Trial Outcomes & Findings for Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (NCT NCT03211247)
NCT ID: NCT03211247
Last Updated: 2024-12-16
Results Overview
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
414 participants
Primary outcome timeframe
Month 12
Results posted on
2024-12-16
Participant Flow
This Phase III was conducted in participants aged 1 to 3 years with peanut-allergy at 51 centers in Australia, Canada, Europe, and the United States of America. The entire duration of study was approximately 62 weeks (6-week: screening period; 12-month treatment period; and 4-week follow-up period).
In Part A, a total of 51 participants were randomized either in the placebo arm or in the 2 active arms (Viaskin Peanut (DBV712) 100 mcg or 250 mcg) in a 1:2:2 ratio. In Part B, a total of 362 participants were randomized in a 2:1 ratio to receive Viaskin Peanut (DBV712) 250 mcg or placebo.
Participant milestones
| Measure |
Part B Viaskin Peanut 250 mcg
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
244
|
118
|
21
|
20
|
10
|
|
Overall Study
COMPLETED
|
208
|
99
|
17
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
36
|
19
|
4
|
4
|
1
|
Reasons for withdrawal
| Measure |
Part B Viaskin Peanut 250 mcg
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Non-compliance with study drug
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant withdrawal by Parent or Caregiver
|
18
|
13
|
2
|
1
|
0
|
|
Overall Study
Participant did not want to complete oral food challenge
|
5
|
2
|
1
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Baseline characteristics by cohort
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 Participants
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
244 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
413 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
130 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
283 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
159 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
268 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
41 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
69 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
35 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not collected
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The FAS comprised of all participants who were randomized in the study.
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
Outcome measures
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 Participants
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Percentage of Treatment Responders at Month 12
|
67.0 Percentage of participants
Interval 60.93 to 73.01
|
33.5 Percentage of participants
Interval 24.84 to 42.24
|
52.4 Percentage of participants
Interval 29.8 to 74.3
|
70.0 Percentage of participants
Interval 45.7 to 88.1
|
60.0 Percentage of participants
Interval 26.2 to 74.3
|
SECONDARY outcome
Timeframe: Month 12Population: The FAS comprised of all participants who were randomized in the study.
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.
Outcome measures
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 Participants
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model
|
1010.31 milligram (mg)
Interval 842.18 to 1212.01
|
322.57 milligram (mg)
Interval 248.37 to 418.94
|
788.74 milligram (mg)
Interval 220.2 to 2825.24
|
1155.90 milligram (mg)
Interval 367.53 to 3635.38
|
1153.47 milligram (mg)
Interval 474.34 to 2804.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 12Population: The FAS comprised of all participants who were randomized in the study.
The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.
Outcome measures
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 Participants
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Change From Baseline in CRD of Peanut Protein to Month 12
|
1300.0 mg
Interval 140.0 to 3000.0
|
0.0 mg
Interval 0.0 to 1000.0
|
540.0 mg
Interval 0.0 to 2930.0
|
1250.0 mg
Interval 2.5 to 3000.0
|
1000.0 mg
Interval 300.0 to 2560.0
|
SECONDARY outcome
Timeframe: Month 12Population: The FAS comprised of all participants who were randomized in the study.
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.
Outcome measures
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 Participants
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
ED of Peanut Protein at Month 12 Using ANCOVA Model
|
659.36 mg
Interval 553.84 to 784.99
|
223.12 mg
Interval 173.4 to 287.09
|
526.31 mg
Interval 151.15 to 1832.58
|
730.38 mg
Interval 254.17 to 2098.83
|
760.60 mg
Interval 325.34 to 1778.17
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 12Population: The FAS comprised of all participants who were randomized in the study.
The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge.
Outcome measures
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=21 Participants
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Change From Baseline in ED of Peanut Protein to Month 12
|
900.0 mg
Interval 90.0 to 1700.0
|
0.0 mg
Interval 0.0 to 700.0
|
700.0 mg
Interval 0.0 to 1700.0
|
700.0 mg
Interval 0.0 to 1700.0
|
700.0 mg
Interval 200.0 to 1700.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 12Population: The FAS comprised of all participants who were randomized in the study. This outcome was measured on Part B subjects only. Therefore subjects from Part A are reported as zero in the outcome measure data table.
The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.
Outcome measures
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 Participants
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Baseline: Absent
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Baseline: Mild
|
7.0 Percentage of participants
|
7.6 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Baseline: Moderate
|
68.4 Percentage of participants
|
67.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Baseline: Severe
|
24.6 Percentage of participants
|
24.6 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Month 12: Absent
|
16.0 Percentage of participants
|
6.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Month 12: Mild
|
20.5 Percentage of participants
|
14.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Month 12: Moderate
|
51.0 Percentage of participants
|
51.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge
Month 12: Severe
|
12.5 Percentage of participants
|
28.6 Percentage of participants
|
—
|
—
|
—
|
Adverse Events
Part B Viaskin Peanut 250 mcg
Serious events: 21 serious events
Other events: 244 other events
Deaths: 0 deaths
Part B Placebo
Serious events: 3 serious events
Other events: 117 other events
Deaths: 0 deaths
Part A Viaskin Peanut 250 mcg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Part A Viaskin Peanut 100 mcg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Part A Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 participants at risk
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 participants at risk
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 participants at risk
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 participants at risk
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 participants at risk
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.5%
6/244 • Number of events 8 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.85%
1/118 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.82%
2/244 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Bronchitis
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Metapneumovirus Infection
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.41%
1/244 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Anaphylactic Reaction To Food
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
1.7%
2/118 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Anaphylaxis
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Food Allergy
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Medication Error
|
0.82%
2/244 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Blood and lymphatic system disorders
Aplasia Pure Red Cell
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Eye disorders
Periorbital Edema
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
Other adverse events
| Measure |
Part B Viaskin Peanut 250 mcg
n=244 participants at risk
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part B Placebo
n=118 participants at risk
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 250 mcg
n=21 participants at risk
Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Viaskin Peanut 100 mcg
n=20 participants at risk
Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
Part A Placebo
n=10 participants at risk
Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
|
|---|---|---|---|---|---|
|
General disorders
Application Site Erythema
|
98.0%
239/244 • Number of events 2182 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
90.7%
107/118 • Number of events 760 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
85.7%
18/21 • Number of events 21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
70.0%
14/20 • Number of events 15 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
60.0%
6/10 • Number of events 13 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Pruritus
|
94.7%
231/244 • Number of events 2925 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
61.0%
72/118 • Number of events 523 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
61.9%
13/21 • Number of events 15 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
55.0%
11/20 • Number of events 29 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Swelling
|
72.5%
177/244 • Number of events 2044 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
39.0%
46/118 • Number of events 278 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
33.3%
7/21 • Number of events 15 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Pyrexia
|
34.4%
84/244 • Number of events 150 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
42.4%
50/118 • Number of events 83 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
23.8%
5/21 • Number of events 8 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
30.0%
6/20 • Number of events 11 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Oedema
|
23.8%
58/244 • Number of events 504 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
17.8%
21/118 • Number of events 105 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Urticaria
|
27.9%
68/244 • Number of events 152 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
2.5%
3/118 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 8 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Vesicles
|
17.6%
43/244 • Number of events 179 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.3%
11/118 • Number of events 21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Papules
|
16.8%
41/244 • Number of events 63 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
7.6%
9/118 • Number of events 10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Eczema
|
13.9%
34/244 • Number of events 66 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
8.5%
10/118 • Number of events 12 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Erosion
|
13.1%
32/244 • Number of events 44 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.2%
5/118 • Number of events 6 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Discoloration
|
6.1%
15/244 • Number of events 16 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Food Allergy
|
13.5%
33/244 • Number of events 63 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
11.0%
13/118 • Number of events 20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
23.8%
5/21 • Number of events 5 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
4/20 • Number of events 6 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Hypersensitivity
|
9.8%
24/244 • Number of events 30 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.3%
11/118 • Number of events 22 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
23.8%
5/21 • Number of events 8 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Seasonal Allergy
|
11.5%
28/244 • Number of events 50 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
2.5%
3/118 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 5 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Anaphylactic Reaction
|
7.8%
19/244 • Number of events 25 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
1.7%
2/118 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Vomiting
|
23.0%
56/244 • Number of events 87 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
17.8%
21/118 • Number of events 34 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
33.3%
7/21 • Number of events 10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
4/20 • Number of events 8 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Diarrhea
|
9.0%
22/244 • Number of events 48 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.3%
11/118 • Number of events 21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Teething
|
4.9%
12/244 • Number of events 32 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.9%
7/118 • Number of events 12 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.7%
48/244 • Number of events 91 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.3%
24/118 • Number of events 42 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
30.0%
6/20 • Number of events 6 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
14.8%
36/244 • Number of events 66 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
19.5%
23/118 • Number of events 35 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
27/244 • Number of events 47 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.9%
7/118 • Number of events 16 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
25.0%
5/20 • Number of events 9 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
9.0%
22/244 • Number of events 28 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
8.5%
10/118 • Number of events 17 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.0%
22/244 • Number of events 35 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
7.6%
9/118 • Number of events 30 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
4/20 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.1%
15/244 • Number of events 21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
7.6%
9/118 • Number of events 14 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
34.8%
85/244 • Number of events 244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
37.3%
44/118 • Number of events 96 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
19.0%
4/21 • Number of events 14 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
4/20 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
50.0%
5/10 • Number of events 5 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
24.2%
59/244 • Number of events 125 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
25.4%
30/118 • Number of events 67 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
33.3%
7/21 • Number of events 22 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
30.0%
6/20 • Number of events 24 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.8%
36/244 • Number of events 49 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
12.7%
15/118 • Number of events 27 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.2%
37/244 • Number of events 55 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
11.9%
14/118 • Number of events 24 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
4/20 • Number of events 17 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
23/244 • Number of events 39 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
11.0%
13/118 • Number of events 13 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
3.7%
9/244 • Number of events 15 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.1%
6/118 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
42.2%
103/244 • Number of events 240 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
36.4%
43/118 • Number of events 129 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
61.9%
13/21 • Number of events 27 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
35.0%
7/20 • Number of events 20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
21.7%
53/244 • Number of events 102 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.3%
18/118 • Number of events 35 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 11 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 12 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Viral Infection
|
19.3%
47/244 • Number of events 76 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
16.1%
19/118 • Number of events 25 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Gastroenteritis
|
12.7%
31/244 • Number of events 41 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
11.0%
13/118 • Number of events 17 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
12.3%
30/244 • Number of events 46 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
11.0%
13/118 • Number of events 21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
23.8%
5/21 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Ear Infection
|
9.4%
23/244 • Number of events 42 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
12.7%
15/118 • Number of events 28 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
11.9%
29/244 • Number of events 54 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
6.8%
8/118 • Number of events 21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 5 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Gastroenteritis Viral
|
9.4%
23/244 • Number of events 24 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
2.5%
3/118 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Otitis Media
|
8.6%
21/244 • Number of events 33 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
3.4%
4/118 • Number of events 8 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
14.3%
3/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Croup Infectious
|
4.9%
12/244 • Number of events 13 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.2%
12/118 • Number of events 15 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Influenza
|
5.7%
14/244 • Number of events 14 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.2%
5/118 • Number of events 6 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Rhinitis
|
4.1%
10/244 • Number of events 11 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.9%
7/118 • Number of events 12 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Conjunctivitis
|
5.7%
14/244 • Number of events 15 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.85%
1/118 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Pneumonia
|
2.5%
6/244 • Number of events 6 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.1%
6/118 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Otitis Media Acute
|
0.41%
1/244 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.1%
6/118 • Number of events 7 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
4.1%
10/244 • Number of events 12 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.2%
12/118 • Number of events 18 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
2/20 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
11/244 • Number of events 16 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
3.4%
4/118 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Eye disorders
Eye Swelling
|
4.9%
12/244 • Number of events 16 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
3.4%
4/118 • Number of events 4 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Rash
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Hemorrage
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Pain
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Discomfort
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Application Site Dryness
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
General disorders
Irritability Postvaccinal
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
9.5%
2/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
20.0%
2/10 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Bullous Impetigo
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Coxsackie Viral Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Hand-Foot-And-Mouth Disease
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Herpangina
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Impetigo
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Localized Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Nail Bed Infection Bacterial
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Paronychia
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Perianal Streptococcal Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
15.0%
3/20 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Circumoral Oedema
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Idiopathic Urticaria
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Pruritis Generalized
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash Generalized
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Urticaria Contact
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Cough
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 3 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Oral Pruritus
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Chapped Lips
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Lip Pruritus
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 2 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Allergy To Arthropod Sting
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Atopy
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Mite Allergy
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Immune system disorders
Mycotic Allergy
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Extra Dose Administered
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Eye disorders
Erythema of Eyelid
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Ear and labyrinth disorders
Ear Pruritus
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Psychiatric disorders
Mood Swing
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Investigations
Eosinophil Count Increased
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Endocrine disorders
Growth Hormone Deficiency
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
5.0%
1/20 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
4.8%
1/21 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/10 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
|
Vascular disorders
Hematoma
|
0.00%
0/244 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/118 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/21 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
0.00%
0/20 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
10.0%
1/10 • Number of events 1 • The TEAEs were collected from Day 1 up to Month 12
The SAF comprised of all participants from the FAS who received at least 1 dose of IMP.
|
Additional Information
Pharis Mohideen, MD, Chief Medical Officer
DBV Technologies
Phone: 908-679-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER