.00%
0/21 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
52.2%
12/23 • Number of events 121 • 2 years
|
56.5%
13/23 • Number of events 311 • 2 years
|
4.5%
1/22 • Number of events 8 • 2 years
|
61.9%
13/21 • Number of events 347 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/23 • 2 years
|
0.00%
0/23 • 2 years
|
9.1%
2/22 • Number of events 3 • 2 years
|
4.8%
1/21 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • Number of events 2 • 2 years
|
4.3%
1/23 • Number of events 1 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
9.5%
2/21 • Number of events 3 • 2 years
|
|
Vascular disorders
Flashing
|
26.1%
6/23 • Number of events 40 • 2 years
|
30.4%
7/23 • Number of events 9 • 2 years
|
4.5%
1/22 • Number of events 2 • 2 years
|
47.6%
10/21 • Number of events 26 • 2 years
|
Additional Information
Dr. Hugh A. Sampson
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9426
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place