Trial Outcomes & Findings for Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy (NCT NCT02237196)
NCT ID: NCT02237196
Last Updated: 2020-05-06
Results Overview
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
121 participants
Primary outcome timeframe
0 to 1 hour of the NAC at Week 104
Results posted on
2020-05-06
Participant Flow
Participants ages 18 years to 65 years with a history of moderate to severe allergic rhinitis caused by cat exposure were recruited from 9 clinical centers in the United States from March 3, 2015 to March 21, 2017.
Participant milestones
| Measure |
AMG 157+Cat Immunotherapy
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
30
|
28
|
|
Overall Study
COMPLETED
|
24
|
25
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
10
|
11
|
Reasons for withdrawal
| Measure |
AMG 157+Cat Immunotherapy
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
4
|
6
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
4
|
1
|
|
Overall Study
Site Error
|
1
|
2
|
0
|
2
|
Baseline Characteristics
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
Baseline characteristics by cohort
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
116 Participants
n=21 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
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 8.86 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 10.91 • n=4 Participants
|
30.5 years
STANDARD_DEVIATION 9.98 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 to 1 hour of the NAC at Week 104Population: Intent-to-treat
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The primary outcome compared the mean TNSS AUC from 0 to 1 hour after cat Nasal Allergen Challenge at 104 weeks by treatment group, using a longitudinal repeated measures model in the ITT sample. The model included fixed effects for treatment, time, and treatment by time interaction and included covariates for site, baseline TNSS AUC and Baseline Cat exposure (low vs high). The primary endpoint was assessed at week 104 using a contrast in least squares means between the following groups: AMG 157+Cat Immunotherapy and AMG 157 Placebo+Cat Immunotherapy.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Total Nasal Symptom Score (TNSS) Area Under the Curve (AUC)
|
2.46 Total Nasal Symptom Score * Hour
Interval 1.73 to 3.19
|
2.81 Total Nasal Symptom Score * Hour
Interval 2.13 to 3.49
|
3.66 Total Nasal Symptom Score * Hour
Interval 2.74 to 4.59
|
3.10 Total Nasal Symptom Score * Hour
Interval 2.11 to 4.1
|
SECONDARY outcome
Timeframe: 15 minutes after Time 0 of the skin prick titration test at: Baseline (Week 0) and Weeks 1, 4, 12, 26, 52, 78 and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat population was used in the reporting of secondary endpoints.
A dilution series of standardized cat allergen extracts were applied in duplicate on the participant's upper back. Wheal size was assessed 15 minutes after application.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Skin Prick Test Endpoint Titration
Baseline
|
45.11 mm
Interval 40.74 to 49.49
|
46.29 mm
Interval 38.88 to 53.69
|
45.01 mm
Interval 40.17 to 49.84
|
44.49 mm
Interval 38.25 to 50.73
|
|
Skin Prick Test Endpoint Titration
Week 1
|
45.92 mm
Interval 38.08 to 53.77
|
50.25 mm
Interval 42.22 to 58.28
|
43.33 mm
Interval 38.2 to 48.47
|
44.06 mm
Interval 38.31 to 49.82
|
|
Skin Prick Test Endpoint Titration
Week 4
|
39.24 mm
Interval 33.48 to 45.0
|
35.44 mm
Interval 29.39 to 41.49
|
44.01 mm
Interval 38.56 to 49.47
|
41.58 mm
Interval 35.59 to 47.57
|
|
Skin Prick Test Endpoint Titration
Week 12
|
30.12 mm
Interval 23.94 to 36.3
|
22.08 mm
Interval 16.33 to 27.84
|
45.85 mm
Interval 40.13 to 51.57
|
44.74 mm
Interval 39.09 to 50.38
|
|
Skin Prick Test Endpoint Titration
Week 26
|
21.96 mm
Interval 16.41 to 27.51
|
22.21 mm
Interval 14.45 to 29.98
|
43.93 mm
Interval 38.13 to 49.72
|
43.40 mm
Interval 37.27 to 49.53
|
|
Skin Prick Test Endpoint Titration
Week 52
|
21.34 mm
Interval 15.48 to 27.19
|
16.84 mm
Interval 12.69 to 20.99
|
34.92 mm
Interval 27.39 to 42.45
|
39.64 mm
Interval 30.51 to 48.77
|
|
Skin Prick Test Endpoint Titration
Week 78
|
22.21 mm
Interval 16.31 to 28.11
|
25.13 mm
Interval 20.18 to 30.08
|
32.28 mm
Interval 24.67 to 39.9
|
39.32 mm
Interval 30.39 to 48.25
|
|
Skin Prick Test Endpoint Titration
Week 104
|
26.88 mm
Interval 19.95 to 33.81
|
26.67 mm
Interval 21.68 to 31.66
|
39.82 mm
Interval 32.24 to 47.39
|
36.19 mm
Interval 29.33 to 43.06
|
SECONDARY outcome
Timeframe: 15 minutes after Time 0 of the intradermal test at: Baseline (Week 0) and Weeks 26, 52, and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Early Phase Response (EPR) is the response measured at 15 minutes after application.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Skin Early Phase Response (EPR) to Intradermal Testing
Baseline
|
16.05 mm
Interval 15.25 to 16.8
|
15.34 mm
Interval 14.42 to 16.26
|
15.98 mm
Interval 15.12 to 16.85
|
16.52 mm
Interval 15.66 to 17.37
|
|
Skin Early Phase Response (EPR) to Intradermal Testing
Week 26
|
11.21 mm
Interval 10.13 to 12.29
|
11.65 mm
Interval 10.86 to 12.43
|
14.15 mm
Interval 13.09 to 15.21
|
14.64 mm
Interval 13.21 to 16.07
|
|
Skin Early Phase Response (EPR) to Intradermal Testing
Week 52
|
10.65 mm
Interval 9.53 to 11.78
|
10.69 mm
Interval 9.72 to 11.67
|
13.35 mm
Interval 12.33 to 14.36
|
14.21 mm
Interval 12.4 to 16.03
|
|
Skin Early Phase Response (EPR) to Intradermal Testing
Week 104
|
11.04 mm
Interval 9.8 to 12.28
|
12.09 mm
Interval 10.8 to 13.38
|
12.63 mm
Interval 11.55 to 13.7
|
13.21 mm
Interval 11.6 to 14.82
|
SECONDARY outcome
Timeframe: 6 hours status post cat allergen challenge at: Baseline (Time 0) and Weeks 26, 52 and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
Concentrations of standardized cat hair extract were applied intradermally to the forearm. Wheal size was measured 15 minutes and 6 hours after application. The Late Phase Response (LPR) is the response measured at 6 hours after application.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=29 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=28 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=27 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=27 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Skin Late Phase Response (LPR) to Intradermal Testing
Baseline
|
32.62 mm
Interval 26.62 to 38.62
|
23.41 mm
Interval 17.23 to 29.59
|
27.22 mm
Interval 19.33 to 35.11
|
34.65 mm
Interval 27.27 to 42.03
|
|
Skin Late Phase Response (LPR) to Intradermal Testing
Week 26
|
13.50 mm
Interval 8.41 to 18.59
|
13.83 mm
Interval 8.93 to 18.74
|
26.44 mm
Interval 18.68 to 34.2
|
31.28 mm
Interval 23.01 to 39.55
|
|
Skin Late Phase Response (LPR) to Intradermal Testing
Week 52
|
13.67 mm
Interval 9.17 to 18.18
|
10.06 mm
Interval 6.12 to 13.99
|
23.23 mm
Interval 16.17 to 30.28
|
29.36 mm
Interval 18.62 to 40.1
|
|
Skin Late Phase Response (LPR) to Intradermal Testing
Week 104
|
15.58 mm
Interval 11.05 to 20.12
|
14.48 mm
Interval 10.37 to 18.59
|
25.40 mm
Interval 18.27 to 32.53
|
32.38 mm
Interval 21.08 to 43.68
|
SECONDARY outcome
Timeframe: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. Peak TNSS EPR is the highest value recorded between 0 and 1 hour inclusive.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
Baseline
|
9.31 Peak Total Nasal Symptom Score
Interval 8.92 to 9.71
|
9.52 Peak Total Nasal Symptom Score
Interval 9.05 to 9.98
|
9.17 Peak Total Nasal Symptom Score
Interval 8.76 to 9.57
|
8.96 Peak Total Nasal Symptom Score
Interval 8.59 to 9.34
|
|
Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
Week 26
|
3.64 Peak Total Nasal Symptom Score
Interval 2.74 to 4.55
|
5.41 Peak Total Nasal Symptom Score
Interval 4.3 to 6.52
|
6.78 Peak Total Nasal Symptom Score
Interval 5.63 to 7.92
|
7.96 Peak Total Nasal Symptom Score
Interval 7.04 to 8.88
|
|
Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
Week 52
|
3.04 Peak Total Nasal Symptom Score
Interval 2.16 to 3.91
|
4.73 Peak Total Nasal Symptom Score
Interval 3.63 to 5.83
|
6.09 Peak Total Nasal Symptom Score
Interval 4.78 to 7.39
|
6.75 Peak Total Nasal Symptom Score
Interval 5.72 to 7.78
|
|
Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
Week 78
|
4.24 Peak Total Nasal Symptom Score
Interval 3.33 to 5.15
|
4.80 Peak Total Nasal Symptom Score
Interval 3.63 to 5.97
|
6.82 Peak Total Nasal Symptom Score
Interval 5.32 to 8.32
|
5.83 Peak Total Nasal Symptom Score
Interval 4.58 to 7.09
|
|
Peak Total Nasal Symptom Score (TNSS): Early Phase Response (EPR)
Week 104
|
4.67 Peak Total Nasal Symptom Score
Interval 3.59 to 5.74
|
6.16 Peak Total Nasal Symptom Score
Interval 5.13 to 7.19
|
6.85 Peak Total Nasal Symptom Score
Interval 5.3 to 8.4
|
6.12 Peak Total Nasal Symptom Score
Interval 4.46 to 7.77
|
SECONDARY outcome
Timeframe: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78 and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Early Phase Response (EPR) is the TNSS AUC from 0 to 1 hour.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
Baseline
|
5.49 Total Nasal Symptom Score * Hour
Interval 4.99 to 6.0
|
5.59 Total Nasal Symptom Score * Hour
Interval 5.0 to 6.18
|
4.91 Total Nasal Symptom Score * Hour
Interval 4.27 to 5.55
|
5.55 Total Nasal Symptom Score * Hour
Interval 4.96 to 6.15
|
|
Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
Week 26
|
1.83 Total Nasal Symptom Score * Hour
Interval 1.36 to 2.29
|
2.71 Total Nasal Symptom Score * Hour
Interval 2.13 to 3.3
|
3.38 Total Nasal Symptom Score * Hour
Interval 2.69 to 4.08
|
4.09 Total Nasal Symptom Score * Hour
Interval 3.44 to 4.74
|
|
Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
Week 52
|
1.53 Total Nasal Symptom Score * Hour
Interval 1.03 to 2.03
|
2.34 Total Nasal Symptom Score * Hour
Interval 1.74 to 2.93
|
3.07 Total Nasal Symptom Score * Hour
Interval 2.33 to 3.81
|
3.77 Total Nasal Symptom Score * Hour
Interval 2.99 to 4.55
|
|
Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
Week 78
|
2.04 Total Nasal Symptom Score * Hour
Interval 1.42 to 2.66
|
2.31 Total Nasal Symptom Score * Hour
Interval 1.45 to 3.17
|
3.23 Total Nasal Symptom Score * Hour
Interval 2.37 to 4.09
|
2.88 Total Nasal Symptom Score * Hour
Interval 1.93 to 3.84
|
|
Total Nasal Symptom Score (TNSS) Early Phase Response (EPR)
Week 104
|
2.46 Total Nasal Symptom Score * Hour
Interval 1.73 to 3.19
|
2.81 Total Nasal Symptom Score * Hour
Interval 2.13 to 3.49
|
3.66 Total Nasal Symptom Score * Hour
Interval 2.74 to 4.59
|
3.10 Total Nasal Symptom Score * Hour
Interval 2.11 to 4.1
|
SECONDARY outcome
Timeframe: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring nasal congestion and blockade, rhinorrhea, itching, and sneezing. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Higher scores indicate more severe nasal symptoms. The trapezoidal rule was used to calculate the TNSS AUC. The Late Phase Response (LPR) is the TNSS AUC from 5 to 6 hours.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)
Baseline
|
1.36 Total Nasal Symptom Score * Hour
Interval 0.86 to 1.86
|
1.52 Total Nasal Symptom Score * Hour
Interval 0.86 to 2.17
|
1.13 Total Nasal Symptom Score * Hour
Interval 0.7 to 1.57
|
1.25 Total Nasal Symptom Score * Hour
Interval 0.81 to 1.69
|
|
Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)
Week 26
|
0.30 Total Nasal Symptom Score * Hour
Interval 0.13 to 0.47
|
0.67 Total Nasal Symptom Score * Hour
Interval 0.29 to 1.05
|
0.54 Total Nasal Symptom Score * Hour
Interval 0.11 to 0.97
|
0.90 Total Nasal Symptom Score * Hour
Interval 0.5 to 1.3
|
|
Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)
Week 52
|
0.48 Total Nasal Symptom Score * Hour
Interval 0.18 to 0.78
|
0.60 Total Nasal Symptom Score * Hour
Interval 0.2 to 0.99
|
0.24 Total Nasal Symptom Score * Hour
Interval 0.06 to 0.42
|
0.73 Total Nasal Symptom Score * Hour
Interval 0.14 to 1.31
|
|
Total Nasal Symptom Score (TNSS) Late Phase Response (LPR)
Week 104
|
0.69 Total Nasal Symptom Score * Hour
Interval 0.21 to 1.17
|
1.02 Total Nasal Symptom Score * Hour
Interval 0.26 to 1.78
|
0.53 Total Nasal Symptom Score * Hour
Interval 0.2 to 0.85
|
0.76 Total Nasal Symptom Score * Hour
Interval -0.17 to 1.7
|
SECONDARY outcome
Timeframe: 0 to 1 hour of the NAC at: Baseline (Week 0) and Weeks 26, 52 and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Early Phase Response (EPR) is the PNIF AUC from 0 to 1 hour of the NAC.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)
Baseline
|
-15.14 L/min * Hour
Interval -25.62 to -4.66
|
-10.66 L/min * Hour
Interval -20.28 to -1.04
|
-12.48 L/min * Hour
Interval -24.05 to -0.91
|
-10.25 L/min * Hour
Interval -20.01 to -0.49
|
|
Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)
Week 26
|
-2.88 L/min * Hour
Interval -11.19 to 5.44
|
2.26 L/min * Hour
Interval -6.53 to 11.05
|
-11.04 L/min * Hour
Interval -20.13 to -1.95
|
-8.02 L/min * Hour
Interval -22.3 to 6.26
|
|
Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)
Week 52
|
-8.65 L/min * Hour
Interval -19.69 to 2.39
|
-4.90 L/min * Hour
Interval -14.67 to 4.86
|
-0.80 L/min * Hour
Interval -10.86 to 9.25
|
-8.70 L/min * Hour
Interval -17.9 to 0.5
|
|
Peak Nasal Inspiratory Flow (PNIF) Early Phase Response (EPR) Area Under the Curve (AUC)
Week 104
|
-11.35 L/min * Hour
Interval -25.34 to 2.63
|
-11.90 L/min * Hour
Interval -23.05 to -0.75
|
-9.13 L/min * Hour
Interval -24.08 to 5.83
|
-13.09 L/min * Hour
Interval -30.47 to 4.3
|
SECONDARY outcome
Timeframe: Hours 5 to 6 of the NAC at: Baseline (Week 0) and Weeks 26, 52, 78, and 104Population: A cross-sectional analysis of the observed measures within the intent-to-treat was used in the reporting of secondary endpoints.
PNIF is defined as the speed of inspiration of air in Liters per minute when breathing in into the lungs through the nose. Lower scores indicate less ability to breathe air into the lungs due to more severe nasal symptoms. The Late Phase Response (LPR) is the PNIF AUC from hours 5 to 6 of the NAC.
Outcome measures
| Measure |
AMG 157+Cat Immunotherapy
n=32 Participants
AMG 157 will be administered every four weeks.
Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
|
AMG 157 Placebo+Cat Immunotherapy
n=31 Participants
Placebo for AMG 157 of similar appearance will be administered every four weeks.
Cat immunotherapy will be administered weekly.
Cat Immunotherapy: A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
AMG 157+Cat Immunotherapy Placebo
n=30 Participants
AMG 157 will be administered every four weeks.
Placebo for Cat immunotherapy will be administered weekly.
AMG 157: AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
|
Placebo-Placebo
n=28 Participants
Placebo for AMG 157 will be administered every four weeks.
Placebo for cat immunotherapy will be administered weekly.
Cat Immunotherapy Placebo: Placebo for allergen-specific immunotherapy administered subcutaneously
AMG 157 Placebo: Placebo for AMG 157 administered intravenously
|
|---|---|---|---|---|
|
Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
Baseline
|
-52.24 L/min * Hour
Interval -64.31 to -40.17
|
-53.44 L/min * Hour
Interval -63.87 to 43.0
|
-42.49 L/min * Hour
Interval -53.3 to -31.68
|
-50.03 L/min * Hour
Interval -62.32 to -37.74
|
|
Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
Week 26
|
-18.34 L/min * Hour
Interval -29.1 to -7.57
|
-17.35 L/min * Hour
Interval -26.53 to -8.17
|
-40.42 L/min * Hour
Interval -52.09 to -28.75
|
-53.97 L/min * Hour
Interval -68.85 to -39.09
|
|
Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
Week 52
|
-25.29 L/min * Hour
Interval -38.24 to 12.35
|
-23.42 L/min * Hour
Interval -33.78 to -13.07
|
-35.87 L/min * Hour
Interval -51.51 to -20.24
|
-44.71 L/min * Hour
Interval -54.89 to -34.53
|
|
Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
Week 78
|
-31.93 L/min * Hour
Interval -42.14 to 21.73
|
-24.55 L/min * Hour
Interval -36.66 to 12.44
|
-37.56 L/min * Hour
Interval -52.55 to -22.57
|
-42.26 L/min * Hour
Interval -59.7 to -24.81
|
|
Peak Nasal Inspiratory Flow (PNIF) Late Phase Response (LPR) Area Under Curve AUC
Week 104
|
-43.41 L/min * Hour
Interval -61.54 to -25.29
|
-35.98 L/min * Hour
Interval -49.21 to -22.75
|
-49.01 L/min * Hour
Interval -62.18 to -35.84
|
-52.42 L/min * Hour
Interval -69.07 to -35.77
|
Adverse Events
AMG 157+Cat Immunotherapy
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
AMG 157 Placebo+Cat Immunotherapy
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
AMG 157+Cat Immunotherapy Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo-Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG 157+Cat Immunotherapy
n=32 participants at risk
AMG 157 administered every four weeks and Cat immunotherapy administered weekly
|
AMG 157 Placebo+Cat Immunotherapy
n=31 participants at risk
Placebo for AMG 157 administered every four weeks and Cat immunotherapy administered weekly
|
AMG 157+Cat Immunotherapy Placebo
n=29 participants at risk
AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly
|
Placebo-Placebo
n=28 participants at risk
Placebo for AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly
|
|---|---|---|---|---|
|
General disorders
All-Cause Mortality
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Nervous system disorders
Cerebral infarction
|
3.1%
1/32 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
Other adverse events
| Measure |
AMG 157+Cat Immunotherapy
n=32 participants at risk
AMG 157 administered every four weeks and Cat immunotherapy administered weekly
|
AMG 157 Placebo+Cat Immunotherapy
n=31 participants at risk
Placebo for AMG 157 administered every four weeks and Cat immunotherapy administered weekly
|
AMG 157+Cat Immunotherapy Placebo
n=29 participants at risk
AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly
|
Placebo-Placebo
n=28 participants at risk
Placebo for AMG 157 administered every four weeks and Placebo for Cat immunotherapy administered weekly
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
13.8%
4/29 • Number of events 6 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 4 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
General disorders
Injection site pain
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 4 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Immune system disorders
Hypersensitivity
|
18.8%
6/32 • Number of events 36 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
9.7%
3/31 • Number of events 8 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.4%
1/29 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Immune system disorders
Injection site hypersensitivity
|
25.0%
8/32 • Number of events 12 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
9.7%
3/31 • Number of events 4 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 3 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Bronchitis
|
3.1%
1/32 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Gastroenteritis
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.5%
2/31 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Nasopharyngitis
|
28.1%
9/32 • Number of events 14 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
12.9%
4/31 • Number of events 7 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
31.0%
9/29 • Number of events 17 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
32.1%
9/28 • Number of events 16 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.1%
1/32 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Upper respiratory tract infection
|
21.9%
7/32 • Number of events 9 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
19.4%
6/31 • Number of events 9 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
17.2%
5/29 • Number of events 10 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
21.4%
6/28 • Number of events 7 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
10.3%
3/29 • Number of events 3 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.4%
3/32 • Number of events 4 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.5%
2/31 • Number of events 7 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 3 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.5%
2/31 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.1%
1/32 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
12.9%
4/31 • Number of events 12 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 15 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
10.7%
3/28 • Number of events 4 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Nervous system disorders
Migraine
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 3 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.4%
1/29 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.4%
1/29 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.6%
1/28 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.4%
1/29 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/31 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
6.9%
2/29 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/28 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/32 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
3.2%
1/31 • Number of events 1 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
0.00%
0/29 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
7.1%
2/28 • Number of events 2 • 2 years
Total number at risk is reported for the Safety population;one participant was randomized and discontinued prior to starting Study Therapy,thus not included in the Safety population. 1\. Local reactions/AEs:FDA Guidance,Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Sep 2007) 2. Systemic AEs:WAO Subcutaneous Immunotherapy Systemic Reaction Grading System 3.Other AE's: NCI Common Terminology Criteria for Adverse Events (V4.03).
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place